Senior Quality Systems Lead - GMP & Compliance
Socket
Editas Medicine is seeking a Senior Specialist, Quality Systems Management in Cambridge, MA to lead and optimize quality systems, ensure regulatory alignment, and support supplier audits. You will collaborate across functions to strengthen compliance, manage electronic documents, and drive process improvements. The role requires a 5–8 year track record in Quality Systems within biopharma, experience with cGMP, and hands-on work with Veeva Quality apps and compliance tooling. #J-18808-Ljbffr Socket
- Editas Medicine is seeking a Senior Specialist, Quality Systems Management, to advance our lead in vivo program and strengthen QA processes. You will support electronic document management, QMS, and training systems, while coordinating supplier qualification and audit...QualitySenior
$151.2k - $226.8k
...document control, training, and quality records support consistent compliance across functions and... ...across GxP domains (GMP/GLP/GCP) and alignment with... ...items, training compliance)Lead QMS simplification/... ...ISO Lead Auditor, Quality Systems)Training in electronic QMS...Quality- ...GMP Operational Quality Senior Manager The GMP Operational Quality Senior Manager... ...of quality assurance and compliance. This role coordinates or... ...cross-functional quality systems Conducts GMP document review... ...Experience successfully leading event investigations, Root...QualitySeniorContract workShift work
$228k - $342k
...DescriptionSenior Director, Quality Data, Digital Systems & ComplianceGxP Data... ...position summary:The Senior Director, Quality Data, Digital Systems & Compliance, serves as a pivotal... ...position promotes leading practices, supports... ...Quality experience (e.g., GMP, GCP, IT). Experience...QualitySeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week- Scorpion Therapeutics Associate Director, GMP Quality will lead QA activities for GMP release of Clinical Trial Materials and Commercial batches... ...QP for product release while driving continuous improvement of Quality Systems and SOPs. #J-18808-Ljbffr Scorpion TherapeuticsQualitySenior
- 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 LLCQualitySenior
- 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...QualitySeniorContract work
- ...months is to advance our lead in vivo development... ...supporting phase-appropriate quality systems and vendor management... ...Your Impact: As the Senior Specialist, Quality... ...their effectiveness, compliance, and continuous improvement... ..., review, and manage GMP documentation,...QualitySeniorFlexible hours
$102.3k - $138.3k
Join Rapid7 as a Senior Business Systems Analyst - Finance & Accounting, where you will partner with... ...financial controls, SOX compliance, auditability, and data security requirements... ...operational usabilityThe skills and qualities you'll bring includeDemonstrated experience...QualitySeniorFull timeWork experience placementLocal area- Alnylam is seeking a Senior Manager, Medical Writing to collaborate with project teams on clinical document development in compliance with GCP and SOPs. The role oversees contract writers... ...clinical program and ensures timely, high-quality deliverables. The candidate will plan...QualitySeniorContract work
$212k - $333.19k
...lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA)For the project...QualitySeniorMinimum wageTemporary workLocal areaRemote workWorldwide$127k - $172k
...Possible”, we are leading the charge toward a... ...disease.DescriptionThe Senior IT Business Analyst... ...Practice) and GMP (Good Manufacturing Practice) Systems Manager is responsible... ...partnership to Quality Assurance (QA) and... ...systems validation and compliance support of laboratory...QualitySeniorTemporary workSummer workWork at officeLocal area- ...Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs,... ..., and oversee responses to RFIs with minimal supervision, driving high-quality submissions and robust compliance. #J-18808-Ljbffr Relay TherapeuticsQualitySenior
$200k - $260k
...vision is to build a world leading oncology company bringing... ...We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You... ...alignment with Crescent’s Quality System, across a growing... ...eQMS, DMS, LMS), ensuring compliance with Part 11 / Annex 11 and...QualitySeniorContract workTemporary workFlexible hours$119.3k - $178.9k
...resolution, world-class regulatory compliance and advisory services, and... ...peers.Goodwin is seeking a Senior Business Systems Analyst / Product Owner to... ...a Big Four firm or another leading management or technology... ...adoption, user experience, quality, efficiency, and business...QualitySeniorFull time- Integer Holdings is seeking a Quality Inspector to lead inspections from raw material intake through final assembly, ensuring GMP-compliant quality and documentation. You will identify non-conforming materials and support NCR processes while maintaining Calibrations and...QualitySenior
$210k - $290k
The Role: The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight... ...and its external partners. Lead Generate’s CMC Quality... ...integrity, computerized systems compliance, and alignment with global...QualitySeniorContract workFor contractorsShift work- Integer Holdings Corporation seeks a Quality Inspector to support inspection and testing... ...from input to final assembly, ensuring GMP and QMS compliance. This role requires minimal supervision... ...in the absence of a manager or team lead. Responsibilities include visual, dimensional...QualitySenior
$107.1k - $138.6k
...Senior Quality Systems Specialist eGenesis is a clinical-stage biotechnology... ...porcine kidney, is the Company's lead program and is currently... ...Quality Systems supporting GMP Manufacturing and Testing across... ...improvements to enhance compliance and improve method and product...QualitySenior- ...partnerships, CADM provides high-quality and efficient services to... ...Research Administration and Compliance Systems team to deliver software... ...their research projects. The Senior Business Analyst supports the... ...project team including technical lead, developers, and QA team...QualitySeniorWork at officeShift work
- ...YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is... ...areas. Operates in compliance with regulations, company policies... ...regulatory product strategy and the Quality Dossier Program (QDP). Significant...QualitySeniorLocal area
$93.6k - $154.5k
...regulated environments where validated systems, reliable data, and regulatory compliance are critical to business... ...supporting validation activities across quality, laboratory, manufacturing, and... ...life sciences domain, including: Lead computer systems validation activities...QualitySeniorFull timeWork experience placementSummer holidayFlexible hours- Werfen seeks a Senior Engineering Group Lead to own design controls and product reliability for Class II... ...output. This hands-on leader will set system integration strategies, develop plans... ...Mechanical, Electrical, Software, Quality, Regulatory, and PM teams while mentoring...QualitySenior
$130.8k - $209.4k
...and processes align with Quality Assurance (QA) guidance and compliance requirements.This role is... ...that supports operating system deployments, in-place upgrades... ...in regulated (GxP, GMP, or validated) environments... ...have aspired to build the leading mRNA technology platform,...QualitySeniorPermanent employmentFull timeWork at officeWork from home$130k - $170k
...bodies and daily lives.WHOOP is hiring a Senior Lead, DTC Commercial Planning & Strategy to... ...Analytics to build out the commercial operating system of the DTC business (planning,... ...assisted work aligns with the same high-quality standards as personal contributions.This...QualitySeniorFull timeWork at officeRelocation$159.8k - $239.8k
...DescriptionThe Associate Director of GMP Operational Quality Assurance is an advanced... ...of quality and regulatory compliance. The individual adapts to... ...Quality Escalation Lead (QEL), Escalation Action Committee... ...-for FG Quality Management System of Global Commercial...QualityFull timeContract workWork experience placementSummer work- ...tolerability, durability and quality of life. Are you ready... ...innovation? As the Senior Global Medical Affairs... ...investment decisions, lead pre-launch scientific efforts... ...and transforms health systems, leverages digital and... ....Regulatory Insight & Compliance: The Senior GMAL...QualitySeniorFull timeWorldwideRelocation package
- ...Description Job Description Manufacturing & Quality Systems Gap Assessment Consultant Location:... ...controls, as well as regulatory and GMP requirements associated with hormone... ...and identify gaps affecting regulatory compliance. Assess regulatory expectations...Quality
- Philips is seeking a Supplier Quality Engineering Leader for Ultrasound to define and execute the supplier quality... ...strategy across the business. You will ensure regulatory compliance, drive supplier performance, and lead cross-functional collaboration with engineering and...QualitySenior
$140k - $185k
...establishing the leading, fully integrated... ...highly motivated Senior IT Business Analyst... ...to join our IT Lab Systems team. This role is... ...partner closely with Quality Control, Quality... ...supporting Beam's GMP and non-GMP operations... ...integrity and compliance with applicable regulatory...QualitySeniorFull time
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Quality Systems Lead - GMP & Compliance. Be the first to apply!
- senior operations technician Cambridge, MA
- senior cloud service delivery manager Cambridge, MA
- senior it service manager Cambridge, MA
- senior chief engineer Cambridge, MA
- sr operations manager Cambridge, MA
- senior account director Cambridge, MA
- senior director clinical development Cambridge, MA
- sr accountant Cambridge, MA
- senior financial analyst remote Cambridge, MA
- senior manager accounts payable Cambridge, MA


