GMP QA & Compliance Leader (Director)
Climb Bio
Climb Bio, a clinical-stage biotechnology company in Wellesley, MA, seeks an Associate Director/Director, GMP QA & Compliance to lead quality operations and oversee global clinical supply through regulatory submission readiness. Reporting to the VP, Head of Quality, you will build and develop the GMP QA program, manage DS/DP/IP labeling, coordinate with EU/ex-US Qualified Person, and partner with CMC, Regulatory Affairs, and external providers to ensure compliant, scalable quality systems for #J-18808-Ljbffr Climb Bio
$158k - $200k
Associate Director/Director, GMP QA & Compliance About Climb: Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients... ...Phase 3 supply and, ultimately, commercial launch. As a leader within the Quality organization, the successful candidate...SuggestedContract workTemporary workWork at officeLocal area- RoslinCT US in Hopkinton, MA, seeks a Principal, QA - Quality Systems to provide QA oversight of Quality Systems and Computer System... ...procedures, and training content for computerized systems within a GMP environment. The ideal candidate has extensive QA experience in...Suggested
$210k - $235k
Jade Biosciences is hiring a Director of GMP Quality Assurance. This remote role, preferably based on the U.S. West Coast, provides QA support throughout the company’s product pipeline... ...and be proficient in regulatory compliance. The role includes leading quality oversight...SuggestedRemote jobContract work- Mariana Oncology is seeking a Senior QA Specialist for Radioligand GMP Manufacturing Operations. The role focuses on ensuring compliance with quality standards in the production of radiopharmaceuticals, supporting QA activities, and leading investigations. The ideal candidate...Suggested
- Replimune is seeking a Director of Quality Systems in Framingham, MA to lead the development... ...of quality systems ensuring compliance with US and international regulations. This... ...The ideal candidate will have 10+ years in QA/QS within the pharmaceutical industry, experience...Suggested
- ...and gene therapy CDMO seeking a Principal, QA - Validation to oversee validation activities for facilities and equipment in a GMP environment. The role involves review and approval... ...with cross-functional teams to ensure compliance and quality culture. The ideal candidate...
- ...Senior IT Business Analyst, located in Lexington, MA, to support GLP/GMP systems. This role focuses on business analysis and IT systems for quality assurance and regulatory affairs, ensuring compliance and data integrity within a GxP environment. The position involves...
$129k - $156k
...their Canton, Massachusetts facility. In this pivotal role, you will lead all EH&S programs, ensuring regulatory compliance and safety management within a GMP manufacturing environment. You will harness your extensive EH&S experience and strong knowledge of regulatory...$129k - $156k
...of Environment, Health & Safety to lead EH&S programs at their GMP vaccine manufacturing site. The role requires a bachelor's degree... .... This managerial position plays a crucial role in ensuring compliance with regulations like OSHA and EPA while fostering a proactive...- Sanofi in Framingham, MA is seeking a Head of Quality Compliance to oversee GMP activities and compliance programs across site operations including Framingham Biologics, Biosurgery, and Northborough. The role leads a team to ensure readiness for inspections and drives continuous...
- • Support the Head of QA with oversight of Verastem Quality Systems and QA activities in accordance with... ...commercial and clinical stage operations • Drive compliance with current regulations and oversight of external GMP Quality operations at partner and CMO sites • Help...Flexible hours
- Novartis Group of Companies in Cambridge, MA seeks a Director to oversee the Study Quality and Compliance team within Preclinical Safety. You will drive GLP compliance, manage data for internal and external toxicology studies, and implement software to track study information...
- A major IT staffing company is seeking a Quality Compliance Investigator to manage and lead investigations into GMP operations. The candidate will support internal and external audits, ensure compliance with CGMP standards, and track corrective actions effectively. With...
- Flik by Compass Group is seeking a Food Safety & Quality Assurance Director to oversee brand-wide programs across multiple locations. You will ensure food safety, sanitation, and product quality, partnering with Operations, Supply Chain, Training, and Culinary to maintain...
- ...vendor oversight, CSV, and GxP system effectiveness, reporting to the SVP of Quality. The role requires 10+ years in biotech/pharma QA, deep knowledge of GxP and Part 11, and cross-functional collaboration across QA, Clinical Ops, CMC and Research. #J-18808-Ljbffr Candel...Remote work
- Vertex Pharmaceuticals Inc. seeks a CMC Quality Compliance Director to oversee inspection readiness and comprehensive quality compliance across internal and external GMP sites. This role provides technical leadership for governance and continuous improvement in quality...
- Monte Rosa Therapeutics, Inc. seeks a Senior Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities. This role includes GCP quality oversight of ongoing activities supporting pre-clinical and clinical programs, with 75%...
- Scorpion Therapeutics seeks a CMC Statistics Director (Scientific Fellow) to provide strategic and technical leadership across the product lifecycle, including process development, analytical development, manufacturing, and regulatory submissions. You will establish a...
- Bausch Health Companies Inc. is seeking a Senior Director of Advertising & Promotion - Regulatory Affairs to lead and participate in... ...claims, monitors regulatory trends, and collaborates with Legal, Compliance and Medical Affairs to drive #J-18808-Ljbffr Bausch Health...
- ...leading frozen foods manufacturer, seeks an Associate Director of Quality Assurance & Food Safety to lead daily QA operations in a USDA FSIS-regulated RTE... ..., R&D, Sanitation and Regulatory teams to ensure compliance and drive continuous improvement. The role reports...
- ...Quality Management System for medical devices, guiding NPD teams and coordinating with Product Integrity, Engineering, Regulatory, and Compliance to ensure safe, compliant products from concept to post-market. Ideal candidates have 7-10+ years in quality/QMS for regulated...
$252k - $269k
...Clinical Quality Assurance Senior Leader provides strategic leadership... ...quality programs to ensure compliance across global clinical trials.... ...requires an experienced Clinical QA Senior leader who can build... ...division and touchpoints with GMP. Audit & Inspection Management...Local areaWorldwide- ...coordination, implementation, and maintenance of QA Program. Supervise daily QC Technician... ..., 3rd party and customer audits to ensure compliance to all Federal, State, County, City... ...SQF code and Nasoya Food Standards such as GMP (Good Manufacturing Practice), Pest Control...
$48 - $51 per hour
...Job Description Insight Global is seeking a QA Manager, Finished Goods Commercial for a leading life sciences client. This... ...deviations, and packaging-related investigations while ensuring compliance with GMP standards. The ideal candidate will bring strong experience...- ...Crescent Biopharma in Waltham, MA is seeking a Director/Senior Director, GMP Quality Assurance Operations to provide strategic and hands-on QA leadership for manufacturing activities... ...and process validation, and ensure compliance with Part 11/Annex 11 within a global...
- ...SharkNinja seeks a hands-on leader in product quality to own the 5-star standard from early development through launch readiness. You will embed in NPD programs to ensure safety, certification, consumer validation, and market readiness, guiding cross-functional teams...
- ...Vertex Pharmaceuticals seeks an Associate Director, Analytical Quality Assurance to oversee... ...across Cell & Gene programs. You will drive QA oversight of method validations,... ...audits and CAPA processes to ensure FDA/EMA compliance. The role emphasizes digital quality systems...Contract work
- ...of patient safety, regulatory compliance, and an evolving global supply... ...managing the unique constraints of GMP-compliant, patient-centric... ...), batch yield variability, QA release buffers, and CMO/CDMO... ...and we are one of the world’s leaders in helping drive that change,...Full timeWork experience placementLive inWork at officeLocal area
- ...assisting a Boston-based asset management firm in recruiting a Chief Compliance Officer. The role requires 6+ years of experience in compliance... ...the financial services industry seeking a strategic compliance leader in the Boston area. #J-18808-Ljbffr Masis Professional Group
- ...develop and implement high‑performing EHS programs across multiple facilities. You will guide site management, ensure regulatory compliance, and drive KPI and CPI objectives while handling incident investigations and audits. Based in MA, the role requires 6+ years in EHS...
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