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
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior GMP Compliance Lead - Cell Therapy in Hopkinton, MA vacancy
$199.22k - $284.6k
...patients. We provide transformative therapies in disease areas that include... ...of one or more strategic Cell Therapy assets from clinical proof... ...lifecycle transition. The CMC Lead serves as the single,... ...to relevant governance bodies, senior leaders, and alliance governance...SeniorWork at officeWork from homeWorldwide- ...Description WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and... ...testing for cell therapy products in compliance with all applicable quality systems and... ...considered. · 5+ years of experience in a GMP-regulated Quality Control, laboratory...SuggestedContract workFlexible hoursAfternoon shift
RoslinCT US
Hopkinton, MA10 days ago - ...in Hopkinton, MA is seeking a Sr. Cell Processing Associate to join our cell therapy manufacturing team. You will perform aseptic processing, support GMP operations, and contribute to scalable... ...cleanroom activities, document compliance, and mentor junior staff while...Senior
- ...Job Description WHO WE ARE We at RoslinCT, are a world-leading cell and gene therapy contract development and manufacturing organization creating... .... · Work as part of a team to execute engineering and GMP runs in close collaboration with MST and operations. · Lead...SuggestedContract workFlexible hours
RoslinCT US
Hopkinton, MA14 days ago - ...WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization... .... ACCELERATING YOUR FUTURE The Senior Compliance Specialist is responsible for... ...improvement initiatives in support of GMP cell therapy operations. How You Will...SeniorContract workWork at officeFlexible hours
RoslinCT US
Hopkinton, MA4 days ago - ...is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio through all... ...submission readiness, and guide cross-functional teams to ensure compliance with GMP, FDA and ICH requirements. #J-18808-Ljbffr Anagram...Senior
- RoslinCT is seeking an Associate Director of Manufacturing to lead cell therapy production, ensure cGMP compliance, and build a high-performing team. You will partner with scheduling, quality, and supply chain to optimize production and drive continuous improvement across...
- ...WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing... ...ACCELERATING YOUR FUTURE A Senior Analyst or Compliance Specialist in Quality Control (QC)... ...life science. · 4 to 6+ years of GMP laboratory experience within a...SeniorContract workFlexible hours
RoslinCT US
Hopkinton, MA7 days ago - ...Description WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and... ...clearance and review and approval of GMP documentation including but not limited... ...implementation of QA specific procedures for compliance and identify opportunities for...SeniorFull timeContract workWork at officeFlexible hoursWeekend work
- RoslinCT is seeking a QC Sample Management Lead to oversee in‑process, release, raw material, retain, and stability samples within a cGMP framework. You will coordinate with Manufacturing, QC labs, QA, and external testing partners to ensure timely testing and disposition...
- ...Description WHO WE ARE We are a leading cell therapy contract development and... ...YOUR FUTURE The Senior Process Engineer , as a... ...manufacturing processes, ensuring compliance, and continuously improving... ...Draft and design GMP Batch Records and SOPs to support...SeniorContract workRemote workFlexible hours
RoslinCT US
Hopkinton, MA3 days ago - Replimune, headquartered in Massachusetts, seeks a Quality Assurance professional to support GMP compliance and QA operations. The role interacts with multiple departments to enhance quality processes in a GMP environment and improve readiness for inspections. You will...Senior
- 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- ...being present in the office at least 2 days per week. The Opportunity: join Sun Life's U.S. Compliance team as an expert in Medicaid, Medicare and commercial dental regulations, leading the Regulatory Compliance Management Program for the U.S. Dental Unit. #J-18808-Ljbffr...SeniorWork at office2 days per week
- Replimune seeks a Quality Systems specialist to administer and optimize eQMS platforms, ensuring regulatory compliance and inspection readiness. The role supports governance, workflows, and cross-functional collaboration across sites. The ideal candidate has deep GxP experience...Senior
$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$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- 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...
$105.28k - $150.4k
...provide transformative therapies in disease areas that include... ...impact.Purpose & Scope Senior Process Engineer,... ...responsible for enabling robust GMP execution, technology... ...for human stem-cell-based cell therapy processes... ...or technical reports.Lead or significantly...SeniorWorldwide- ...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...
- 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...
$226.78k - $293.48k
...Join us to do the best work of your career and make a profound social impact as a Senior AI Storage Solutions Lead, Solutions Architecture on our Solutions Architecture Team in Santa Clara, CA ( Field role requires travel). Infrastructure Solutions Group (ISG)...SeniorFull timeDell GmbH
Hopkinton, MA4 days ago- 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
$130k - $155k
...innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to... ...goals.Manage End-to-End Project Delivery: Lead discovery, PoCs, requirements gathering... ...value.Champion Continuous Improvement, Compliance, and Innovation: Drive process optimization...SeniorFull timeRemote workWork from homeFlexible 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
- Sun Life U.S. seeks a senior regulatory compliance professional to lead the U.S. Dental Regulatory Compliance Management Program, guiding risk assessment, control development, and regulatory responses. You will partner with privacy, financial crimes, conduct, and enterprise...Senior
$110k - $140k
...vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able... ...makes everything possible. The Senior Supplier Quality Engineer is... ...supplier audit planning. Lead remediation activities due to... ...regulations (e.g. ISO, CFR, GMP, etc.)Travel, Motor Vehicle...SeniorHourly payFull time- ...Description Job Description WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization... ...requires a solid understanding of technical transfer methodology, GMP and product lifecycle requirements. This is a client facing...Contract workFlexible hours
RoslinCT US
Hopkinton, MA8 days ago - ...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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior GMP Compliance Lead - Cell Therapy. Be the first to apply!
Related searches
- senior living Hopkinton, MA
- senior implementation project manager Hopkinton, MA
- senior level Hopkinton, MA
- senior consulting engineer Hopkinton, MA
- senior human factors engineer Hopkinton, MA
- senior resident engineer Hopkinton, MA
- senior activities Hopkinton, MA
- senior vmware engineer Hopkinton, MA
- senior application security Hopkinton, MA
- senior customer success engineer Hopkinton, MA