Senior GMP Compliance Lead - Cell Therapy
RoslinCT US
RoslinCT US in Hopkinton, MA seeks a Senior Compliance Specialist to lead investigations, deviations, CAPAs, change controls, and continuous improvement within GMP cell therapy operations. You will partner with Manufacturing, Quality Assurance, Validation, MS&T, and Supply Chain to ensure timely, compliant investigations and audit readiness; guide risk-based problem solving and KPI establishment. Join a culture of integrity and scientific excellence. #J-18808-Ljbffr RoslinCT US
- RoslinCT is a world-leading cell and gene therapy CDMO seeking a Principal, QA - Validation to oversee validation... ...for facilities and equipment in a GMP environment. The role involves review... ...cross-functional teams to ensure compliance and quality culture. The ideal...Senior
- ...WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing... ...ACCELERATING YOUR FUTURE The Senior Compliance Specialist is responsible for ensuring... ...improvement initiatives in support of GMP cell therapy operations. How You...SeniorContract workWork at officeFlexible hours
- Replimune Group, Inc. in Framingham, MA seeks a Principal Associate I/II, Quality Assurance to support GMP compliance and product disposition for BDS, DP, and FDP across internal and external facilities. You will collaborate with QA, QC, Regulatory, and Clinical teams,...Senior
$119k - $170k
...patients. We provide transformative therapies in disease areas that include... ...tangible impact.Purpose & Scope Lead and manage drug product readiness activities for cell therapy programs through the... ...and pharmaceutical sciences, and GMP manufacturing principles. Experience...SeniorWorldwide$210k - $250k
...innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to... ...System, which makes everything possible.The Senior Director, Strategy leader, is responsible... ...in Marlborough, MA. .What you will do:Lead the end‑to‑end strategic planning process...SeniorFull time$145.46k - $207.8k
...science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology... ....Purpose & Scope In this role as an Integrative Science Lead within Cell and Gene Therapy Research, you will serve as a central liaison...Worldwide- ...WHO WE ARE We at RoslinCT are a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies... ...experience · 7+ years working in Biopharma industry in a GMP environment, technology transfer experience preferred ·...SeniorFull timeContract workFlexible hours
$135k - $145k
...vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able... ...everything possible.The Senior Manager, Digital Content Strategy... ...brand consistency and compliance with legal and regulatory standards... ...drive traffic, and support lead generation.Collaborate with...SeniorFull time- Intelas is seeking a skilled Biomedical Equipment Technician lead in Framingham, MA to mentor and train junior technicians and drive maintenance of complex clinical equipment. You will ensure compliance with ISO 13485/QMP policies, implement KPI improvements, and manage...Senior
- RoslinCT is seeking a Cell Processing Associate to support manufacturing processes for cell therapies in a cGMP environment. You will assist with aseptic sampling, operation of incubators, and use of single-use systems to facilitate cell targeting, expansion, and harvesting...
- ...The role focuses on review/approval of CSV deliverables, governing procedures, and training content for computerized systems within a GMP environment. The ideal candidate has extensive QA experience in pharma/biotech, with 3+ years in Software Validation QA and a strong...
- ...equipment. The role requires extensive Quality Assurance experience in a GMP environment and hands-on validation knowledge per GAMP. You will collaborate cross-functionally to ensure compliance with cGMP and 21 CFR Part 11, mentor colleagues, and support Health Authority...
$135k - $160k
...developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to continuously... ...System which makes everything possible.The Senior Leader, Project Management will be responsible for leading enterprise projects within Cytiva’s...SeniorFull timeNight shift- Sanofi in Framingham, MA is seeking a Head of Quality Compliance to oversee GMP activities and compliance programs across site operations including... ...Biologics, Biosurgery, and Northborough. The role leads a team to ensure readiness for inspections and drives continuous...
- Replimune is seeking a Senior Associate, Plant Quality Assurance to provide day‑to‑day quality oversight for drug substance, drug product... ...collaborates with Manufacturing and Quality Control to ensure compliance, review batch records, and maintain a quality‑driven culture....Senior
- WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization... ...Quality Systems experience in a GMP environment and experience in... ...Support the evaluation of systems for compliance with 21 CFR Part 11 and Annex 11. Optimize...Contract workFlexible hours
- WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization... ...Quality Assurance experience in a GMP environment and experience in... ...Support the evaluation of systems for compliance with 21 CFR Part 11 and Annex 11. Support...Contract workFlexible hours
- Boston Scientific is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for product development, sustaining... ...will partner with cross-functional teams to ensure regulatory compliance across the product lifecycle and help advance innovative technologies...Senior
- CRISPR Therapeutics, Inc. in Framingham, MA, is seeking a Senior GXP Facilities Specialist to lead day-to-day utilities, maintenance and project... ...and capex initiatives, ensuring safety and regulatory compliance. The role requires strong leadership, collaboration with...Senior
- ...Therapeutics is a leading biopharmaceutical... ...first CRISPR-based therapy, approved for eligible... ...with sickle cell disease and transfusion... ...SummaryThe Senior Specialist, Site Supply... ...systems, and compliance. ResponsibilitiesEstablish... ...knowledge of GMP operations. Demonstrates...SeniorFull timeWork at office
$94.57k - $135.1k
...for patients. We provide transformative therapies in disease areas that include oncology,... ...ongoing data integrity and 21 CFR Part 11 compliance across manufacturing and laboratory... ...computerized systems.Strong knowledge of GMP, 21 CFR Part 11, and data integrity principles...SeniorWorldwide- Jobtailor in Marlborough, MA seeks a senior accounting leader to manage the close, financial statements, and regulatory reporting in a banking/financial services environment. You will own controls, audit readiness, and cross-functional collaboration with senior management...Senior
$105k - $125k
...vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able... ...everything possible.The Senior Product Engineer is responsible... ...process changes to ensure compliance, mitigate risk and maintain... ...techniques and Lean tools.Leading cross functional teams through...SeniorFull timeLocal areaNight shift- ...Lead Quality Assurance EngineerAre you ready to accelerate your... ..., new medicines, and cell and gene therapies.At Cytiva you will be able to... ...SystemLead or support quality and compliance projects as requested, and... ...relevant industry experience (e.g. GMP medical device,...Senior3 days per week
- ...practical, proactive employment solutions across global functions. You will advise senior HR and executives on complex employment matters, manage disputes, and monitor evolving compliance requirements while partnering with international teams. We seek a JD with 8+ years...Senior
- ...decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused... ..., the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent... ...and maintenance competence on GMP utilities and equipment.*...SeniorImmediate start
- Rodenhiser Home Services Inc. seeks a Senior Designer in Holliston, MA to lead architectural projects from concept through construction. This role requires... ...manage multiple projects, conduct site visits, ensure compliance with codes, and mentor junior staff, contributing to...Senior
- Boston Scientific seeks a Principal Clinical Quality Assurance Specialist to lead QA activities within assigned business areas, ensuring compliance with GCP, ISO standards and Boston Scientific policies. You will conduct internal and external audits, support CAPA and inspection...Senior
$152k - $197k
...cancer treatment with therapies designed to... ...description: The Senior Validation... ...required for cGMP compliance. ~ Own and... ...training is kept in GMP compliant state.... ...maximize immunogenic cell death and the induction... ...modalities, leading to the versatility...SeniorFor contractorsLocal areaFlexible hours$145.46k - $207.8k
...for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology... ...role requiring the scientist to lead from the bench, while mentoring/managing... ...molecules, biologics, gene therapies, cell therapies, or RNA-based therapeutics.Strong...Contract workWorldwide
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