1,165 Results for

Quality Assurance Lead Jobs in Massachusetts

Jobs

Quality Manufacturing Lead SOFIE

Haverhill, MA

Ensure team members are trained and authorized to identify, escalate, and participate in resolving quality issues; encourage operators to identify problems and stop processes when necessary to fix issues and foster a sense of ownership. Ensure manufacturing and analytical equipment are properly maintained and calibrated, and that applicable maintenance and system suitability activities are performed within intervals specified in equipment SOPs.

20 days ago

Quality Manager Rotating Machinery Services

Chicopee, MA

$110,000–$120,000
Full time

The goal was to provide turbomachinery operators with unparalleled service built on established relationships, solid engineering, and technical expertise backed by responsiveness, competitive pricing, and lead times. Review and approve inspection reports, first article inspection reports (FAIRs), and material certifications; ensure documentation is complete and traceable before components are released.

30+ days ago

Senior Quality Engineer Jobot

Danvers, MA

$110,000–$140,000 / year

Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. 3. Proven experience in driving corrective actions, conducting root cause analysis, managing nonconformances, and overseeing the quality of electro-mechanical products.

12 days ago

Assurance Experienced Manager, Third Party Attestation bdo consulting

Boston, MA

$130,000–$170,000 / year

This role focuses on various types of reports, including System and Organization Controls (SOC) 1, SOC 2, SOC 3, SOC for Cybersecurity, WebTrust for CAs, HITRUST, SSPA, ISO, MRC, and CSA STAR. The annual allocation to the ESOP is fully funded by BDO through investments in company stock and grants employees the chance to grow their wealth over time as their shares vest and grow in value with the firm’s success, with no employee contributions.

4 days ago

Lead - Mammography Technologist - $28-44 per hour Tenet Massachusetts

Fayville, MA

$28–$44 / hour

Healthgrades awarded Saint Vincent Hospital #1 in Cardiology in the state and one of America’s 100 Best Hospitals for Coronary Intervention in 2023 and 2024, which puts Saint Vincent Hospital in the top 5% of hospitals nationwide for coronary intervention. We continue to be leaders in state-of-the-art treatments like our CyberKnife Radiosurgery, and our Cardiac Rehabilitation Program which offers a unique, specialized approach to overcoming heart health challenges.

4 days ago

Director, Commercial Risk Evaluation and Mitigation Strategies (REMS) Lead - Remote Agios Pharmaceuticals

Boston, MA

Remote

$183,549–$230,312 / year

The Director leads the development, implementation, and ongoing management of commercial related REMS activities to support compliance, patient safety, and effective execution across sales, field marketing, patient support, specialty distribution and other customer-facing teams. The current base salary range for this position is expected to be between $183,549 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.

27 days ago

Quality Manager Michael Page USA

Milford, MA

$115,000–$120,000 / year
Full time

Lead root cause investigations on machining and manufacturing issues using structured problem-solving tools (5 Whys, FMEA, etc.). Analyse key quality data (scrap, rework, yield, returns) to identify trends and implement improvements.

19 days ago

Quality Assurance Lead Virtusa Corp

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30+ days ago

Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU) Prilenia

Europe, Massachusetts

Remote

About Prilenia Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Director/Senior Director, GCP Quality Assurance Lead, to support programs in both Huntington’s Disease and ALS. The ideal candidate is both a hands-on quality practitioner and a strategic partner to Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics, combining deep GCP/GvP/GLP expertise with the executive presence to influence cross-functional teams and senior leadership.

30+ days ago

Training and Quality Assurance Lead Old Colony Elder Services

Brockton, MA

Full time

Our mission: Through the talents of an experienced and diverse workforce, OCES supports the independence and dignity of older adults and individuals with disabilities by providing essential information and services that promote healthy, safe living which positively impacts our community. They will work with agency leadership to provide industry intelligence and actionable solutions to programmatic staff resulting in improvement in OCES' clinical, designation and strategic goals.

30+ days ago

Product Quality Lead (APQR & QA CMC Support) Genetix Biotherapeutics

Somerville, Massachusetts

The Product Quality Lead (APQR & QA CMC Support) is a key member of the QA Compliance organization, responsible for ensuring quality oversight of regulatory submissions and lifecycle management for Genetix Biotherapeutics (GTX) products. Additionally, the Associate Director partners cross-functionally and with external vendors to support health authority inspection readiness activities, mock inspections and internal audits.

30 days ago

Director, U.S. Commercial QA Lead (GMP) Pharvaris NV

Boston, MA

$195,000–$225,000 / year

Strategic thinking, business acumen, analytical mindset with strong attention to details, with proven ability to motivate, influence, negotiate, and collaborate with internal and external stakeholders through efficient management of relationship within a cross-functional matrix. We aim at bringing new, more convenient options to bradykinin-mediated angioedema patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening.

30+ days ago

QA Test Lead Capital Markets Artech LLC

North Quincy, MA

$38–$44 / hour

Desirable Skills: Keyword: Skills: Manual Testing Processes and Management~Capital Markets and Financial Services. Should have experience in functional| regression| performance testing Should have experience in offshore co-ordination Should have experience in stakeholer management at onsiteNice to have.

16 days ago

Lead SDET Quality Assurance Engineer oneZero Financial Systems LLC

Somerville, MA

$115,000–$145,000 / year

Promotes automation first approach to test plans that incorporate both positive and negative scenarios Identifies functional interdependencies between squads that optimizes testing of related/dependent features that are cross-squad and cross-team Participates and leads in postmortem activities to better understand and automate escapes and implement process improvements Understands each tier of the testing pyramid and the how to use the different automation solutions for them Helps ensure both stories and epics meet both Definition of Ready (DoR) and Definition of Done (DoD) Applies test-first BDD and TDD best practices. EXPERIENCE/EDUCATIONAL REQUIREMENTS: Bachelor's/Master's degree in the Hard Sciences (Computer Science, Math, Engineering preferred) 10+ years of software development or automation development or technical team leadership experience Demonstrable experience with some of CI/CD, BDD/TDD, C#, Relational Databases and Python/JavaScript Experience with performance tools like Neoload/JMeter/Etc Familiarity with Playwright Experience managing technical automation QA teams in an agile and CI/CD environment Finance industry experience Experience using generative AI within a development environment.

30+ days ago

SR Lead QA Analyst Integrated Resources, Inc

Cambridge, Massachusetts

Contractor

QualificationsThorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelinesThorough knowledge of IT Controls methodologies, including GAMP5 and ITILExcellent communication skills, both verbal and writtenDetailed knowledge of the IT system development life cycle and software quality assurance in a regulated environmentKnowledge of general software and database conceptsExperience with risk analysis and risk management practices and toolsKnowledge of infrastructure technology and platformsThe ability to work both independently and with teams at various levels in the organizationExcellent organizational skills and attention to detail and accuracyFive or more years of experience in computerized system validation within a regulated environment Provide quality assurance oversight for system related issues (deviations, incidents, etc.)Assist in the development of IT ControlsAdvise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.

1 day ago

Sr Lead QA Analyst Integrated Resources, Inc

Cambridge, Massachusetts

Contractor

QualificationsQualifications:Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelinesThorough knowledge of IT Controls methodologies, including GAMP5 and ITILExcellent communication skills, both verbal and writtenDetailed knowledge of the IT system development life cycle and software quality assurance in a regulated environmentKnowledge of general software and database conceptsExperience with risk analysis and risk management practices and toolsKnowledge of infrastructure technology and platformsThe ability to work both independently and with teams at various levels in the organizationExcellent organizational skills and attention to detail and accuracyFive or more years of experience in computerized system validation within a regulated environment Provide quality assurance oversight for system related issues (deviations, incidents, etc.)Assist in the development of IT ControlsAdvise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.

1 day ago

QA Compliance Lead Integrated Resources, Inc

Marlborough, Massachusetts

Contractor

charts and docs or temp related excursions - Review and update label issuance and reconciliation processGeneral QA documentation support to include the following: - Issuance of batch records and issuance and tracking of log books, lab notebooks, and SOP binders - Scanning and filing of excursion docs and client related batch docs to support batch release - Develops process improvement plans using a variety of quality and continuous process improvement tools, including but not limited to Six Sigma, Lean Manufacturing, SS, SPC, engineering studies, DOE Gauge R&R, etc. - Communicates and implements a strategy to ensure compliance - Responsible for review of batch records in support of disposition of bulk drug substance - Responsible for review of equipment validation protocols and report - General compliance quality systems management support for the following areas: - Raw material and solution release - Review of raw material specifications and solution docs - Release of single use disposable product to include label reconciliation - Review of temp.

1 day ago

Senior Manager Product Development Quality Assurance CMC Product Lead AbbVie Inc

Worcester, MA

As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paidand may be modified at the Company's sole and absolute discretion, consistent with applicable law.

23 days ago

Quality Assurance Team Lead ZOLL Medical

Chelmsford, Massachusetts

Remote

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. The Quality Assurance Team Leader supervises a small team of Quality Assurance Technicians and is responsible for monitoring and ensuring products are safe and meet customer expectations.

5 days ago

Quality Assurance Automation Lead Faro Health Inc

We are a hybrid workplace where San Diego employees work from their homes as well as in our stunning main headquarters enjoying a gym with classes and (early next year) spa services, outdoor lawn work area, and steeply discounted food hall. Faro is a mission driven company seeking world class people who share our passion for improving drug availability and patient outcomes through better clinical trial design.

30+ days ago

Director, Clinical Quality Assurance Seaport Therapeutics

Boston, Massachusetts

$198,000–$225,000 / year

The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. Seaport Therapeutics is seeking an experienced Director, Clinical Quality Assurance to manage clinical quality activities supporting clinical development programs, ensuring compliance with regulatory requirements and company policies.

30+ days ago

Senior Specialist, Field Quality QA Operations Bristol-Myers Squibb Co

$89,530–$108,490 / year

The Senior Field QA Specialist is responsible for reviewing Manufacturing Batch Records (MBRs), performing real time on-the-floor exceptions reviews and logbooks, conducting GMP area walkthroughs, and supporting timely return-to-service (RTS) walkthroughs to confirm that manufacturing areas and equipment are properly cleaned, calibrated, and ready for production use. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

30+ days ago

Quality Associate, QA Operations Obsidian Therapeutics Inc

Bedford, MA

$95,500–$117,000 / year

Provide timely QA support for change controls, GMP investigations, associated CAPAs, and effectiveness checks by reviewing records, supporting impact assessments, tracking action items, and helping ensure quality system activities are completed accurately and within required timelines. Serve as a point of coordination for QA support across manufacturing operations by partnering with CMC, QA Operations, and Supply Chain/materials management teams to review documentation, resolve quality-related questions, and support timely execution of GMP activities.

4 days ago

Senior Quality Assurance Engineer (OT / Security Platforms) Industrial Defender, Inc. (Inactive)

Boston, MA

$115,000–$140,000 / year

We are looking for a Senior Quality Assurance Engineer to join our experienced QA team working on a multi-tier security platform for industrial and operational environments. This role is intended for an experienced QA engineer who can independently execute complex testing contribute to quality discussions and raise issues early.

30+ days ago

Manager, CDx Quality Assurance Foundation Medicine Inc

Boston, MA

$123,600–$154,500 / year

Partnering closely with Regulatory Affairs, Quality Systems, Complaints, Risk Management, Diagnostic Development and Validation, Clinical Operations, R&D, and Global Lab Operations, this role provides leadership, governance, and operational oversight to ensure CDx programs are executed with patients and users at the forefront, safety, and high quality as the north star. Partner with cross functional stakeholders (Quality, Regulatory Affairs, Diagnostic Development and Validation, Clinical Operations Product, Research and Development, Operations, Laboratory, IT, and Clinical/Lab interfaces) to ensure Medical Device Products and IVD are developed with patient safety first and right the first time mentality.

30+ days ago

Director, Clinical Quality Assurance Oruka Therapeutics

Waltham, Massachusetts

Remote

This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections. The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka’s clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials.

30+ days ago

Associate Director / Director, Clinical Quality Assurance Beam Therapeutics

Cambridge, MA

$185,000–$260,000 / year

Reporting to the Senior Director, Clinical Quality Assurance, this role will provide strategic and operational leadership for inspection readiness, program quality oversight, and vendor oversight as Beam advances toward its first regulatory submission and potential associated inspections. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA.

30+ days ago

Aerospace QA Engineer (Quality Engineer) Redwire Space

Marlborough, Massachusetts

$85,000–$110,000 / year

To conform to U.S. Government space technology export regulations, including the International Traffic in Arms Regulations (ITAR) you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State. These cutting-edge capabilities address cost and performance limitations that are helping to revolutionize spaceflight and are currently being utilized on missions with NASA, the Department of Defense, and several commercial space companies.

5 days ago

Director, Clinical Quality Assurance Oruka Therapeutics Inc

Waltham, MA

Remote

$213,000–$240,000 / year

Role Overview: The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka's clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials. This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

30+ days ago

Associate Director / Director, Clinical Quality Assurance Beam Therapeutics Inc

Cambridge, MA

$185,000–$260,000 / year

30+ days ago

Associate Director, GMP QA Operations Dyne Therapeutics Inc

Waltham, MA

$160,000–$195,000 / year

Role Summary: The Associate Director, QA Operations serves as the QA technical lead for external manufacturing and testing project teams, ensuring the effective development, implementation, and continuous improvement of Quality Systems, procedures, policies, and metrics supporting GMP activities. 5+ years of related work experience in Quality Assurance or closely related role within Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry, preferably with experience overseeing CMO/CDMO organizations.

19 days ago

Quality Assurance Specialist III Raw Material/Batch Record Review Nitto Denko Avecia Inc

Milford, MA

$73,700–$89,177 / year

Perform QA-related entries and reviews in inventory management systems (e.g., SAP or LIMS) related to raw material status changes (quarantine/release/reject). Attend or lead all raw material meetings including interaction with other departments such as QC, Milford Supply Chain, Cincinnati Supply Chain, etc.

22 days ago

Aerospace QA Engineer (Quality Engineer) Redwire Corp

Marlborough, MA

$85,000–$110,000 / year

These cutting-edge capabilities address cost and performance limitations that are helping to revolutionize spaceflight and are currently being utilized on missions with NASA, the Department of Defense, and several commercial space companies. To conform to U.S. Government space technology export regulations, including the International Traffic in Arms Regulations (ITAR) you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

5 days ago

Production QA - Quality Manager Safariland LLC

Dalton, MA

At Safariland our colleagues are some of the best and brightest in the industry and we are seeking new team members who exhibit the diverse competencies that will drive The Safariland Group to even greater success while maintaining our culture of being a great place to work. We cultivate a work culture driven by our 4 core values; integrity, curiosity, excellence and empowerment and we want associates to be involved in their work and communities so they can achieve their highest level of wellbeing.

20 days ago

Quality Assurance Specialist - Supplier Quality Actalent Inc

Framingham, MA

$38–$40 / hour

Experience supporting supplier quality activities, including supplier qualification and assessments, performance monitoring, corrective and preventive action (CAPA) management, and change control processes. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

3 days ago

Quality Assurance Supervisor - 2nd Shift Dessert Holdings Inc.

Newburyport, Massachusetts

Dessert Holdings is a collection of premium dessert companies and brands: The Original Cakerie, Lawler's Desserts, Atlanta Cheesecake Company, Steven Charles, Dianne's Fine Desserts, Kenny's Great Pies, and Willamette Valley Pie Company. With a rich heritage spanning seven distinctive brands, we bring unmatched expertise and tailored solutions to our Retail and Foodservice partners.

30+ days ago

Associate Director, GMP Quality Assurance Operations Kiniksa Pharmaceuticals International Plc

Lexington, MA

Kiniksa is seeking an experienced Associate Director, GMP Quality Assurance Operations to be a key leader within the Quality organization, responsible for providing hands-on-Quality Operations oversight for GMP manufacturing activities supporting clinical programs. Responsibilities (including, but not limited to): Lead and execute GMP QA activities for development programs, including manufacture of master cell bank, working cell bank, drug substance and drug product/finished goods, in alignment with Kinika's Quality System.

30+ days ago

Sr. Manager, Design Quality Assurance Foundation Medicine Inc

Boston, MA

$153,200–$191,500 / year

Partnering closely with Product Development, Regulatory Affairs, Quality Systems, Complaints, Risk Management, R&D, and Global Lab Operations, this role provides strategic leadership, governance, and operational oversight to ensure products are designed and developed with patients and users at the center, safe, high quality, and inspection ready. Partner with senior Quality leadership to align Medical Device and IVD Product Development governance with broader FMI organization responsible for Product Development, including but not limited to Regulatory Affairs, Clinical Operations, Product, Research and Development, Operations.

30+ days ago

Manager/Sr. Manager QA Supply Chain Oruka Therapeutics

Waltham, Massachusetts

The Manager / Senior Manager, QA Supply Chain is responsible for providing quality oversight of clinical supply chain activities supporting Phase 2 and Phase 3 programs, including packaging, labeling, distribution, and cold chain management. This role ensures that all supply chain operations are conducted in compliance with cGMP, GCP, and GDP requirements, with a focus on IRT-driven clinical supply management, temperature control, and investigational product traceability.

30+ days ago

Senior Quality Assurance Software Engineer Cooley LLP

Boston, MA

$103,000–$150,000 / year

We offer a full range of elective benefits including medical, health savings account (with applicable medical plan), dental, vision, health and/or dependent care flexible spending accounts, pre-tax commuter benefits, life insurance, AD&D, long-term care coverage, backup care for children and/or adults and other parental support benefits. In addition to elective benefit options, benefited employees receive firm-paid life insurance, AD&D, LTD, short term medical benefits as well as 21 days of Paid Time Off ("PTO") and 10 paid holidays each year.

30+ days ago

Quality Assurance Manager (Food) Collinwood Technology Partners, LLC

Hadley, MA

This role will serve as the site authority on quality systems and regulatory compliance, and you will oversee the implementation of the Food Safety Plan, ensuring compliance with all applicable FDA regulations (21 CFR 111 and 117) and manage the site Quality Management System (QMS). • Lead and manage site Preventive Controls-based Food Safety and Quality Management System (FSQMS), including SOPs, change control, training and document control.

6 days ago

Senior Software Quality Assurance Engineer Katalyst Healthcares & Life Sciences

Andover, MA

Job Description As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end to end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products. In this role you will play a key role in: Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management).

30+ days ago

Group Risk Specialist - Quality Assurance The Toronto-Dominion Bank

Boston, MA

$91,000–$145,600 / year

Additional Responsibilities: The Group Risk Manager is an enterprise role which works with various stakeholders across Risk Management and Technology, including but not limited to, Non-Financial Risk Management, Compliance, Financial Crimes, Audit, Enterprise Protect, and Platforms and Technology teams that support Risk. Total Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition.

4 days ago

Senior Software Quality Assurance Engineer Karwell Technologies

Andover, MA

Job Description: As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end to end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post market activities.

30+ days ago

Senior Manager, Clinical Quality Assurance Kura Oncology Inc

Boston, MA

$160,000–$187,000 / year

ESSENTIAL JOB FUNCTIONS: Reporting to the Executive Director of Quality Assurance, the Senior Manager, Clinical Quality Assurance (CQA) is responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs. Kura developed and is commercializing KOMZIFTI (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition.

30+ days ago

Director, Quality Assurance (Operations) Zevra Therapeutics Inc

Boston, MA

10+ years of progressive experience in pharmaceutical/biotech industry with expertise in establishing effective and efficient systems and processes supporting pre-clinical, clinical and commercial programs, 7+ years of Quality leadership experience with a successful track record in vendor oversight and managing relationship with external stakeholders as well as internal QA systems in a virtual environment, 7+ years' experience in the establishing and administering of GCP-, GLP- and GDP compliant systems, Bachelors or Advanced degree in a scientific or related discipline, Understanding of worldwide requirements of GxP compliance and quality systems for clinical and commercial products, Leadership role in the management of regulatory/health authorities inspections, Experience with new product launch and implementation of serialization systems and commercial product complaint processes is a plus, Strong team player that has a customer service approach and is solution oriented, Ability to travel both domestically and internationally as needed, likely to be ~10 15%, The candidate will need to embrace Zevra's mission and core values, Ability to effectively communicate with inspiration, lead and influence individuals from multiple functional departments at all levels of the organization, Strong organizational and time management skills to balance working on multiple projects and initiatives in parallel, A proven self-starter capable of high performance with limited direction and oversight, Excellent people leader with strong mentorship skills. This includes, but is not limited to, audit planning and execution, reporting and coordination with external contractors, Supports periodic GxP training and ensure that training requirements are consistently met, as required, In collaboration with Head of Quality and other department heads, prepare, review, approve, and implement SOPs as required, Responsible for Quality Review Boards, providing technical expertise for product quality decisions, Responsible for manufacturing investigations, in collaboration with the Manufacturing Team, ensuring appropriate corrective and preventive actions are taken as required, Support continuous improvement initiatives to optimize Zevra's quality and compliance position, Cross-train and serve as back-up for Quality Systems, as assigned.

16 days ago

Senior Data Quality Assurance Analyst TalentBurst, Inc.

Quincy, MA

$64–$67 / hour

This includes creating a consolidated Enterprise Data Platform on modern cloud tools (including AWS & Snowflake,) and re-platforming existing business data applications from solutions such as SAS and legacy databases to the new platform. This position works collaboratively with epidemiologists, program staff, analytics teams, developers, and external partners to maintain data integrity across state public health information systems and reporting processes.

25 days ago

Quality Assurance Manager Minerals Technologies Inc

Working Conditions: While performing the duties of this job, the employee is typically required to have the ability to work in an office environment, using office equipment as needed, read, write, listen, speak, and understand English, follow instructions and other oral/written information, compose correspondence in a professional manner, complete paperwork and other documentation accurately, work independently and with others, communicate effectively with all individuals internal and external to the organization, analyze information/situations as needed, be organized and detail-oriented, be able to identify/judge the urgency of a situation, use judgment in decision making and use creativity and negotiation when necessary. Pro-actively maintains compliance with FDA and other worldwide pharmacopeia programs (where applicable) including but not limited to maintaining cGMP compliance, HACCP program, facility registration with FDA and ISO 21000 and other pertinent food defense programs.

30+ days ago

Director of Software Quality Assurance PreVeil

Boston, Massachusetts

You will set testing strategy, mentor and grow the QA team, and work closely with Engineering, Security, and Compliance so that every release — especially file sync, sharing, and storage functionality — holds up under real-world usage and regulatory scrutiny alike. Reporting to the VP of Engineering, you will take ownership of a QA function that today is largely manual and hands-on — deeply skilled at finding real-world, at-scale issues in our web, Windows, and macOS applications — and grow it into a more mature, automation-forward organization without losing that rigor.

6 days ago

Manager/Sr. Manager QA Supply Chain Oruka Therapeutics Inc

Waltham, MA

$146,000–$161,000 / year

Role Overview: The Manager / Senior Manager, QA Supply Chain is responsible for providing quality oversight of clinical supply chain activities supporting Phase 2 and Phase 3 programs, including packaging, labeling, distribution, and cold chain management. This role ensures that all supply chain operations are conducted in compliance with cGMP, GCP, and GDP requirements, with a focus on IRT-driven clinical supply management, temperature control, and investigational product traceability.

30+ days ago

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Quality Assurance Lead Jobs in Massachusetts

Quality Manufacturing Lead SOFIE

Quality Manager Rotating Machinery Services

Senior Quality Engineer Jobot

Assurance Experienced Manager, Third Party Attestation bdo consulting

Lead - Mammography Technologist - $28-44 per hour Tenet Massachusetts

Director, Commercial Risk Evaluation and Mitigation Strategies (REMS) Lead - Remote Agios Pharmaceuticals

Quality Manager Michael Page USA

Quality Assurance Lead Virtusa Corp

Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU) Prilenia

Training and Quality Assurance Lead Old Colony Elder Services

Product Quality Lead (APQR & QA CMC Support) Genetix Biotherapeutics

Director, U.S. Commercial QA Lead (GMP) Pharvaris NV

QA Test Lead Capital Markets Artech LLC

Lead SDET Quality Assurance Engineer oneZero Financial Systems LLC

SR Lead QA Analyst Integrated Resources, Inc

Sr Lead QA Analyst Integrated Resources, Inc

QA Compliance Lead Integrated Resources, Inc

Senior Manager Product Development Quality Assurance CMC Product Lead AbbVie Inc

Quality Assurance Team Lead ZOLL Medical

Quality Assurance Automation Lead Faro Health Inc

Director, Clinical Quality Assurance Seaport Therapeutics

Senior Specialist, Field Quality QA Operations Bristol-Myers Squibb Co

Quality Associate, QA Operations Obsidian Therapeutics Inc

Senior Quality Assurance Engineer (OT / Security Platforms) Industrial Defender, Inc. (Inactive)

Manager, CDx Quality Assurance Foundation Medicine Inc

Director, Clinical Quality Assurance Oruka Therapeutics

Associate Director / Director, Clinical Quality Assurance Beam Therapeutics

Aerospace QA Engineer (Quality Engineer) Redwire Space

Director, Clinical Quality Assurance Oruka Therapeutics Inc

Associate Director / Director, Clinical Quality Assurance Beam Therapeutics Inc

Associate Director, GMP QA Operations Dyne Therapeutics Inc

Quality Assurance Specialist III Raw Material/Batch Record Review Nitto Denko Avecia Inc

Aerospace QA Engineer (Quality Engineer) Redwire Corp

Production QA - Quality Manager Safariland LLC

Quality Assurance Specialist - Supplier Quality Actalent Inc

Quality Assurance Supervisor - 2nd Shift Dessert Holdings Inc.

Associate Director, GMP Quality Assurance Operations Kiniksa Pharmaceuticals International Plc

Sr. Manager, Design Quality Assurance Foundation Medicine Inc

Manager/Sr. Manager QA Supply Chain Oruka Therapeutics

Senior Quality Assurance Software Engineer Cooley LLP

Quality Assurance Manager (Food) Collinwood Technology Partners, LLC

Senior Software Quality Assurance Engineer Katalyst Healthcares & Life Sciences

Group Risk Specialist - Quality Assurance The Toronto-Dominion Bank

Senior Software Quality Assurance Engineer Karwell Technologies

Senior Manager, Clinical Quality Assurance Kura Oncology Inc

Director, Quality Assurance (Operations) Zevra Therapeutics Inc

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