Senior Manager, GCP Quality Assurance
$160k - $180kScorpion Therapeutics
Senior Manager, GCP Clinical Quality (Hybrid) Responsibilities Perform internal/external audits to ensure compliance with GCP/GVP regulations and guidelines. Conduct GCP/GVP audit activities (prep, execution, report writing, and follow-up), including CAPAs; communicate results to stakeholders. Support regulatory authority inspections and assist with GxP inspection readiness. Lead quality oversight for clinical study start-up, execution, and close-out in line with GCP/GVP. Assist in preparation for health authority inspections, suppliers, and/or clinical sites. Oversee clinical compliance and quality within cross-functional study teams. Improve/refine a risk-based GCP compliance approach globally. Support Quality Management System (QMS), including QA review/approval of deviations, CAPAs, and change controls. Draft, review, and approve policies, procedures, and work instructions. Qualifications / Required Bachelor’s degree in a scientific discipline. 8+ years in Quality Assurance or related role in pharma/biotech. Strong understanding of clinical trials and pharmacovigilance reporting. Strong understanding of FDA/EMA/ICH Health compliance requirements. Experience leading/conducting internal and external QA audits using risk-based audit plans. Experience supporting regulatory agency inspections; writing/reviewing SOPs. Knowledge of GCP and GVP (preferred: GLP). Experience with QMS (Veeva preferred). Skills / Attributes Excellent verbal/written communication; strong independent and collaborative work in a matrix environment. Analytical/problem-solving skills; ability to adapt to changing priorities. Strong planning/organization/time management. Compensation Base pay range: $160,000–$180,000 annually, plus equity/bonus/benefits. Application instructions None provided. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Manager, GCP Quality Assurance in Cambridge, MA vacancy
$160k - $180k
...OP‑3136, is a potent KAT6 inhibitor with best‑in‑class potential. About the Role As the Senior Manager, GCP Clinical Quality reporting to the Senior Director GCP Quality Assurance, you will partner with Clinical Development/Operations, Pharmacovigilance and Safety to actively...SeniorWork at office2 days per week- Olema Oncology is seeking a Senior Manager for GCP Clinical Quality to ensure compliance and improve processes in clinical trials. This position will... ...should have at least 8 years of experience in Quality Assurance and a Bachelor's degree in a scientific discipline. The...Senior
$250k - $290k
Proclinical Group is seeking a Senior GCP Quality Assurance Lead to oversee quality assurance for clinical development initiatives in Boston. This role requires extensive experience in GCP QA within biotech or pharmaceutical environments. The successful candidate will...Senior- Scorpion Therapeutics is searching for a Senior Manager in GCP Clinical Quality to oversee quality compliance and lead audit activities. The ideal candidate... ...regulations while supporting clinical trial quality assurance. Responsibilities include conducting audits, preparing...Senior
$250k - $290k
Senior GCP Quality Assurance Lead - Permanent - Boston - Remote Take the lead in delivering world‑class QA across clinical development and advancing... ...ensure quality standards are met. Oversee eTMF quality, manage protocol deviations and GxP non‑conformances, and drive...SeniorPermanent employmentRemote work$160k - $187k
...Essential Job Functions Reporting to the Executive Director of Quality Assurance, the Senior Manager, Clinical Quality Assurance (CQA) is responsible for... ...partnerships with clinical study teams to provide GCP compliance guidance and advice across assigned clinical programs...SeniorSummer holidayWork at officeHome officeKura Oncology, Inc.
Boston, MA4 days ago- ...About the role The Director/Sr. Dir, GCP Quality Assurance is Prilenia's primary quality lead for... ...influence cross‑functional teams and senior leadership. Roles and Responsibilities... ...execution, aligning on standards, and managing issue escalation. Oversee eTMF quality...SeniorFull timeRemote workFlexible hours
- Responsible for support of phase-appropriate Monte Rosa Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality... ...Support the identification, assessment, documentation, and management of GCP quality events, including deviations, potential...
- Responsibilities Support phase-appropriate Monte Rosa Quality GCP/GCLP activities and provide GCP quality oversight for ongoing quality... ...supporting clinical programs. Identify, assess, document, and manage GCP quality events, including deviations, potential serious breaches...
- ...products, modalities, and geographies. Align Quality Systems with global regulatory... ...supervisory/leadership roles. GMP and/or GCP operational/quality oversight experience... ...preclinical, clinical, and CMC with quality/risk management principles. Process improvement (Lean, DMAIC...Senior
$254k - $295k
...integrated QMS to support all GxP activities. Partner with GMP and GCP Quality leads to build practical, fit-for-purpose processes. Lead the... ..., CAPA, change control, document control, training, risk management, audits, and Quality Management Review (QMR). Ensure systems...Senior- ...knowledge of competition and the factors that differentiate them in the market. Roles and Responsibilities Business Process Management Systems (e.g. Quality Management Systems, Integrated Management Systems). Work to develop, implement, and monitor overall process mapping...SeniorRelocation package
$265k - $300k
A biopharmaceutical company is seeking an Executive Director, Clinical Quality Assurance to lead QA operations focused on GCP, GPvP, and GLP compliance. The ideal candidate will have extensive experience in regulatory practices, strong problem-solving skills, and the ability...SeniorRemote job$160k - $180k
Olema Oncology is seeking a Senior Manager for GCP Clinical Quality to oversee compliance and audit functions within clinical trials. This hybrid role... ...have at least 8 years of relevant experience in Quality Assurance, excellent communication skills, and a proven track...Senior$124.63k - $179.22k
The Manager/Sr. Manager Training & Quality Systems will report to the Director Quality Systems and be responsible for the GxP Quality Training program... ...strong relationships with partner groups who support GLP, GCP and GMP activities to identify, enhance and support...Senior$213.6k - $320.4k
## Senior Director, Quality Systems/QMSApplylocations: Boston, MAtime type: Full timeposted on: Posted... ...and effectiveness of the Quality Management System. The role is instrumental in promoting... ...oversight experience (GMP and/or GCP with additional breadth preferred). Experience...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week- Healx is looking for a part-time Senior QA Auditor to lead quality assurance and compliance activities. You will work closely with the Global Head of Clinical Development, ensuring that processes meet GCP and GMP standards while collaborating with various teams in the company...SeniorPart timeFlexible hours
- ...Pharmaceuticals Inc (US) is seeking a Clinical Study Quality Lead to oversee quality assurance for clinical trial operations, ensuring compliance with GCP standards. The ideal candidate will contribute to audit and quality plans, manage compliance risks, and drive inspection...Senior
- Green Key Resources is seeking a Senior Manager, Supply Chain Quality in Boston, MA. This role involves implementing a Supply Chain Quality strategy, overseeing supplier and production quality initiatives, and managing a team of Quality Engineers. Candidates must have...Senior
$252k - $269k
Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials... ...ready for inspections, implements and manages risk-based quality systems,...SeniorLocal areaWorldwide- Keepmoat Limited is seeking a Senior Site Manager for their Cambridge location. The successful candidate will manage site activities, ensuring production, quality, and cost control while adhering to health and safety standards. The ideal candidate will have a passion for...SeniorPermanent employmentFull time
- Merck in Boston is seeking a Clinical Quality Operations Manager to ensure the highest quality in clinical trials through robust management strategies... ...years in clinical research and a profound understanding of GCP, this role requires strong project management and...SeniorRemote job
$130k - $160k
...our site in Norfolk, Virginia Site Quality leader and Management Representative responsible for... ..., and lead a high-performing quality assurance and quality control (QA/QC) team, fostering... ...hourly production employees through senior management. Must possess excellent...SeniorHourly payWork experience placementFlexible hoursZimmer Biomet
Boston, MA2 days ago- Vertex Pharmaceuticals is seeking a Clinical Study Quality Lead, Associate Director in Boston to oversee advanced quality assurance in clinical trials. Responsibilities include managing compliance with GCP standards, risk management, and coordinating with multiple stakeholders...Senior
$99.47k - $144.64k
...means to be part of Mass General Brigham. Job Summary The Senior Manager, Quality and Safety is responsible for leading the local execution of... ...Serve as the senior local site manager responsible for Quality Assurance and Performance Improvement (QAPI) planning, documentation,...SeniorFull timeTemporary workWork at officeLocal areaRemote workShift work- ...Senior Supervisor At Boston Scientific, we'll give you the opportunity... ...will support the Global Quality Distribution Product Controls... .... Partner with the manager to establish and maintain goals... ...a quality systems or quality assurance role Minimum of 2 years' experience...SeniorWork at officeLocal area3 days per week
Intracept by Boston Scientific
Boston, MA5 days ago - ...commercial operations. About the Role: We are seeking a Director, Quality Assurance, GCP/GLP to join our team. We are building our Quality function... ...of two onsite days per week. Responsibilities: Lead and manage quality oversight of the Company’s GLP programs, including the...Contract workTemporary workWork at officeRemote work2 days per week
Xenon Pharmaceuticals Inc.
Needham Heights, MA2 days ago $212k - $333.19k
...Job Description About the Role As the Senior Director, Head of Clinical Program Quality & Excellence (TAU), you will drive a risk-based quality management approach across the Therapeutic Area... ...across clinical programs Lead global GCP inspection strategy, including submission...SeniorMinimum wageFull timeTemporary workLocal areaWorldwide$260k - $320k
Beam Therapeutics in Cambridge is seeking a Senior Director of Product Quality Assurance who will oversee GMP compliance and quality support for external... ...biotech sector, with extensive experience in quality management and CDMO oversight. Competitive salary range between...Senior$245k - $335k
A biopharmaceutical company in Cambridge is seeking a Senior Director of Global Quality Control. The role involves leading the global QC function across an outsourced model, ensuring compliance with regulatory standards, and providing strategic oversight for QC activities...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Manager, GCP Quality Assurance. Be the first to apply!
Related searches
- global quality manager Cambridge, MA
- director quality assurance Cambridge, MA
- quality manager Cambridge, MA
- corporate quality manager Cambridge, MA
- director of quality Cambridge, MA
- quality manager medical devices Cambridge, MA
- director of quality & patient safety Cambridge, MA
- quality manager healthcare Cambridge, MA
- senior manager quality engineering Cambridge, MA
- director quality assurance regulatory affairs Cambridge, MA