Remote Global GCP QA Lead: Inspection Readiness & Audits
Takeda
- Remote job
Takeda is seeking a GCP Quality Assurance Lead to oversee global clinical research programs, focusing on inspection readiness and compliance across oncology, vaccines, plasma-derived therapies, and medical marketed products. Responsibilities include developing risk-based audit strategies, auditing sites, vendors and systems, leading investigations into GCP breaches, and coordinating regulatory inspections; regular updates to senior management. #J-18808-Ljbffr Takeda
- ...Director, Pharmacovigilance Quality Assurance to lead PV QA activities across development and post-... ...role emphasizes risk-based QA programs, audits of PV providers and internal processes, audit reporting, inspection readiness, CAPA effectiveness, and PV guidance across...Remote work
$266k - $344k
...delivering category-leading precision... ...Senior Director, GCP Quality Assurance... ...company policies, and global GCP standards while... ...continuous state of inspection readiness. The Senior Director... ...as a senior QA leader and strategic... ...vendor oversight, audit strategy, inspection...SuggestedContract workFor contractorsWork at officeLocal areaNight shift2 days per week- ...Sr. Director, Quality Assurance to lead global clinical QA strategy and a worldwide QA team. This... ...VP, Quality & Compliance and drives inspection readiness, metrics, CAPA management, and QMS... ...communication skills. Position offers remote work flexibility for US-based work....Remote jobWorldwide
$227.9k - $308.3k
...Senior Director, Global... ...Quality Assurance Lead provides executive... ...direction for the GVP QA function and provides... ..., and inspection-readiness capabilities to... ...arrangement, or remotely within the United... ...risk-based GVP audit strategy and PV... ...working knowledge of GCP interfaces is...Remote workFull timeTemporary workLocal areaFlexible hours$81.15k - $137.95k
...seeking a Construction QA/QC Lead to assist Los Angeles... ...quality and accuracy of inspections, cost estimations,... ...formatting to create client-ready deliverables. Ability... .... Other Job Details: Remote position with possible... ...at ICFICF is a global advisory and technology...Remote workFull timeContract workFor contractorsWork experience placementWork at office- ...a Director of Quality Assurance to lead vaccine clinical support auditing and compliance for a prominent pharmaceutical... ...extensive experience in GCP and quality oversight for clinical... ...skills to manage cross-functional teams and external inspections. #J-18808-Ljbffr...
- ...seeking a Senior Quality Lead in Pharma... ...Quality (PDQ) to develop QA strategies and lead audits for post-approval products... ...with potential remote options. The role requires strong GCP knowledge, device/CSV... ...manage regulatory inspections across global teams. #J-18808-Ljbffr...Remote work
- Proclinical seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to lead quality oversight of global... ...from Cambridge, MA, with remote engagement across... ...focuses on GVP compliance, audit programs, inspection readiness, and cross-functional collaboration...Remote job
$145k - $170k
...biologics. Arrowhead is leading the field in bringing the... ...for the company's global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs by overseeing inspection readiness, regulatory inspection management... ..., internal quality audits, and partner audit activities...Work at office- ...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.... ...CROs, labs, and distributors, and ensure inspection readiness while collaborating with Legal, Regulatory...
$247.5k - $357.5k
Job title: Global Head of Quality Audit and External LiaisonLocation: Remote, USAbout the JobThe team vision is... ...audits, regulatory inspections, regulatory surveillance... ...Good Clinical Practice (GCP), Good Clinical... ...supply.Power industry-leading performance by leveraging...Remote workFull timeWorldwide- ...Clinical Quality Assurance professional to oversee GCP compliance for global clinical programs across multiple units, ensuring inspection readiness and timely investigations. You will define risk-based audit strategies, lead pre-approval inspections, and communicate...
- Take the lead in shaping global pharmacovigilance quality excellence, overseeing critical audit programmes, vendor quality, and regulatory... ...role focuses on auditing, QA operations, and supporting... ...metrics. Support PV/PMS inspection readiness and inspection management....
$247.5k - $357.5k
...Job title: Global Head of Quality Audit and External Liaison ~ Location: Remote, US About the Job The... ...quality audits, regulatory inspections, regulatory... ...Good Clinical Practice (GCP), Good Clinical Laboratory... .... Power industry-leading performance by...Remote workFull timeWorldwide- ...Leading the implementation and continuous improvement of a compliant... ...System, the full-time remote Quality Assurance Director will... ...regulatory compliance, audit readiness, and quality operations while... ...quality representative during FDA inspections and audits, overseeing all...Remote workFull time
- ...strategic Director of Quality Systems and Compliance to lead PQS, audits, documentation, and global regulatory readiness. This role partners across functions to... ...improvement, oversee CAPAs, and lead end-to-end inspection readiness for regulatory and customer audits, while...
- ...Validation (CQV) Lead is a highly mobile... ...Manufacturing Expansion & Readiness, the role provides... ..., and inspection-readiness activities... ...internal or customer audits related to facility... ...part of a unique, global, interdisciplinary... ...have hybrid and remote employees located...Remote workFull timeFor contractors
- ...JCW Group client in Bucks County, PA seeks a QA Operations Manager to lead day-to-day Quality Assurance operations at a pharmaceutical manufacturing... ..., change controls, and batch record review with a focus on inspection readiness and quality improvement. #J-18808-Ljbffr...
- ...Cabaletta Bio is seeking an Associate Director, GCP Compliance to design and drive a risk-based QMS aligned... ..., vendor quality, and TMF health, enabling inspection readiness across GxP functions. This role can be remote, hybrid, or based in Philadelphia, PA headquarters...Remote work
- ...Regeneron is seeking a Director of Data Management Quality, Inspection Readiness, and Process Excellence to lead standardized quality systems across Data Management.... ...demands strategic leadership, robust governance, global regulatory awareness, and the ability to drive...
$130.9k - $277.2k
...storage devices. The Global Manager of Quality Assurance... ...Quality Assirance (QA) practices, and... ...contractor quality management, inspection readiness, commissioning quality... ...across all regions.Lead the development of... ...Conduct global quality audits, maturity assessments,...Ongoing contractFor contractorsWork at officeLocal area$90k - $120k
...itself can prove fatal or lead to serious conditions,... ...Senior Specialist, Global QMS will help... ...and lead the internal audit program, supplier management program, and inspection readiness. This role will support... ...permitted by law. For remote-based positions, this...Remote workFull timeLocal area- ...Clinical Quality Assurance Lead to oversee global clinical research... ...divisions. You will drive inspection readiness, strategic quality guidance, and GCP compliance across trials. Remote in Massachusetts with ~30... ...will develop risk-based audit strategies, manage site and...Remote job
$249.97k - $388.13k
...Remote Full time R12983 Job Summary... ...Director of R&D Global Quality to join... ...responsible for leading a global team focused... ...affiliates are inspection ready, oversee... ..., lead the R&D audit program, engage... ...develop a team of QA professionals,... ...sustained GCP/QSR compliance....Remote workFull timeContract workTemporary workLocal areaWorldwideFlexible hours$165k - $230k
Associate Director, Global Quality and Compliance Excellence BioSpace -... ...external agency regulations to lead preparedness for regulatory inspections and audits at AbbVie sites across the global... ...due diligence plans, inspection readiness plans, audit observations and responses...Full timeTemporary workLocal area- ...QA Operations LeadTelix Pharmaceuticals is a dynamic... ...oriented QA Operations Lead to join our... ...regulatory submissions and inspections.Lead QA Operations as a... ...being a part of a unique, global, interdisciplinary team... ...medicine. We have hybrid and remote employees located all...Remote workImmediate start
$164k - $205k
...Revolution Medicines is a global, commercial-state oncology... ...The Opportunity: Lead GxP internal audits and external audits including... ...of anticipated regulatory inspections (including those at contracted... ...data. #LI-JC1 #LI-Remote The base pay salary range...Remote workFull timeWork at officeLocal areaImmediate startWorldwideFlexible hours$137.8k - $206.8k
...Clinical Study Quality Lead provides study-... ...Practice (GCP), applicable global regulations, study... ...including risk-based audit strategy, quality... ...analysis, and inspection readiness. The role partners... ...direct, hands-on GCP QA experience... ...eligible for a fully remote work arrangement....Remote workFull timeSummer workFlexible hours2 days per week$45 - $50 per hour
...Job Title: QA Technical Lead Location: Novato, CA Type: Contract... ...Model: Hybrid - onsite and remote Responsibilities Lead... ...compliance with current and evolving global health authority... ...Provide SME support to site inspections, global inspections, and related...Remote workContract workLocal area- ...Reserve network across 700+ locations. The role requires SME-level expertise in MILCON and R&M projects, QA inspections, RFIs, and submittals reviews. The position is remote with up to 50% travel nationwide. Candidates must hold an active Secret clearance and a Bachelor’s...Remote work
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