Quality Systems Manager — GMP, Veeva & Compliance Leader
Editas Medicine
Editas Medicine in Cambridge, MA is seeking a Manager, Quality Systems to lead health, effectiveness, and compliance across GMP documentation, QMS, and electronic document management. You will oversee vendor qualification, audits, and the electronic systems (Veeva QualityDocs, QMS and ComplianceWire) while driving continuous improvement of quality practices to support early-stage gene therapy programs. #J-18808-Ljbffr Editas Medicine
- ...seeks an Associate Director/Director, GMP QA & Compliance to lead quality operations and oversee global... ...build and develop the GMP QA program, manage DS/DP/IP labeling, coordinate with EU... ...providers to ensure compliant, scalable quality systems for #J-18808-Ljbffr Climb BioSuggested
- Praxis Precision Medicines, Inc. is seeking a Manager, Quality Operations, CMC to lead end-to-end quality for clinical and commercial programs... .... This remote-friendly leadership role requires strong GMP judgment, ownership, and the ability to ensure launch readiness...SuggestedRemote work
$100k - $150k
Team: Quality & Security & ComplianceCity: BostonState: MA Veeva Systems is a mission-driven organization... ...Program Manager role ensures the integrity, compliance, and management of... ...understanding of GxP (GMP, GCP, etc.) regulations... ...group's Senior Leader.Once all interviews...SuggestedWork at officeLocal areaRemote workWork from home3 days per week- Amylyx Pharmaceuticals is seeking an Associate Director, Quality Operations to oversee GMP quality across drug substance, drug product, and finished products in development stages. The role ensures compliance with GMP/GDP standards and supervises activities with contract...SuggestedContract work
- Olema Oncology seeks an Associate Director GMP Quality to oversee GMP activities for clinical and commercial products, focusing on small... ...QC results, COAs, batch disposition, and support supplier compliance. Based in San Francisco or Boston with 10-15% travel, the role...Suggested
- Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including QA review of batch records and supplier compliance. This role partners with CMC, Regulatory and Supply Chain, and will be based in SF...
- 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... ...in the fast-paced pharmaceutical environment. #J-18808-Ljbffr Artech Information System LLC
- ...Pharmaceuticals is seeking an Associate Director, GMP Operational Quality in Boston to oversee team activities... ...knowledge of quality assurance and compliance principles. You will lead a team... ...manufacturing and testing activities, manage quality operations, and provide...
- Monte Rosa Therapeutics seeks a Senior Director/Director Quality GCP to provide strategic oversight of phase-appropriate GCP and GCLP activities, including vendor and investigator site oversight, for active programs. This role requires 75% on-site presence in Boston/Basel...
- .... is seeking an Associate Director, Quality Operations to provide end-to-end quality... ...non-commercial programs, ensuring compliance with GMP/GDP standards. The role involves... ...and reviewing IND CMC submissions, managing quality systems, supporting regulatory inspections,...Remote job
- 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...
$156.6k - $234.8k
...Associate Director, GMP Operational Quality is responsible... ...quality assurance and compliance. The incumbent is... ...facilities. Manages QA On The Floor and... ...Management System representativeParticipates... ...to influence leaders, customers, or... ...QDoccs, Trackwise, Veeva)Education and Experience...Full timeWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week- ...evaluates all candidates in compliance with the Immigration... ...Client Notes: The Veeva BA role requires... ...emphasizes the importance of quality and timely execution... ...reporting, and sample management workflows. Vault... ...requirements into effective system configurations....Permanent employmentLocal areaRemote work
- 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%...
- ...manufacturing, and compliance in a rapidly... ...Life Science Sector Leader is responsible for... ...best practices, and quality benchmarks for life... ...pilot plants, and GMP manufacturing spaces... ..., single-use systems, and digital design... ...trends. Performance Management: Set clear goals,...
$135k - $150k
...Cas9 genome editing systems into a robust pipeline... ...phase-appropriate quality systems and vendor management program. This role is... ...effectiveness, and compliance. Support the management... ...management system (Veeva QualityDocs), the... ...review and approve GMP documentation (SOPs,...Flexible hours$160k - $200k
...experienced Associate Director, GMP Quality Assurance Operations to be a key leader within the Quality... ...ensure phase-appropriate GMP compliance, effective execution of quality systems, and continuous inspection... ..., audits, QTA, issue management and performance monitoringServe...Work at officeRemote work$200k - $260k
...a Director/Senior Director, GMP Quality Assurance Operations. You will... ..., CDMO selection and management, process validation/PPQ, and... ...alignment with Crescent’s Quality System, across a growing portfolio... ...(eQMS, DMS, LMS), ensuring compliance with Part 11 / Annex 11 and...Contract workTemporary workFlexible hours$50k
...leadership and sales to manage the overall... ...SME, with Delivery Leader role, is... ...develop and ensure quality execution of services... ...of automation and compliance solutions across the... ...engineering experience in GMP regulated... ...delivery of facilities, systems and equipment ~...Temporary workFor contractorsWork experience placementWork at officeWeekend work$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... ...experience in GMP Quality Assurance and be proficient in regulatory compliance. The role includes leading quality oversight of clinical...Remote jobContract work$160k - $180k
...the Associate Director, GMP Quality , reporting to the... ...and supporting Supplier compliance. In this role you will... ...Generate metrics for Quality Management Reviews Contribute and... ...effective Quality Systems and performing robust... ...Systems such as Veeva or TrackWise Proficient...Work experience placementWork at officeFlexible hours- ...You are a senior SAP Quality Management leader with deep experience... ...batch traceability, compliance documentation, and regulatory... ...SAP modules and systems including MM, PP, EWM... ...scenarios including GMP and GxP-aligned processes... ...Dot Compliance, ETQ, Veeva Quality, TrackWise,...Full timeWork experience placementLive inWork at officeLocal areaFlexible hours
- ...biotech company, is hiring a Senior Quality Systems Specialist to bolster QA across GMP manufacturing and testing. The... ...You will drive quality processes, manage deviations and CAPAs, oversee... ...to quality metrics and regulatory compliance in a fast-paced environment. #J-...
- Vertex Pharmaceuticals seeks a CMC Quality Compliance Director to lead inspection readiness and compliance for internal and external GMP sites. You will drive governance, risk-based strategies, and a high-quality culture across manufacturing and testing operations in support...
$132k - $198k
...we plan, design, and manage projects that move people... ...is seeking a Tolls Systems & Operations Project Manager... ..., budget and level of quality expected by the client... ...Stantec is a global leader in sustainable... ...AnnuallyPay Transparency: In compliance with pay transparency...Full timeTemporary workPart timeCasual workWork at officeLocal areaRemote workFlexible hours- Lead asset strategy and compliance best practices across products within... ...Product Review/Product Quality Review and trend monitoring.... ...years of experience in people management and project management. Extensive... ...Strategy Development GMP Knowledge Quality Management...
- ...viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn... ...improving patient outcomes. As a trusted leader in breast cancer diagnostics, we invite... ...possible. The Strategic Health Systems Manager, Eastern U.S. is responsible for developing...Full timeContract workWork at officeRemote workWork from homeFlexible hours
$156.6k - $234.8k
...Associate Director (AD) Quality Assurance (QA for QC)... ...quality assurance and compliance. This role is... ...the program life cycle management. Key Duties and Responsibilities... ...of digital quality systems, data management, automation... ..., compliance and GMP regulations.Experience...Full timeContract workSummer workFlexible hours- ...DescriptionGeneral Summary:The CMC Quality Compliance Director is... ...governance across all GMP areas. This position... ...readiness, inspection management, and compliance programs... ...and management system, ensures appropriate escalations... ...; a strategic change leader who delivers results...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week
$250k - $273k
The Senior Director, Quality Compliance is responsible for providing... ...leads key quality systems including supplier... ...global supplier quality management program for CMOs, CROs... ...digital platforms (e.g., Veeva, TrackWise).Establish... ...experience in GMP, GCP, and/or GLP environments...Work at officeRemote work
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