GCP Quality Associate Director: Investigations & CAPA Leader
Vertex Pharmaceuticals
Vertex Pharmaceuticals is hiring a GCP Quality Associate Director in Boston. The role involves overseeing quality assurance and compliance for GCP activities, including managing quality events and assisting in investigations. Candidates should possess a Bachelor's degree with at least 10 years of relevant experience. This position offers a hybrid work model and includes competitive salaries and benefits, focusing on employee wellbeing and development. #J-18808-Ljbffr Vertex Pharmaceuticals
$160.6k - $240.8k
...GENERAL POSITION SUMMARY: The Associate Director, GCP Compliance is responsible for the quality assurance and compliance activities in support... ...Quality Events including, but not limited to investigations, CAPAs, Root Cause Analysis, Effectiveness Checks)....SuggestedWork experience placementSummer workRemote workFlexible hours2 days per week$148k - $222k
...Quality Product Complaints Associate Director The Quality Product Complaints Associate Director is responsible... ...direction on complex and high-risk investigations Lead product complaint investigations... ...and requirements, including CAPA and Effectiveness Checks. Root...SuggestedContract workWork experience placementSummer workRemote workFlexible hours2 days per week$156.6k - $234.8k
...*General Summary:**The Manufacturing Process & Technical Quality Associate Director is accountable for end-to-end technical quality oversight... ...and drive standardized processes across sites.* Support investigations, preparation of specifications, CMC clinical and commercial...SuggestedWork experience placementSummer workRemote workFlexible hours2 days per week- ...building a fit-for-purpose Quality organization to support... ...Position Overview The Senior Director, Quality Assurance GCP is a key role within Hemab... ...programme, covering CROs, investigator sites, vendors, and... ...corrective and preventive actions (CAPAs) through to effective...Suggested
- Looking for a GCP Quality expert to work on implementing quality from work for our on going... ...contact for assigned vendors and investigator sites supporting clinical programs. Support... ...deviations, potential serious breaches, CAPAs, change actions, and effectiveness...Suggested
$155k - $190k
...Associate Director, Clinical Quality Assurance Waltham, Massachusetts At Kailera,... ...and ensure compliance with GCP/GVP regulations, guidelines... ...activities, including audits, investigations, and inspection readiness... ...and preventative actions (CAPA) Lead investigations...Full timeLocal areaFlexible hours$160k - $175k
Senior Manager / Associate Director, GMP Quality Location: Boston, MA (preferred; remote possible) Reporting... ...Systems & Compliance: Oversee investigations related to deviations and product quality... ...resolution, root‑cause analysis and CAPA implementation. Serve as point of...Remote workFlexible hours$185.37k - $308.95k
...Associate Director, Medical Review Lead, MSRM Who we are: At Agios... ...Reports (ICSRs) across investigational and marketed products, ensuring... ...compliance, and high-quality safety data to support pharmacovigilance... ...issues, contributing to CAPAs, and representing MSRM for...Temporary workRemote workWork from homeFlexible hours3 days per week$164.5k - $222.5k
Associate Director, Clinical Quality and Continuous Improvement Overview Provides strategic... ...to ensure compliance with GCP requirements, regulatory... ...with root cause analysis, CAPA management, and issue... ...AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach...Full timeTemporary workLocal areaRemote workFlexible hours$185.37k - $308.95k
...Associate Director, Medical Review Lead, MSRM At Agios, we are fueled... ...Safety Reports (ICSRs) across investigational and marketed products,... ...regulatory compliance, and high-quality safety data to support... ...quality issues, contributing to CAPAs, and representing MSRM for...Temporary workRemote workWork from homeFlexible hours3 days per week- ...Associate Director of Quality Assurance Summary: The Associate Director of Quality... ...and evaluate incident investigations and related Corrective and Preventive Action ("CAPA") activities and processes.... ...collaborative and proactive; a leader who can positively and productively...Temporary workFor contractorsFor subcontractorFlexible hours
- Vertex Pharmaceuticals in Boston is seeking a GMP Operational Quality Manager to support quality assurance processes and ensure... ...compliance with cGMP standards. The successful candidate will lead investigations, collaborate with business partners, and facilitate...
- ...mission is to be the global leader of professional consulting services... .... About the role As a Senior Quality Systems Engineer, you will... ...of ECI’s client's team in CAPA execution/management and Complaints... ...project team in the review, investigation, and completion of complaint...For contractorsVisa sponsorshipWork visaFlexible hours
$160k - $180k
...presentations here. About the Role Senior Manager, GCP Clinical Quality As the Senior Manager, GCP Clinical Quality reporting to the Senior Director GCP Quality Assurance, you will be... ...corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders...Work at officeFlexible hours2 days per week$166.6k - $208.26k
...Director, Global Quality Assurance, GCP/GLP Waltham, MA Zenas is a clinical-stage global... ...committed to becoming a leader in the development and... ...managing quality issues, investigations, and inspections. Additionally... ..., investigations, and CAPA's. Conduct on-site,...Remote work$160k - $180k
...class potential. About the Role As the Senior Manager, GCP Clinical Quality reporting to the Senior Director GCP Quality Assurance, you will partner with... ...report writing and follow‑up to findings, including CAPAs and communicate results to stakeholders. Provide a...Work at office2 days per week- ...commercial operations. About the Role: We are seeking a Director, Quality Assurance, GCP/GLP to join our team. We are building our Quality function... ...in conducting audits, adapting issues into effective CAPAs, and evaluating trends to mitigate risks. Ability to prioritize...Contract workTemporary workWork at officeRemote work2 days per week
- ...Associate Director, Quality The Associate Director, Quality is responsible for providing quality... ...Change Controls, Deviations, and CAPAs Ensure transfers align with regulatory... ...Systems, including deviations, investigations, CAPA's, change control, batch review...Work at officeRemote workWorldwide
$71.25k - $161.7k
...world. We are a global healthcare leader headquartered in Indianapolis,... .... Verve is seeking a Senior Associate, Quality Control Internal Operations to... ...documentation. Support OOS, OOT, investigations, deviations, change controls and CAPAs pertaining to the QC laboratory...Permanent employmentFull timeH1bWork at officeVisa sponsorshipWork visaFlexible hours$160k - $240k
...seen, and heard. How you'll make an impact: The Associate Director will act as a Quality subject matter expert for Good Manufacturing Practices... .../OOSs/OOTs and product complaints, are appropriately investigated and resolved. Collaborate cross-functionally and...Contract work$171.2k - $256.8k
...GCP & GLP QA Lead (Nonclinical & Clinical Quality Assurance) Boston, MA Tango Therapeutics... ...Massachusetts. The Director, GCP & GLP QA, reporting... ...readiness, quality events/CAPAs, and compliance... ...breaches, deviations) Lead investigations, root cause analysis,...Contract work- Regeneron Pharmaceuticals, Inc is seeking a highly motivated Associate Director to lead model-informed drug development strategies. This role emphasizes scientific depth and cross-functional leadership to guide dose selection and trial design across various therapeutic...
- Vertex Pharmaceuticals in Boston is seeking a GMP Operational Quality Senior Specialist. The role involves providing QA Analytical support for commercial product stability programs and collaborating with cross-functional teams to maintain quality compliance. The ideal candidate...
- ...Head Of Quality & Regulatory Compliance (QRC) AG Mednet is a software... ...System Validation, ICH GCP, HIPAA, GDPR, etc.), as well... ...requirements. Manage the CAPA / Quality Event program in collaboration... ...privacy and data protection, investigating potential breaches, and...Work at officeWorldwide
$168k - $252k
Associate Director, MSAT Biologics - Technical and Strategic Leader for biologic manufacturing processes. Key Responsibilities... ...Development, Manufacturing, Quality, Regulatory, Supply Chain,... ...cause analysis for deviations, investigations, and CAPAs impacting biologics...$148k - $236.5k
Pioneering Medicines: Associate Director / Director, Clinical Operations Cambridge... ..., regulatory affairs, and quality. Lead or contribute to the... ...; develop materials for investigator meetings and advisory boards... ...Maintain current knowledge of ICH‑GCP, FDA, EMA, and other...For contractors$168k - $252k
Job DescriptionGeneral SummaryThe Associate Director, MSAT Biologics provides technical and... ...between development, manufacturing, quality, and external partners, ensuring robust... ...root cause analysis for deviations, investigations, and CAPAs impacting biologics processes....Summer workRemote workFlexible hours2 days per week3 days per week$166.85k - $181.56k
...immediately to CQA management and assist/lead investigations and/or corrections of such issues. In... ...and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/... ...Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with...Contract workWork at officeLocal areaImmediate startRemote work$169.4k - $266.2k
...communication strategy and deliverables, the Associate Director, Scientific Communications Lead,... ...with internal and external opinion leaders, investigators, authors, partners, and affiliates... ..., to ensure delivery of high‑quality medical publications in a timely and...Minimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work- ...scientific communications strategy and deliverables, the Associate Director, Scientific Communications Lead, Solid Tumors proactively... ...as the primary liaison with internal and external opinion leaders, investigators, authors, partners and affiliates, and will lead the...For contractorsWork experience placementFreelanceLocal area
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