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 Genetix Biotherapeutics Inc.
- ...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...SuggestedLocal areaRemote workFlexible hoursShift work
- 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
- A leading life sciences company in Cambridge is seeking a QA Manager to oversee quality assurance activities for commercial finished goods and manufacturing partners... .... You will act as a QA representative, ensuring compliance with regulatory standards in assembly, labeling,...Suggested
- 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...Suggested
$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...SuggestedMinimum wageWork at officeLocal areaImmediate startRemote workNight shift$160k - $180k
Senior Manager, Quality Assurance Vendor & Audit Management About Genetix Biotherapeutics At Genetix Biotherapeutics every... ...Description The Senior Manager, QA Compliance - Vendor & Audit Management is responsible for leading the Genetix's vendor qualification, supplier...Full timeContract workWork at officeRemote workFlexible hours3 days per week- ...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-...
$150k - $180k
...Quality Assurance Program Lead Location: Boston (... ...travel to project or vendor sites as required... ...and achieves ISO 9001 compliance, then keep the program... ...suppliers, perform audits, drive corrective actions... ..., and Project Management Develop the QA Program Manual and user...For contractors$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 timeTemporary workLocal area$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 timeTemporary workLocal areaRemote workFlexible hours$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 timeRemote workWorldwide$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 timeWork at officeFlexible hours2 days per week3 days per week$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 timeSummer workRemote workFlexible hours2 days per week- ...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, microbiology... ...and external labs including vendor qualification and ongoing...
- ...owns Ketryx's Quality Management System (QMS), Information... ..., scalable, and audit-ready while helping the... ...Because Ketryx builds compliance software for regulated... ...and SOC 2 programs. Lead AI governance: Own AI policies... ...guidance. Lead the QA/RA consulting team: Staff...Full timeWorldwide
$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 workH1bLocal area- The QA Manager serves as the Quality Assurance representative for commercial finished goods... ...packaging, and serialization to ensure compliance with internal standards and global regulatory... ...manufacturing sites. Experience leading or supporting root cause analysis, investigations...Contract work
- ...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
- Apnimed, based in Cambridge, MA, is seeking a Senior Manager, GMP Quality Assurance to lead quality oversight across external manufacturing and testing partners... .... The role reports to the Associate Director, GMP QA and collaborates with Manufacturing, CMC, Regulatory, and...
$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 timeCasual workWork at officeHome officeShift work- ...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...
- ...Inc. seeks a Quality Assurance Program Lead to stand up and run a comprehensive QA program for a first‑of‑a‑kind energy project... ...procedures, qualify suppliers, perform audits, and manage corrective actions to ensure regulatory compliance and safety‑critical quality. You will...
$60 - $80 per hour
...Job Title: Quality Assurance Manager Job Description This role leads and supports quality assurance and quality... ...plays a key role in ensuring GMP compliance, maintaining a strong quality... ...experience in quality assurance (QA) and quality control (QC) roles, supporting...Full timeContract workTemporary workMonday to Friday- 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...
$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$79.56k - $115.72k
...Job Summary The Senior Project Manager, reporting to the... ...Quality Team, will independently lead and manage enterprise‑wide quality... ...—including Hospital Quality, Compliance, Infection Control, Risk & Safety... ...enterprise and with external vendors/partners. Promote and model...Work at officeRemote workFlexible hoursShift work$266k - $344k
...delivering category-leading precision therapies to... ...documented, and reported in compliance with applicable... ...serves as a senior QA leader and strategic... ...Pharmacovigilance, Data Management, Biostatistics, and... ...management, CRO and vendor oversight, audit strategy, inspection...Contract workFor contractorsWork at officeLocal areaNight shift2 days per week$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$148k - $180k
...The Senior Quality Operations Manager provides day-to-day Quality... ...external partners and ensures compliance with company standards, Quality... ...partner qualifications, audits, quality governance meetings,... ...firms, or recruiters or similar vendors. Any such unsolicited resume...Full timeContract workWork at officeFlexible hours2 days per week3 days per week- ...Reference26-01975Remote50% Remote Job Profile Summary: The Vendor Quality Management Manager proactively assesses vendor risk in GMP/GDP areas and... ...on, manage, and mitigate vendor risk to acceptable levels. Leads and/or participates in process and system improvement...Remote work
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