Principal QA - Quality Systems Leader (GMP/CSV)
RoslinCT US
RoslinCT US in Hopkinton, MA, seeks a Principal, QA - Quality Systems to provide QA oversight of Quality Systems and Computer System Validation. 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 background in 21 CFR Part 11/Annex 11. #J-18808-Ljbffr RoslinCT US
- ...patients. ACCELERATING YOUR FUTURE The Principal, QA - Quality Systems is responsible for providing QA... ...extensive Quality Systems experience in a GMP environment and experience in Computer... ...CAPAs as necessary (as is pertains to CSV, Data Integrity, Quality Management Systems...PrincipalQualityContract workFlexible hours
- ...in Wellesley, MA, seeks an Associate Director/Director, GMP QA & Compliance to lead quality operations and oversee global clinical supply through regulatory... ...Regulatory Affairs, and external providers to ensure compliant, scalable quality systems for #J-18808-Ljbffr Climb BioQuality
- Replimune is seeking a Director of Quality Systems in Framingham, MA to lead the development and implementation of quality systems ensuring... ...the organization. The ideal candidate will have 10+ years in QA/QS within the pharmaceutical industry, experience with electronic...Quality
- RoslinCT US is seeking an on-site QA Training Specialist to support the training program within the Quality Management System. You will help implement and maintain the Learning Management... ...functional teams to ensure compliance with GMP and QMS standards. Ideal candidates have 3-...QualityWork at office
- ...experience every day.As a Principal Clinical Quality Assurance Specialist,... ...audits of clinical systems, investigative sites,... ...improvement of Clinical QA processes, audit... ...Manufacturing Practice (GMP) and Good Documentation... ...global medical technology leader for more than 45 years...PrincipalQualityHourly payLocal areaRelocationShift work3 days per week
$150k - $205k
...devices. With projects focused on embedded systems, mobile apps, robotics, engineers at... ...professional growth opportunities. Principal System Engineer: At Full Spectrum... ...Safety: IEC 60601-1, IEC 60601-1-8. Quality & Process: 21 CFR Part 820, IEC 13485,...PrincipalQuality$157.25k - $203.5k
...Principal Systems Development Engineer Help architect and deliver Dell's L11 rack-scale AI solutions: fully integrated racks that bring... ...subsystems into complete rack-level systems that meet performance, quality, and manufacturability requirements. Ensure the...PrincipalQuality- Sigma Systems, Inc. is seeking a remote Sr. Manager, GMP Quality for a 6-month contract. You will act as QA representative on cross-functional project teams, coordinating with Quality, Production, CMC, and contract manufacturing organizations to ensure compliant release...QualityRemote jobContract work
- Sanofi in Framingham, MA is seeking a Head of Quality Compliance to oversee GMP activities and compliance programs across site operations including... ...improvement while maintaining a robust quality management system. The candidate will oversee relationships with regulators...Quality
- ...cross-functional support of GxP activities as they relate to Quality Systems. This position leads the administration, optimization, and continuous... ...MasterControl preferred. Experience supporting commercial GMP manufacturing operations preferred. Experience leading cross-...PrincipalQualityLocal areaFlexible hours
$176k - $242k
....If you're energized by solving complex systems challenges, excited to work alongside AI... ...ll find your place here.Hardware Senior Principal Engineer - System IntegrationJoin us as... ...hardware products that meet performance, quality, cost, and schedule objectivesDesirable...PrincipalQuality- ...gene therapy contract development and manufacturing organization. The QA Training Specialist role supports maintenance and ongoing management of the Training Program within the Quality Management System, on-site in Hopkinton, MA. You will implement and maintain the...QualityContract work
- ...cGMP framework. You will coordinate with Manufacturing, QC labs, QA, and external testing partners to ensure timely testing and... ...in QC sample handling, inventory management, and documentation, with a focus on traceability and quality systems. #J-18808-Ljbffr RoslinCTQuality
$106.8k
...digital solutions across Global Quality Assurance (QA) and Regulatory Affairs (RA)... ...oversee global AI software system implementations spanning... ...computer system validation (CSV) principles. Requisition ID... ...a global medical technology leader for more than 45 years, we advance...QualityHourly payWork at officeRelocationRelocation packageShift work3 days per week$120k - $155k
...future. Summary of job description: The Principal Associate I/II, Plant Quality Assurance (PQA) reports to the... ...responsibilities: Serve as the second shift QA lead working alongside manufacturing... ...improvement of the Quality System. Other duties, as assigned. Preferred...PrincipalQualityLocal areaFlexible hoursShift workAfternoon shift- ...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...Quality
$158k - $200k
Associate Director/Director, GMP QA & Compliance About Climb: Climb... ...membranous nephropathy, systemic lupus erythematosus, and immune... ...Associate Director/Director, GMP Quality and Compliance. Reporting to... ..., commercial launch. As a leader within the Quality organization...QualityContract workTemporary workWork at officeLocal area$134k - $173.5k
...future. Summary of job description: The Principal Associate I/II, Quality Assurance reports to the Director,... ...responsible for proactively support GMP compliance focusing on Quality processes... ...Replimune GMP compliance and Quality systems: change control, deviation, and...PrincipalQualityContract workLocal areaFlexible hours- Replimune is seeking a Quality Systems SME to lead GxP-compliant electronic quality platforms at our Framingham site. You will administer Veeva Quality and MasterControl, drive QA document control, and support inspections across global regulatory requirements. This role...Quality
- 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...Quality
$102k
Overview The Principal FP&A Analyst - Finance Systems & Process Optimization will be a key member of the ASD... ...streamline workflows, enhance data quality, and enable a more efficient and insight... ...AutomationPartner with FP&A leaders to redesign planning processes for...PrincipalQualityLocal area- Replimune Group, Inc. in Massachusetts is seeking a Quality Assurance professional to support GMP compliance, batch release, and QA operations across departments. You will partner with Regulatory, Clinical, and Manufacturing to ensure readiness for inspections, maintain...Quality
- Replimune in Framingham, MA, seeks a Principal Associate I/II, Plant Quality Assurance for a second-shift role providing real-time quality oversight across... .... The ideal candidate has 5-7+ years in pharma QA/manufacturing, with strong communication and documentation...PrincipalQualityAfternoon shift
- 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... ...and external facilities. You will collaborate with QA, QC, Regulatory, and Clinical teams, manage batch release...Quality
$110k - $160k
Senior Manager, Quality Systems (Global Process Owner) Reporting to the head of Global Quality Systems... ...process. Serve as the approver on CSV validation documents ensuring Part 11 compliance. Engage with Site Quality leaders, Operations, R&D, IT, Legal, and other stakeholders...QualityTemporary workWork experience placementWork at officeLocal areaWork from homeFlexible hours- Dell Technologies is seeking an Electrical Systems Senior Principal Engineer to drive advanced hardware development across analogue and digital domains. You will work on enterprise-grade products, collaborating across firmware, mechanical, power and thermal engineering...Principal
- The End-to-End Systems Lead at Bose Corporation owns the full technical lifecycle of experiences and platforms, from concept to delivery, ensuring quality, performance, and scalability. You will coordinate across product management, research, design, software, and test...Quality
$107.5k - $204.5k
...more secure world. Join us and help shape the future of aerospace and defense.We have an immediate need for an onsite Principal Software Systems Quality Engineer (Compliance) to support Land & Air Defense Systems (LADS) in Marlborough, MA. LADS programs include Global...PrincipalQualityTemporary workWork experience placementWork at officeLocal areaImmediate startRemote workRelocationMonday to FridayFlexible hours- ...patients. ACCELERATING YOUR FUTURE The QA Training Specialist is a position responsible... ...of the Training Program within the Quality Management System. How You Will Make an Impact Support... ...and periodic refresher training such as GMP training, eQMS workflows training, and...QualityContract workWork at officeFlexible hours
- ...whatever your ambitions. About this role:The Principal Design Quality Assurance Engineer is a seasoned... ...Life Cycle Management, and Quality Systems initiatives related to design and development... ...world. As a global medical technology leader for more than 45 years, we advance...PrincipalQualityHourly payImmediate startRelocation packageShift work3 days per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Principal QA - Quality Systems Leader (GMP/CSV). Be the first to apply!
- compliance team leader Hopkinton, MA
- team lead data science Hopkinton, MA
- team supervisor Hopkinton, MA
- team leader mental health Hopkinton, MA
- quality control team lead Hopkinton, MA
- leader Hopkinton, MA
- team leader production Hopkinton, MA
- quality assurance team leader Hopkinton, MA
- team leader Hopkinton, MA
- merchandise team leader Hopkinton, MA


