QA Compliance Lead: Vendor & Audit Management

Genetix Biotherapeutics Inc.

Genetix Biotherapeutics Inc. in Somerville, MA is hiring a Senior Manager of QA Compliance to lead vendor qualification, supplier oversight, and GxP audit programs in a fast-paced biotech setting.

You will develop risk-based audit strategies, manage audits of CMOs, CROs, labs, and distributors, and ensure inspection readiness while collaborating with Legal, Regulatory, and Operations. This hybrid role requires 8–10 years' QA leadership and a life sciences degree.

#J-18808-Ljbffr

Apply

Vacancy posted 4 days ago

Similar jobs that could be interesting for youBased on the QA Compliance Lead: Vendor & Audit Management in Somerville, MA vacancy

SENIOR QUALITY ASSURANCE DIRECTOR
...programs, supplier controls, operational audits, crisis management, and regulatory compliance across all jurisdictions. The... ...follow through. Supply Chain & Vendor Quality •Approves and monitors... ...Crisis & Incident Management •Leads investigations of foodborne illness...
Suggested
Local area
Remote work
Flexible hours
Shift work
Flik Hospitality Group
Boston, MA
4 days ago
Nuclear QA Program Lead Build & Govern Quality
...seeking a Quality Assurance Program Lead in Boston (Hybrid) to drive... ...will stand up an integrated QA program with a quality... ...achieving NQA-1 and ISO 9001 compliance, and run day-to-day activities... ...procedures, supplier qualification, audits, and corrective actions, reporting...
Suggested
Alva Energy, Inc
Cambridge, MA
1 day ago
Senior QA Compliance Lead - Hybrid, Quality Excellence
...Sarepta Therapeutics is seeking a Sr. Manager, QA Compliance to lead GxP quality systems and data-driven quality improvements across manufacturing... ...partnering with QA, manufacturing, MS&T, and external vendors. The role emphasizes risk-based decision making, regulatory...
Suggested
Sarepta Therapeutics
Bedford, MA
5 days ago
Senior Manager, Global Pharmacovigilance (PV) Quality Assurance
Take the lead in shaping global pharmacovigilance quality... ..., overseeing critical audit programmes, vendor quality, and regulatory compliance activities. R&D Partners is seeking a Senior Manager, Global... ...role focuses on auditing, QA operations, and supporting...
Suggested
R&D Partners
Cambridge, MA
3 days ago
Senior Nuclear QA Lead Auditor (NQA-1)
...Construction Material Testing is seeking a Lead Auditor to own the audit program within our nuclear QA framework. You will plan the annual audit schedule, lead internal audits and supplier audits with a team of auditors and technical specialists, write audit reports, and...
Suggested
Construction Material Testing
Cambridge, MA
4 days ago
Associate Director, R&D Quality — Vendor Quality & Audits
A leading biotech company in Massachusetts is seeking an experienced Associate Director, R&D Quality. This role manages vendor quality, oversees audits, and drafts Quality Agreements. The ideal candidate... ...Quality, strong knowledge of compliance standards, and excellent...
BioSpace
Cambridge, MA
5 days ago
Computerized Systems Quality Assurance Lead
$116k - $182.27k
...Quality Assurance (CS QA) Lead helps deliver on Takedas... ...and regulatory compliance of computerized systems... ...in ongoing operational management activities for global... ...global computerized system vendors and 3rd party software... ...and support during audits and inspections of TakedaIdentify...
Minimum wage
Work at office
Local area
Immediate start
Remote work
Night shift
Takeda
Lexington, MA
3 days ago
Vaccines QA Director: GCP, FDA Audits & Global Lead
...Resources Inc. seeks a Director of Quality Assurance to lead vaccine clinical support auditing and compliance for a prominent pharmaceutical client. This role... ...will have a strong background in project management and excellent communication skills to manage cross-...
Integrated Resources
Cambridge, MA
5 days ago
Senior GMP Analytical QA Lead
...Vertex Pharmaceuticals in Boston seeks a GMP QA Analytical Sr. Quality Specialist to serve as a subject matter expert in QA and compliance for the Analytical function. The role supports clinical and commercial programs and collaborates across teams to ensure rapid, accurate...
Vertex Pharmaceuticals
Boston, MA
5 days ago
Associate Director, Global Quality Risk Management
$155k - $214k
...Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence. Leading the charge in designing, implementing, and... ...Reporting to the Director of Quality Risk Auditing & Governance, you will be the primary...
Full time
Temporary work
Local area
Biogen Idec
Somerville, MA
4 days ago
Associate Director, Quality Auditing & Compliance
$188k - $230k
...The Associate Director, Quality Auditing & Compliance is responsible for leading and executing the company’s risk-... ...continuous improvement of the Quality Management System (QMS).Responsibilities:... ...of internal, external, and vendor/third-party auditsEvaluate compliance...
Full time
Work at office
Flexible hours
2 days per week
3 days per week
Ardelyx
Waltham, MA
2 days ago
Global Head of Quality Audit and External Liaison
$247.5k - $357.5k
...title: Global Head of Quality Audit and External LiaisonLocation:... ...product launches and support compliance through quality audits,... ...pragmatic leadership and change management. Fluent English. Bachelors degree... ...global supply.Power industry-leading performance by leveraging...
Full time
Remote work
Worldwide
Sanofi
Cambridge, MA
3 hours ago
Senior Director, Global Pharmacovigilance Quality Assurance Lead
$227.9k - $308.3k
...Quality Assurance Lead provides executive... ...direction for the GVP QA function and... ...long-term regulatory compliance.This role can be... ...overseeing compliance risk management, quality metrics,... ...risk-based GVP audit strategy and PV... ...processes, vendors, and delegated partners...
Full time
Temporary work
Local area
Remote work
Flexible hours
Alnylam Pharmaceuticals
Somerville, MA
3 days ago
Senior Manager, Clinical Study Quality Lead
$137.8k - $206.8k
...Summary:The Senior Manager, Clinical Study Quality Lead provides study-level... ...they are conducted in compliance with Good Clinical... ...including risk-based audit strategy, quality risk... ..., including CROs, vendors, and investigator sites... ..., hands-on GCP QA experience supporting...
Full time
Summer work
Remote work
Flexible hours
2 days per week
Vertex Pharmaceuticals
Boston, MA
1 day ago
Director of Compliance and Quality Assurance
...Massachusetts Job Description - Director of Compliance and Quality Assurance (260006PL) Job... ...statewide and departmental contract) vendor supplier diversity spend reporting,... .... Primary Responsibilities Manages and leads the SDO Compliance & Quality Assurance...
Full time
Contract work
Part time
For contractors
Work experience placement
Work at office
Flexible hours
Shift work
Commonwealth of Massachusetts
Boston, MA
3 days ago
Director, Adversarial Testing Program Leader
$171k - $320k
...build a career, KPMG provides audit, tax and advisory services... ....Responsibilities:Lead the program in conducting... ...organization's goals and risk management strategies, and stay abreast... ..., and contract and vendor oversight to ensure compliance with security requirements...
Contract work
H1b
Local area
KPMG
Boston, MA
2 days ago
QA Lead
$112.1k - $154.2k
...Description CD PROJEKT RED is looking for a QA Lead to join the Cyberpunk 2 team in our Boston Hub. In this role, you will manage a gameplay QA team within the project, adapting... ...development, production, and external QA vendors to coordinate dependencies, gameplay requests...
Full time
Casual work
Work at office
Home office
Shift work
CD Projekt
Boston, MA
4 days ago
Food Safety and Quality Assurance Manager
...Safety & Quality Assurance Manager plays a key leadership... ..., and regulatory compliance across all operations.... ...position is responsible for leading a team of FSQA... ...departments, and maintaining audit readiness. The ideal candidate... ...leadership. Oversee QA laboratory programs and...
Local area
Hirebridge
Chelsea, MA
3 days ago
Director, Clinical Quality Assurance
...hiring an Associate Director, Clinical Quality Assurance to lead GCP/GLP/GPV quality activities across clinical programs. You will manage audits, quality issues, investigations, and inspections, ensuring compliance with FDA, EU, ICH guidelines, and internal SOPs....
Work at office
Remote work
Kiniksa Pharmaceuticals
Lexington, MA
1 day ago
Director of Quality Control
...and drive phase-appropriate GMP compliance across a growing modality... ...Key Responsibilities Build and lead a high-performing QC organization... ...readiness. Grow, mentor, and manage QC staff across analytical,... ...CDMOs and external labs including vendor qualification and ongoing...
Vivid Resourcing
Cambridge, MA
3 days ago
Quality Assurance Lead, Human Services & Compliance
...seeking a Quality Assurance Specialist to oversee QA standards across programs for adults with... ...and intellectual disabilities. You will ensure compliance with DDS, MassHealth, CARF and other accrediting bodies, and lead continuous quality improvement initiatives. The...
Charles River Center
Needham Heights, MA
4 days ago
Senior Project Manager, Enterprise Quality
...General Brigham.The Senior Project Manager, reporting to the... ...Quality Team, will independently lead and manage enterprise-wide quality... ...—including Hospital Quality, Compliance, Infection Control, Risk &... ...enterprise and with external vendors/partners.Promote and model Mass...
Work at office
Remote work
Flexible hours
Shift work
Mass General Brigham
Somerville, MA
1 day ago
Senior Assurance Manager, CPA | Path to Equity Partner
$110k - $130k
...serving as a true strategic advisor Lead a diverse mix of audit, review, compilation, financial... ...expanding your own leadership, client management, and business development experience... ...reporting for quality, accuracy, and compliance Advise clients on financial...
Remote work
Jobrapido
Boston, MA
1 day ago
Senior Bridge Design & QA Lead (Hybrid)
VHB is seeking a Senior Technical Bridge/QA Engineer with 15+ years in structural design. This hybrid role involves overseeing technical design, mentoring staff, and ensuring high quality standards. The successful candidate will work on complex bridge and transportation...
VHB
Watertown, MA
5 days ago
Vice President, Head of Quality Assurance
$285k - $350k
...This individual will lead the continued... ...partners, to ensure compliance with applicable global... ...’s Quality Management System in a phase-... ...quality agreements, audit programs, and ongoing... ..., and of clinical vendors and sites through... ...into QA: Chemical Development...
Contract work
Treeline Biosciences, Inc.
Watertown, MA
2 days ago
Manager, GMP Quality
$116k - $174k
...outsourced model where compliance and inspection... ...development cycle. The Manager, Quality Assurance, will provide GMP QA oversight for Tango... ...in clinical trials Lead & manage strategic... ...Participate in GMP audits of CMOs, contract... ...laboratories, and other vendors, providing...
Contract work
Tango Therapeutics
Boston, MA
2 days ago
Associate Director, GMP Quality & Regulatory Oversight
...Director of Product Quality Assurance to lead phase-appropriate quality oversight... ...partners. The role drives risk management, investigations and release... ...oversee analytical method validation, vendor relationships, and ensure compliance with global cGMP standards #J-1880...
Beam Therapeutics Inc.
Cambridge, MA
1 day ago
Associate Director, Clinical Quality Assurance
...Associate Director, Clinical QA, providing hands-on... ...programs to ensure compliance with GCP, GLP, and GCLP... ...standards. Responsibilities: lead audits of CROs, laboratories,... ...and internationally manage clinical quality events... ...documentation support vendor qualification, oversight...
Korro Bio, Inc.
Cambridge, MA
1 day ago
Senior Director, Quality Compliance
$250k - $273k
...medicines, anchored by its lead product, ARCALYST, the first... ...a Senior Director, Quality Compliance reporting to the VP, Head... ...robust global supplier quality management program for CMOs, CROs, and critical vendors.Oversee qualification, auditing, performance monitoring,...
Work at office
Kiniksa Pharmaceuticals
Lexington, MA
1 day ago
Director, Study Quality and Compliance - Nonclinical Safety/Toxicology
$185.5k - $344.5k
...HybridThis role oversees the Study Quality and Compliance team within the Toxicology line function... ....Job DescriptionKey Responsibilities:Lead and provide strategic oversight to the... ...leading the implementation of tracking, management, and data analytics software (eg,...
Full time
Novartis
Somerville, MA
4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to QA Compliance Lead: Vendor & Audit Management. Be the first to apply!