Manager, GMP Quality Assurance - Clinical, QA - Remote Agios PharmaceuticalsManager, GMP Quality Assurance - Clinical, QA - RemoteBoston, MARemote$110,029–$165,044 / yearThe current base salary range for this position is expected to be between $110,029 and $165,044 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. The Manager, GMP Quality Assurance, Clinical will be responsible for responsible for supporting and maintaining high quality levels on Agios Drug Substance and Drug Product by Contract Manufacturing Organizations (CMOs).
NewTravel Director of Respiratory Therapy - $4,419 per week American TravelerTravel Director of Respiratory Therapy - $4,419 per weekCambridge, MAAmerican Traveler is seeking a Director of Respiratory Therapy with proven leadership experience in acute and critical care for a multi-campus health system, requiring prior travel assignment experience and an active MA RRT license. Leadership role overseeing Respiratory Care, PFT Lab, Blood Gas Lab, Sleep Lab, and Cardiopulmonary Rehab departments across three hospital campuses.
Director of Growth - Remote Ava LabsDirector of Growth - RemoteBoston, MARemoteThe company was founded by Cornell computer scientists, who partnered with Wall Street veterans and early Web3 leaders to execute a promising vision for redefining the way people build permissionless networks. Marketing and product knowledge: Familiarity with various marketing channels (SEO, SEM, social media, content marketing) and product development processes.
Director of Operations - Medical Device - Southbridge, MA Michael Page USADirector of Operations - Medical Device - Southbridge, MASouthbridge, MA$175,000–$200,000 / yearFull timeThis role is responsible for driving operational performance, developing high-performing teams, improving efficiency, and ensuring the successful execution of site objectives related to quality, delivery, cost, and growth. With extensive capabilities across metals, plastics, automation, and advanced manufacturing technologies, the company supports the development and production of life-enhancing medical products.
Quality Manufacturing Lead SOFIEQuality Manufacturing LeadHaverhill, MAEnsure 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.
NewDirector - Infrastructure, Capital Projects & Climate Advisory (Project/Program Development & Finance) KPMGDirector - Infrastructure, Capital Projects & Climate Advisory (Project/Program Development & Finance)Boston, MAIf you're looking for a firm with a strong team connection where you can be your whole self, have an impact, advance your skills, deepen your experiences, and have the flexibility and access to constantly find new areas of inspiration and expand your capabilities, then consider a career in Advisory. Qualifications: Minimum eight years of recent experience in relevant advisory consulting roles with increasing responsibilities – sector focus in at least one of transportationand/or ENR and experience with project finance transactions including financialmodeling.
Director, Commercial Risk Evaluation and Mitigation Strategies (REMS) Lead - Remote Agios PharmaceuticalsDirector, Commercial Risk Evaluation and Mitigation Strategies (REMS) Lead - RemoteBoston, MARemote$183,549–$230,312 / yearThe 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.
Tax Managing Director, Core Tax Services bdo consultingTax Managing Director, Core Tax ServicesBoston, MA$190,000–$335,000 / yearThe Tax Managing Director is responsible for applying industry specific knowledge to advice clients on the tax implications of their business objections, evaluating and selecting alternative actions to lessen tax burden and cost of compliance, identifying different methods of complying with tax regulations while acting as the primary client contact for complex tax issues. Develops an in-depth understanding of the technical and practical issues and opportunities regarding one or more areas of taxation, e.g., individual, corporate, property, sales, corporate, pass-through, state and local, international, expatriate, transfer pricing, credits and incentives, compensation and benefits, accounting methods, R&D tax benefits.
Transaction Advisory Managing Director - Financial Due Diligence (FDD) bdo consultingTransaction Advisory Managing Director - Financial Due Diligence (FDD)Boston, MA$250,000–$400,000 / yearLeads complex deal related issues and provides appropriate insight into deal specific matters, including but not limited to quality of earnings adjustments, pro-forma/normalization calculations, working capital analysis and definition, debt and debt-like analysis, warranties & indemnities, sale and purchase agreement review. Ten (10) years of prior financial statement related professional services experience, of which at least five (5) years has been spent in a dedicated TAS environment, to include complex national and multi-national buy and sell side transactions, required; carve-out experience, preferred.
Business Development Director (Financial Services) bdo consultingBusiness Development Director (Financial Services)Boston, MA$150,000–$180,000 / yearUpon completion of the prospect targeting onboarding program, generates opportunities with targeted prospects through agreed upon lead generation activities including cold calling, telemarketing campaigns, direct mail and e-mail campaigns, web seminars/seminars, business community outreach, networking, sponsorships referral development, and other lead generation programs as defined in the office/industry business development plan. Under the direction of the Business Development Market Leader or Business Development Managing Director, and in collaboration with the Practice Leaders and the Chief Business Development Officer, the Director, Business Development will be responsible for achieving local office and/or industry revenue goals by building market presence and identifying and helping pursue new business opportunities in line with firm, regional, local office, and industry business strategies.
NewSpecialist Director, Managed Security Testing KPMGSpecialist Director, Managed Security TestingBoston, MA$169,005–$370,530 / yearIf you're looking for a firm with a strong team connection where you can be your whole self, have an impact, advance your skills, deepen your experiences, and have the flexibility and access to constantly find new areas of inspiration and expand your capabilities, then consider a career in Advisory. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, and safeguard business operations and company reputation.
Tax Managing Director, Alternative Investments bdo consultingTax Managing Director, Alternative InvestmentsBoston, MA$190,000–$335,000 / yearThe 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. This role in our Alternative Investments practice assists in providing tax compliance & consulting services to our Venture Capital, Private Equity, Hedge Fund, and Real Estate clients.
Tax Director, State & Local Tax bdo consultingTax Director, State & Local TaxBoston, MA$99,750–$262,500 / yearAnalyzes and applies client specific facts to published state guidance and determines where additional outreach is needed and develops a strategy for obtaining clarification where needed (e.g., informal consults with state taxing authority, formal letter ruling request, etc.). Identifies out of scope compliance areas in need of additional workstreams (e.g., nexus study, apportionment study, taxability study, etc.) and is able to communicate effectively to stakeholders relative to pricing and need.
Mergers & Acquisitions Tax Managing Director, State and Local Tax bdo consultingMergers & Acquisitions Tax Managing Director, State and Local TaxBoston, MA$157,500–$420,000 / yearThe Tax Managing Director, State and Local Taxation is responsible for providing written tax advice to clients, evaluating and alternate courses of action to lessen tax burden and cost of compliance, recognizing potential tax risks and identifying potential changes in tax policy and regulations. Additionally, the Tax Managing Director, State and Local Taxation is a critical part of the office’s / region’s Tax Services leadership team, and will act as a source for guidance on complex tax questions and issues.
Unit Manager/RN Supervisor Care-OneUnit Manager/RN SupervisorNorthampton, MAParticipate as needed and/or directed in collaboration with the Resident Assessment/Care Plan Coordinator in the development of a written care plan (preliminary, interim and comprehensive for each resident that identifies the problems/needs of the resident, indicates the care to be given, goals to be accomplished and which professional service is responsible for each element of care. Attend, participate and lead the weekly resident "At Risk" meeting ensures resident care and condition concerns are identified, interventions are appropriate to cause and follow up is completed.
Product Manager, Site Integrations and Payments - Remote PAR TechnologyProduct Manager, Site Integrations and Payments - RemoteBoston, MARemoteYou will work closely with customers, engineering and design teams, and internal stakeholders to define integration requirements, drive roadmap execution, and ensure the platform meets the operational and business needs of our fuel and convenience partners. Embracing our "Better Together" ethos, we offer Unified Customer Experience solutions, combining point-of-sale, digital ordering, loyalty and back-office software solutions as well as industry-leading hardware and drive-thru offerings.
NewLaboratory Supervisor - Blood Bank Sante Consulting LLCLaboratory Supervisor - Blood BankBoston, MAAssociate’s degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements – Bachelor’s degree is a plus. All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Global Category Manager Waters CorporationGlobal Category ManagerMilford, MAWe collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Reporting to the Director of Global Procurement, the Global Category Manager is responsible for developing and executing global category strategies and coordinating with other category managers to leverage spend across the organization’s medical device portfolio.
NewTravel Radiology Tech in Attleboro, MA TalentBurst Inc.Travel Radiology Tech in Attleboro, MAAttleboro, MAThis leadership role requires extensive experience in imaging, strong management skills, and thorough knowledge of various imaging modalities to include X-RAY, IR, CT, MRI, Mammography, Ultrasound, Nuclear Medicine and Vascular Services. Leads and manages daily operations of Diagnostic and Interventional Radiology, Vascular, MRI, CT, Ultrasound, Mammography, and Nuclear Medicine, ensuring efficient, high-quality services to meet patient and physician need.
Director Of Quality Assurance - CMO/ CDMO RPM ReSearchDirector Of Quality Assurance - CMO/ CDMOWaltham, MassachusettsHas knowledge and skills across a range of Quality practices, procedures, and principles, with an astute ability to easily rank priorities based on importance and feel comfortable making decisions on quality issues. Demonstrate knowledge of and instruct department procedures and company policies, pay attention to detail in all areas, and ensure all the paperwork is completed completely, neatly, and fully.
NewDirector of Software Quality Assurance PreVeil LLCDirector of Software Quality AssuranceBoston, MAYou 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.
Director of Software Quality Assurance PreVeilDirector of Software Quality AssuranceBoston, MassachusettsYou 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.
Director/Senior Director of Asset Quality Assurance Formation Bio IncDirector/Senior Director of Asset Quality AssuranceMA$185,500–$232,000 / yearYou hold a bachelor's or advanced degree in a scientific, engineering, or related discipline, with extensive multidisciplinary GxP experience in biopharma quality assurance leadership, ideally within a fast-paced biotech that has successfully transitioned from early-stage to commercial. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials.
SENIOR QUALITY ASSURANCE DIRECTOR Compass Group North AmericaSENIOR QUALITY ASSURANCE DIRECTORBoston, MAThis role oversees brand wide food safety programs, supplier controls, operational audits, crisis management, and regulatory compliance across all jurisdictions. The director partners closely with Operations, Supply Chain, Training, and Culinary to ensure safe execution of menu items and consistent guest experience.
Senior Quality Assurance Director Compass GroupSenior Quality Assurance DirectorBoston, Massachusetts$125,000–$130,000This role oversees brand wide food safety programs, supplier controls, operational audits, crisis management, and regulatory compliance across all jurisdictions. The director partners closely with Operations, Supply Chain, Training, and Culinary to ensure safe execution of menu items and consistent guest experience.
Director, Quality Assurance Textron IncDirector, Quality AssuranceWilmington, MA$165,700–$254,900 / yearMinimum 5 years experience in a Senior level, lean and or quality leadership role preferability in a DOD or Aerospace Environment Successful track record of talent development and performance management Ability to obtain and maintain a DoD Secret Clearance Six Sigman Green Belt, Black Belt certification preferred Strong organizational and time management skills, close attention to detail, and be able to effectively handle multiple priorities Strong computer skills, proficient with word processing, spreadsheet and presentation software, e-mail Strong analytical skills and the ability to identify trends and establish proactive corrective actions. Recruiting Company: Textron Systems Primary Location: US-Massachusetts-Wilmington Job Function: Quality Schedule: Full-time Job Level: Director Job Type: Experienced Shift: First Shift Travel: Yes, 10 % of the Time Relocation: Available Job Posting: 07/07/2026, 11:07:30 AM Job Number: 343585.
Director, Quality Assurance (Operations) Zevra Therapeutics IncDirector, Quality Assurance (Operations)Boston, MA10+ 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.
Director, Clinical Quality Assurance Seaport TherapeuticsDirector, Clinical Quality AssuranceBoston, Massachusetts$198,000–$225,000 / yearThe 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.
Director, Clinical Quality Assurance Oruka TherapeuticsDirector, Clinical Quality AssuranceWaltham, MassachusettsRemoteThis 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.
NewAssociate Director, GCP/GLP/GVP QA Rhythm PharmaceuticalsAssociate Director, GCP/GLP/GVP QABoston, MAFull timeLead or assist with GCP health authority inspections, assist clinical teams in preparation for inspections, and provide GCP compliance technical support during inspections of vendors, clinical investigator sites and Rhythm. Manage Rhythm’s QMS for Clinical QA activities, including development and management of controlled documents and training matrices, audits, CAPAs/deviations and management and approval of related documentation.
Director, GCP Quality Assurance Beeline MedicinesDirector, GCP Quality AssuranceBoston, MassachusettsLed by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.
Sr Director, QA- GxP Systems Candel Therapeutics IncSr Director, QA- GxP SystemsNeedham, MA$258,333–$280,000 / yearSystem Validation & Governance: Own all CSV (computer system validation) activities, including SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations. serve as a strategic partner across departments, while independently owning vendor oversight, computer system validation, and overall GxP system effectiveness.
Director, Clinical Quality Assurance Oruka Therapeutics IncDirector, Clinical Quality AssuranceWaltham, MARemote$213,000–$240,000 / yearRole 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.
Associate Director, Clinical Quality Assurance Kailera TherapeuticsAssociate Director, Clinical Quality AssuranceWaltham, MassachusettsPlan, coordinate, review and approve internal, external, and clinical site audits using risk-informed strategy to ensure GCP/GVP compliance in clinical studies and pharmacovigilance operations. through helping to facilitate the identification of critical data and critical data processes, and risks associated with them, establishing, monitoring and reporting out on Quality Tolerance Limits (QTLS)).
Director, U.S. Commercial QA Lead (GMP) Pharvaris NVDirector, U.S. Commercial QA Lead (GMP)Boston, MA$195,000–$225,000 / yearStrategic 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.
Director, Quality Assurance (Operations) Zevra TherapeuticsDirector, Quality Assurance (Operations)Boston, Massachusetts10+ 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.
Associate Director, GMP QA Operations Dyne Therapeutics IncAssociate Director, GMP QA OperationsWaltham, MA$160,000–$195,000 / yearRole 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.
Associate Director, GMP Quality Assurance Operations Kiniksa Pharmaceuticals International PlcAssociate Director, GMP Quality Assurance OperationsLexington, MAKiniksa 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.
Sr Director, QA- GxP Systems Candel TherapeuticsSr Director, QA- GxP SystemsNeedham, MAFull timeSystem Validation & Governance: Own all CSV (computer system validation) activities, including SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations. serve as a strategic partner across departments, while independently owning vendor oversight, computer system validation, and overall GxP system effectiveness.
NewAssociate Director, GCP/GLP/GVP QA Rhythm Pharmaceuticals IncAssociate Director, GCP/GLP/GVP QABoston, MA$160,000–$240,000 / yearLead or assist with GCP health authority inspections, assist clinical teams in preparation for inspections, and provide GCP compliance technical support during inspections of vendors, clinical investigator sites and Rhythm. Manage Rhythm's QMS for Clinical QA activities, including development and management of controlled documents and training matrices, audits, CAPAs/deviations and management and approval of related documentation.
Senior Director, Pharmacovigilance Quality Assurance Dyne Therapeutics IncSenior Director, Pharmacovigilance Quality AssuranceWaltham, MA$240,000–$280,000 / yearThe company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. This role sets the direction for PV quality systems and ensures scalable, inspection-ready operations that support high-quality regulatory submissions and continuous patient safety assurance across the portfolio.
Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU) PrileniaDirector / Senior Director, GCP Quality Assurance Lead (US/IL/EU)Europe, MassachusettsRemoteAbout 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.
Executive Director, Clinical Quality Assurance Wave Life Sciences LtdExecutive Director, Clinical Quality AssuranceLexington, MA$260,000–$350,000 / yearThis role partners closely with GMP Quality Assurance and Discovery and Development senior leaders and stakeholders to develop, implement, and continuously improve global and local GLP/GCP quality strategies that align with Wave program pipeline goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington's disease, as well as several preclinical programs utilizing our versatile RNA medicines platform.
Associate Director, Analytical Quality Assurance Vertex Pharmaceuticals IncAssociate Director, Analytical Quality AssuranceBoston, MA$156,600–$234,800 / yearAt Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. Key Duties and Responsibilities: Analytical Lifecycle Management: Serve as a Quality Assurance Subject Matter Expert for in QC domain and drive culture of quality to assure compliance with FDA, EMA, and internal SOPs.
Analytical Quality Assurance, Associate Director Vertex PharmaceuticalsAnalytical Quality Assurance, Associate DirectorBoston, MassachusettsAt Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. Analytical Lifecycle Management: Serve as a Quality Assurance Subject Matter Expert for in QC domain and drive culture of quality to assure compliance with FDA, EMA, and internal SOPs.
Director, CMC QA Korro Bio IncDirector, CMC QACambridge, MA$200,000–$240,000 / yearPosition Summary: The Director, CMC QA will be responsible for providing quality oversight and direction to Korro Bio''s vendors to ensure that drug substance, drug product, and finished product are manufactured, tested, released, and distributed in compliance with current Good Manufacturing Practices (cGMPs). Provide quality and technical input to cross-functional project teams, and review internal and external documentation including protocols, reports, test methods, specifications, master batch records, and SOPs.
Senior Director, Clinical Quality Assurance Alkermes PlcSenior Director, Clinical Quality AssuranceWaltham, MAA member of the Alkermes Quality leadership team responsible for overall Quality culture and continuous improvement of Alkermes QMS and compliance, and leads the Alkermes strategy and GXP compliance on all matters concerning Quality in the areas of; Good Laboratory Practices (GLP), Good Clinical Practices (GCPs), and Good Pharmacovigilance Practices pre and post market (GVPs). Oversee the development, implementation, and continuous improvement of clinical quality systems, harmonized GCP/GVP/GLP Policies, processes, SOPs, and governance structures collaborating closely with Clinical Department, related functions and external partners to comply with global requirements.
Associate Director, QA Manufacturing Technical Services Vertex PharmaceuticalsAssociate Director, QA Manufacturing Technical ServicesBoston, MassachusettsProvide quality and technical expertise in the investigation of deviations including OOS/OOTs, conduct thorough root cause analysis to identify underlying issues, and oversee efficient and effective implementation of corrective and preventive actions (CAPA) to prevent recurrence. The role is also responsible for building strong partnerships with internal cross-functional teams to drive compliance, monitor performance, support continuous improvement, and provide quality presence and real-time support on the manufacturing floor.
NewDirector, Quality Assurance and Regulatory Affairs Meridian Bioscience, Inc.Director, Quality Assurance and Regulatory AffairsNorth Billerica, MassachusettsEnsure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirements. At least 10 years’ experience leading in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, specifically21 CFR Part 820 Quality System Regulation , the IVD Directive 98/79 EC, as well as ISO 13485 requirements.
Senior Director, GMP Quality Assurance Karyopharm Therapeutics IncSenior Director, GMP Quality AssuranceNewton, MALead investigations into significant quality issues with focus on product impact and patient safety; escalate and manager MRB (Material Review Board) meetings; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate. Our lead therapy, XPOVIO (selinexor), is a first-in-class inhibitor of exportin 1 (XPO1) and is approved in the U.S. for adults with relapsed or refractory multiple myeloma, with approvals in more than 50 countries and territories outside the U.S. We are also exploring opportunities to evaluate XPO1 inhibition across myeloproliferative neoplasms and TP53 wild-type driven solid tumors using next-generation compounds, including eltanexor.