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
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Principal QA - Quality Systems Leader (GMP/CSV) in Hopkinton, MA vacancy
- RoslinCT is seeking a Principal, QA - Validation to provide QA oversight of validation activities across facilities and equipment. The role requires extensive Quality Assurance experience in a GMP environment and hands-on validation knowledge per GAMP. You will collaborate...PrincipalQuality
- ...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
- ...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...PrincipalQualityContract workFlexible hours
- 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
$182.75k - $236.5k
...Job Description Senior Principal Systems Development Engineer Our customers' system requirements are usually highly complex. Bringing... ...We're proud to deliver programs and products to the highest quality standards, on time and within budget. Join us to do the best...PrincipalQualityDell
Hopkinton, MA3 days ago$150k - $205k
...Principal System Engineer Full Spectrum partners with leading companies in MedTech to develop cutting-edge software for medical devices... ...01-5-1. Hardware & Safety: IEC 60601-1, IEC 60601-1-8. Quality & Process: 21 CFR Part 820, IEC 13485, and ISPE GAMP-5. Usability...PrincipalQualityFull Spectrum Software
Westborough, MA20 hours ago- ...leading cell and gene therapy CDMO seeking a Principal, QA - Validation to oversee validation activities for facilities and equipment in a GMP environment. The role involves review and... ...teams to ensure compliance and quality culture. The ideal candidate will have extensive...Quality
- 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
- ...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
$174k - $239.25k
## Principal Software Engineer – Audio Systems & Embedded PlatformsApplylocations: US, MA - Framinghamtime type: Full... ...of robust, portable, and high-quality software solutions.**Key Responsibilities... ...the power of sound. As the world leader in audio experiences, we’re...PrincipalQualityBose Corporation
Framingham, MA20 hours ago$174k - $239.25k
...scaled globally.We are seeking a Principal Software Engineer to lead the... ...role responsible for shaping system-level design and driving... ...of robust, portable, and high-quality software solutions.Key ResponsibilitiesTechnical... ...power of sound. As the world leader in audio experiences, we’re...PrincipalQualityFull time$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$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- ...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
$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 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
$132.4k - $251.6k
...world. This includes phased array radar systems, electronic modules, pedestals, and power... ...Design Department is seeking a Senior Principal Engineer as the GhostEye Program Lead. GhostEye... ..., Integrated Supply Chain, and Quality through hardware development and production...PrincipalQualityTemporary workWork experience placementWork at officeRemote workRelocation packageFlexible 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... ...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
$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$196k - $269.5k
...Development & Agent Ops — Senior Principal Software Engineer Why This... ...Solutions Group is a global leader in Solutions, Storage,... ...energized by solving complex systems challenges, excited to work alongside... ...CI/CD integrations, pipeline quality gates, orchestration...PrincipalQualityDell Technologies
Hopkinton, MA1 day ago$185.2k - $254.65k
...Corporation in Framingham, Massachusetts is seeking an End‑to‑End Systems Lead responsible for the full technical lifecycle of... ...role involves collaboration across various teams to ensure high-quality system delivery and technical accountability. The compensation...Quality- 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
- ...technological orientation in implementing, executing and interpreting quality procedures and test methods. The successful candidate will... ...on complex laboratory equipment including HPLC and GC systems. Investigate and troubleshoot Quality Control methods. Review...PrincipalQuality
- ...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
- ...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
RoslinCT
Hopkinton, MA1 day ago - ...FUTURE The Manager, Quality Assurance Plant Operations... ...responsible for leading QA plant operations and... ...review and approval of GMP documentation including... ...line clearance and quality system review/ approval in the... ...experience as a supervisor/leader or manager. ~ Prior experience...QualityFull timeContract workWork at officeFlexible hoursWeekend work
RoslinCT US
Hopkinton, MA3 days ago
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!
Related searches
- team lead data science Hopkinton, MA
- team leader mental health Hopkinton, MA
- quality control team lead Hopkinton, MA
- merchandise team leader Hopkinton, MA
- quality assurance team leader Hopkinton, MA
- healthcare team leader Hopkinton, MA
- team leader production Hopkinton, MA
- team lead Hopkinton, MA
- compliance team leader Hopkinton, MA
- team supervisor Hopkinton, MA