GCP QA Manager: Audits, Inspection Readiness & Quality
Green Key Resources
Green Key Resources is looking for an experienced Clinical Quality Assurance (CQA) Manager in Boston, Massachusetts. This critical role involves leading GCP quality assurance activities, developing audit strategies, and assuring compliance with global regulations. The ideal candidate will have extensive experience in quality assurance, deep knowledge of GCP regulations, and the ability to collaborate with various teams to enhance quality standards and drive continuous improvement. #J-18808-Ljbffr Green Key Resources
- ...support and expertise on R&D QA activities (GCP, GLP, GVP, GcLP) inspection readiness and preparation.... ...as a QA SME expert and manage SOP committee deliverable... ...Update and review Clinical Quality Agreements for high priority... ...Develop formal Audit Schedule for all studies...QualityFor contractorsWork experience placement
- ...seeking a Director, Quality Assurance, GCP/GLP to join our team... ...will contribute to inspection readiness initiatives and for... ...support for study teams, auditing, and inspections.... ...Responsibilities: Lead and manage quality oversight of... ...appropriately to QA Management. Assist...QualityContract workTemporary workWork at officeRemote work2 days per week
$185k - $260k
Beam Therapeutics in Cambridge is seeking an experienced Clinical Quality professional to join their Quality Team at the Associate Director / Director level. This role involves leading GCP inspection readiness strategies, supporting clinical quality activities, and...Quality- Planet Pharma seeks an experienced QA professional to provide support and expertise on R&D QA activities, including GCP, GLP, GVP, and GcLP inspection readiness. You will oversee readiness plans, update SOPs, review documents, and help develop narratives and storyboards...SuggestedFor contractors
- ...seeking an experienced Clinical Quality Assurance (CQA) Manager to lead and execute Good Clinical Practice (GCP) quality assurance... ...and implementing risk‑based audit strategies, conducting GCP... ...strong emphasis on auditing and inspection readiness . This individual will...Quality
$285k - $350k
...President, Head of Quality Assurance... ...clinical development, inspection readiness, manufacturing scale... ...product lifecycle management. The Head of Quality... ...and clinical site audits. Lead external Health... ...activities across GCP, GMP, and GPV... ...transferring into a QA role: Chemical Development...Quality$118.4k - $177.6k
...Description General Summary The Quality Manager provides oversight of... ...release by overseeing data readiness and collaborating with Contract... ...for management of QA relationships with one or more... ...improvement initiatives. Audit and Inspection Support Serve as SME responder...QualityContract workSummer workRemote workFlexible hours2 days per week- Proclinical Group is looking for a GCP Auditing Manager to lead quality assurance efforts remotely from the USA. This role involves managing audit processes, ensuring compliance with GCP standards, and conducting global audits. The ideal candidate will have a relevant...QualityRemote jobFlexible hours
- ...seeking an Associate Director, Global Quality to oversee global quality compliance across... ...leading compliance projects, ensuring inspection readiness, and embedding quality processes.... ...should have a strong background in project management and quality systems, preferably within...Quality
- ...that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information... ...at eliquent.com. Key Responsibilities Real-time Inspection Readiness Develop, manage and contribute to ongoing maturity of GMP Inspection Readiness...QualityWork experience placement
- Senior Director, GCP Quality Oversight at Bicara Therapeutics Position Overview The... ...GCP Quality Oversight candidate will manage activities related to the... ...conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify...QualityContract workWork at officeLocal area3 days per week
$252k - $269k
Alkermes is seeking a Clinical Quality Assurance Senior Leader in Boston, MA. This role involves... ...leadership and operational oversight of GCP/GLP/GVP quality programs to ensure... ...clinical sponsor activity and 8+ years in GCP management. The position offers a salary range of $2...Quality- ...(US) is seeking a Clinical Study Quality Lead to oversee quality assurance... ...operations, ensuring compliance with GCP standards. The ideal candidate will contribute to audit and quality plans, manage compliance risks, and drive inspection preparedness activities. The role...Quality
$156.6k - $234.8k
...Responsibilities Lead a Quality Operations team... ...commercial drug products. Manage QA On the Floor and QA Walkthrough... ...programs; provide GCP compliance... ...mitigation. Develop risk-based audit plans; ensure audits... ...quality improvement, inspection readiness, and regulatory/agency...QualityWork experience placementShift workDay shift- Bicara Therapeutics is seeking a Senior Director, Quality Management Systems in Boston to build and lead the company’s QMS from the ground up. This leadership role will ensure operational efficiency and compliance with GxP activities. The ideal candidate will have over...Quality
$140k - $160k
...Primary Function: The Clinical QC Manager is a Clinical Operations-... ...for conducting independent quality control (QC) assessments to... ...with study protocols, GCP, and company procedures. This... ...cross‑study trend analysis. Inspection Readiness Support Support inspection readiness...QualityWork at officeRemote workWorldwideRelocation package- ...seeking a Senior Director, Quality Management Systems (QMS), reporting to... ...efficiency, and sustained inspection readiness. As a key member of the Quality... ...closely with GMP and GCP Quality leaders to design and... ...training, risk management, audits, and Quality Management Review...QualityLocal areaRemote work3 days per week
$213.6k - $320.4k
...Senior Director, Quality Systems/... ...of the Quality Management System. The role... ...evolution ensuring readiness and sustainability... ...Partners with QA leadership and... ...standards, inspection readiness, compliance... ...(GMP and/or GCP with additional... ...operations such as audit, compliance,...QualityContract workWork experience placementSummer workRemote workFlexible hours2 days per week- ...Associate Director, R&D Quality role at BioSpace We... ...through periodic review), manages vendor quality metrics... .../leads risk‑based audits with durable CAPA follow... ...will strengthen inspection readiness, harmonize processes and... ...‑based vendor audits (GCP/GLP/GCLP as applicable...QualityWork from home
$156.6k - $234.8k
...Director, GMP Operational Quality The Associate... ...manufacturing facilities. Manages QA On The Floor and QA... ...programs providing GCP compliance interpretation... ...Develops risk-based audit plans for assigned programs... ...for proactive inspection readiness across assigned programs...QualityWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week- Vertex is seeking a Project Manager contractor to lead inspection readiness and commercial readiness initiatives within Cell and Gene Therapy... ...logs, and stakeholder communication across Quality, Regulatory, Manufacturing, QA/QC, and Supply Chain to ensure readiness for...QualityFor contractors
$252k - $269k
...Clinical Quality Assurance Senior Leader provides... ...of Alkermes GLP/GCP/GVP quality programs... ...the organization is ready for inspections, implements and manages risk-based quality systems... ...Clinical QA Senior leader who can... ...level risk assessments, audit strategy, oversight...QualityLocal areaWorldwide$160k - $187k
...Are you ready to join a team committed... ...Executive Director of Quality Assurance, the Senior Manager, Clinical... ...teams to provide GCP compliance guidance... ...external GCP audits/audit programs,... ...applicable. Support QA activities that... ...clinical inspection readiness activities...QualitySummer holidayWork at officeHome office$192.6k - $260.6k
...Director, Clinical Quality Risk & Portfolio... ...systems, audits, inspections, deviations, CAPAs... ...study-level quality management to proactive, enterprise... ...with other QA functions (including... ..., inspection readiness, and operational... ...systems supporting GCP study related activities...QualityLocal areaRemote workShift work- ...seeks a Clinical Study Quality Lead (SQL), Associate Director... ...includes developing audit plans and overseeing... ...ensuring adherence to GCP and Vertex standards. The... ...quality metrics, managing vendor relationships, and leading inspection readiness activities. A bachelor'...QualityFlexible hours
- ...Introduction We are seeking an experienced and detail-oriented Quality Control Manager to oversee and maintain the highest standards of quality... ...standards, and regulations. Conduct regular site inspections, audits, and testing of materials, workmanship, and processes. Identify...QualityFor subcontractorLocal area
$90k - $115k
...Director, Global Quality (R&D) Pay Range: $... ...standards while driving inspection readiness, vendor oversight,... ...of outsourced audits, and partner with business and QA stakeholders to... ...system builds and management that withstand the... ...Clinical Practice (GCP) standards for clinical...QualityWork experience placementRemote workWorldwideShift work- Vertex Pharmaceuticals is looking for a Senior Manager, Clinical Study Quality Lead, to provide quality oversight for clinical trials. The role encompasses GCP quality assurance, risk-based audit strategies, and compliance management. This position offers a hybrid work...Quality
- Motion Recruitment is seeking a Senior Compliance Manager to drive compliance initiatives across... ...partnering with cross-functional teams, supporting audit readiness, and strengthening compliance programs while maintaining quality practices. Ideal candidates should have over...Quality
- ...Associate Director, Clinical Program Quality Leader in Cambridge, MA. The candidate... ...clinical research programs, ensuring inspection readiness and GCP compliance. A minimum of 10 years in... ...pharmaceutical industry and strong project management skills are required. This hybrid role...QualityHourly pay
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