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.
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.
NewDirector 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.
Associate Director / Director, Clinical Quality Assurance Beam TherapeuticsAssociate Director / Director, Clinical Quality AssuranceCambridge, MA$185,000–$260,000 / yearReporting 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.
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.
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.
Associate Director / Director, Clinical Quality Assurance Beam Therapeutics IncAssociate Director / Director, Clinical Quality AssuranceCambridge, MA$185,000–$260,000 / yearReporting 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.
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.
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.
NewDirector, 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.
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.
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, 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)).
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, 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.
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.
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.
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.
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.
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.
Senior Director, Manufacturing Technical Sciences Quality Assurance (Hybrid) Vertex PharmaceuticalsSenior Director, Manufacturing Technical Sciences Quality Assurance (Hybrid)Boston, MassachusettsThe role will lead a team of process and analytical QA personnel and closely partner with operational stakeholders to participate in Cell & Genetic therapies projects, quality oversight of technical change management from initiation to implementation and closure, and associated governance to meet business, regulatory and operational requirements. The Senior Director, Manufacturing Technical Sciences QA is accountable for end-to-end technical quality oversight of cell and genetic program throughout clinical development, commercialization, product launch and post approval lifecycle management activities.
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.
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.
Director, Quality Assurance and Regulatory Affairs Meridian BioscienceDirector, Quality Assurance and Regulatory AffairsNorth Billerica, MAEnsure 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.
Associate Director, QA Manufacturing Technical Services Vertex Pharmaceuticals IncAssociate Director, QA Manufacturing Technical ServicesBoston, MA$156,600–$234,800 / yearProvide 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.
Associate Director, Product Quality Assurance Beam TherapeuticsAssociate Director, Product Quality AssuranceCambridge, MA$185,000–$225,000 / yearWorking closely with the assigned PQLs, the role supports consistency and quality of content and product strategy across the CMC spectrum including review of CMC technical content provided for global clinical and commercial regulatory submissions as well as associated quality records. 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.
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, Product Quality Assurance Beam Therapeutics IncAssociate Director, Product Quality AssuranceCambridge, MA$185,000–$225,000 / yearWorking closely with the assigned PQLs, the role supports consistency and quality of content and product strategy across the CMC spectrum including review of CMC technical content provided for global clinical and commercial regulatory submissions as well as associated quality records. 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.
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.
Senior Director, GMP Quality Assurance Karyopharm Therapeutics Inc.Senior Director, GMP Quality AssuranceNewton, MassachusettsLead 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.
Senior Director, Product Quality Assurance, Cambridge Beam TherapeuticsSenior Director, Product Quality Assurance, CambridgeCambridge, MA$260,000–$320,000 / yearBeam'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. The Senior Director, Product Quality Assurance, Cambridge (PQA) will be responsible for creating/monitoring and maintaining phase appropriate levels of compliance in all of our CDMOs/external partners.
Senior Director, Product Quality Assurance, Cambridge Beam Therapeutics IncSenior Director, Product Quality Assurance, CambridgeCambridge, MA$260,000–$320,000 / yearBeam'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. Position Overview: The Senior Director, Product Quality Assurance, Cambridge (PQA) will be responsible for creating/monitoring and maintaining phase appropriate levels of compliance in all of our CDMOs/external partners.
Associate Director, Clinical QA Alkermes PlcAssociate Director, Clinical QAWaltham, MAThis position will: Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to: Audits of clinical vendors, clinical sites and clinical documents that will be submitted to regulatory authorities. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Director Quality Assurance Alnylam Pharmaceuticals IncDirector Quality AssuranceCambridge, MA$192,600–$260,600 / yearStrong leadership, communication, and stakeholder management skills, with the ability to influence across all organizational levels and partner effectively with cross-functional teams, including Clinical Operations, Regulatory Affairs, Data Management, Digital/Systems, and external vendors. This role is responsible for identifying emerging quality signals, systemic compliance risks, and operational trends across studies, vendors, computerized systems, audits, inspections, deviations, CAPAs, and quality metrics.
NewDirector of Blockchain Assurance Technology Wolf & Company, P.C.Director of Blockchain Assurance TechnologyBoston, Massachusetts$175,000–$200,000 / yearFull timeIn this role, you will work at the intersection of blockchain technology and assurance, partnering closely with assurance professionals, blockchain subject matter experts, engineers, and software providers to deliver scalable, high-quality, and technically sound assurance solutions across a diverse range of blockchain protocols and platforms. Overview: As our Digital Asset Assurance practice continues to grow in both complexity and sophistication, Wolf is seeking a Director of Blockchain Assurance Technology to join our growing and well-established national firm.
Chief of QA & Compliance Commonwealth of MassachusettsChief of QA & ComplianceBraintree, MAMINIMUM ENTRANCE REQUIREMENTS: Applicants must have at least (A) six (6) years of full-time or, equivalent part-time, professional, administrative, supervisory, or managerial experience in business administration, business management, public administration, public management, clinical administration or clinical management of which (B) at least two (2) years must have been in a supervisory or managerial capacity or (C) any equivalent combination of the required experience and substitutions below. The Chief of Quality Assurance and Compliance is a senior leadership role responsible for developing, implementing, and maintaining the Commission's quality management system, regulatory compliance framework, internal auditing procedures, and document lifecycle control.
Associate Director Quality Assurance Alnylam Pharmaceuticals IncAssociate Director Quality AssuranceCambridge, MA$164,500–$222,500 / yearPartners closely with stakeholders across Development, clinical study teams, and Quality teams to drive sustainable quality outcomes through metrics, trend analysis, and root cause analysis, strengthening process effectiveness, enhancing compliance, and enabling consistent issue management across studies. Serves as the primary QA partner across clinical development activities by providing oversight of process adoption and compliance, contributing to operational process improvements, and leading enterprise and multi-study issue management.
NewSenior Director of Quality BRIDGEWELL INCSenior Director of QualityPeabody, MABridgewell strengthens communities by providing an unmatched range of social and human services that empower people with disabilities and other life challenges to live safe, self-directed, and productive lives. Identify internal and external talent for key open positions within their areas of responsibility and help direct reports build a strong talent pipeline and succession planning through internal and external recruitment.
NewDirector of Clinical Quality and Resident Care (RN license required) Rogerson BrandDirector of Clinical Quality and Resident Care (RN license required)Boston, MassachusettsServe as a clinical resource to executive leadership on resident care, clinical operations, healthcare trends, and best practices for Resident Care, Memory Care, and Adult Day Health programs. · Partners with Executive Directors, Directors of Nursing, Nurse Managers, and Clinical Care Coordinator to promote clinical excellence, operational consistency, and high-quality resident outcomes.
Director of Quality & Population Health Signature HealthcareDirector of Quality & Population HealthBrockton, MACollaborate with Department Chiefs and operational leadership on improving ambulatory quality of care and patient safety, including initiatives related to performance in Value Based Care contracts. Under the leadership of the President of Signature Medical Group, participates in long-range planning, development of ambulatory goals, strategic plans and objectives, as well as personnel, resources, and equipment needs and decisions.
Director of Quality CatalentDirector of QualityChelsea, MassachusettsDemonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience; The anticipated salary range for this position in Massachusetts is $168,750-$257,800. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
NewDirector of Quality Engineering - Growth and Corporate Functions Segment Humana IncDirector of Quality Engineering - Growth and Corporate Functions SegmentMARemote$156,600–$215,400 / yearWork at Home Requirements: To ensure Home or Hybrid Home/Office employees' ability to work effectively, the self-provided internet service of Home or Hybrid Home/Office employees must meet the following criteria: At minimum, a download speed of 25 Mbps and an upload speed of 10 Mbps is required; wireless, wired cable or DSL connection is suggested. Decisions are typically related to the implementation of new/updated programs or large-scale projects for the function and supporting technical/operational procedures and processes, and implements strategic plans, drives goals and objectives, and improves performance.