Huidige banen gerelateerd aan Manager IT Quality and Compliance - Leiden - Bristol-Myers Squibb

  • IT Quality and Compliance Manager

    1 maand geleden

    Leiden, Zuid-Holland, Nederland Bristol-Myers Squibb Voltijd

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a company that is pushing the boundaries of what is possible in the field of biotechnology. We are seeking a highly skilled and experienced IT Quality and Compliance Manager to join our team.Key ResponsibilitiesDevelop and implement Computer System Validation Protocols, including Validation...

  • Manager IT Quality and Compliance

    3 maanden geleden

    Leiden, Nederland Bristol-Myers Squibb Voltijd

    Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients,...

  • Quality Assurance Manager

    1 maand geleden

    Leiden, Zuid-Holland, Nederland Bristol-Myers Squibb Voltijd

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a company that pushes the boundaries of what's possible in the field of biotechnology. We're not just looking for talented individuals to join our team; we're seeking passionate professionals who share our vision of transforming patients' lives through science.About the RoleWe're seeking a...

  • Senior Manager Compliance, Manufacturing Compliance

    6 maanden geleden

    Leiden, Nederland Bristol Myers Squibb Voltijd

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • IT Operations and Compliance Specialist

    3 weken geleden

    Leiden, Zuid-Holland, Nederland ProQR Therapeutics Voltijd

    Job Title: IT Operations and Compliance SpecialistCompany: Pro QR TherapeuticsLocation: Leiden, NLJob Type: Full-timeAbout Us: Pro QR Therapeutics is a biotechnology company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, USA. We are focused on the development of life-changing RNA therapies to meet the unmet need of...

  • Senior Manager Compliance Manufacturing Compliance

    3 weken geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    Transforming Lives Through ComplianceBristol Myers Squibb is a leader in the pharmaceutical industry, and we're looking for a Senior Manager Compliance Manufacturing Compliance to join our team. As a key member of our manufacturing organization, you will be responsible for managing compliance and quality assurance operations, ensuring that our products meet...

  • Senior Manager Compliance Manufacturing Compliance

    3 weken geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    Transforming Lives through ComplianceBristol Myers Squibb is a global biopharmaceutical company that is committed to transforming lives through innovative medicines. As a Senior Manager Compliance Manufacturing Compliance, you will play a critical role in ensuring that our manufacturing operations meet the highest standards of quality and compliance.Key...

  • Quality Assurance Manager

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Leiden Bio Science Park Voltijd

    Join Our TeamWe are seeking a highly motivated and experienced Quality Assurance Manager to join our dynamic team at Leiden Bio Science Park.About the RoleAs a Quality Assurance Manager, you will be responsible for ensuring the quality and integrity of our products throughout the entire product pipeline, from development to commercial production.Key...

  • Senior Manager Compliance Manufacturing Compliance

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    Transforming Lives through ComplianceBristol Myers Squibb is a leader in the pharmaceutical industry, and we're looking for a Senior Manager Compliance, Manufacturing Compliance to join our team. In this role, you'll be responsible for managing the Manufacturing Compliance and Support operations, ensuring that our manufacturing processes meet the highest...

  • Senior Manager Compliance Manufacturing Compliance

    1 maand geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    Transforming Lives through ComplianceBristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. We are seeking a highly skilled Senior Manager Compliance, Manufacturing Compliance & Support to join our team in the Netherlands.About the...

  • Quality Assurance Manager

    1 maand geleden

    Leiden, Zuid-Holland, Nederland WilsonHCG EMEA Ltd. Voltijd

    About the RoleWe are seeking a highly skilled and experienced Quality Assurance Manager to join our team at WilsonHCG EMEA Ltd. As a key member of our organization, you will be responsible for leading and executing audit and validation programs for our Information Systems.Key Responsibilities:Manage, coordinate, plan, and administrate the TDQA program to...

  • Senior Manager Compliance Manufacturing

    2 weken geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    Transforming Lives through ComplianceBristol Myers Squibb is a leader in the pharmaceutical industry, and we're seeking a Senior Manager Compliance Manufacturing to join our team. In this role, you'll be responsible for managing Manufacturing Compliance & Support operations activities, ensuring quality compliance, and representing the company in review...

  • Quality Assurance Manager

    4 weken geleden

    Leiden, Zuid-Holland, Nederland WilsonHCG EMEA Ltd. Voltijd

    About AstellasAstellas is a progressive health partner that delivers value and outcomes where needed. We pursue innovative science, focusing on areas of greatest potential, and develop solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.We work directly with...

  • IT Operations and Compliance Specialist

    2 dagen geleden

    Leiden, Zuid-Holland, Nederland ProQR Therapeutics Voltijd

    Company OverviewProQR Therapeutics is a biotechnology company listed on NASDAQ with offices in the Netherlands and Massachusetts, USA. The company focuses on developing life-changing RNA therapies to meet the unmet needs of individuals and families with common and rare diseases.A team of over 150 enthusiastic professionals from diverse backgrounds and...

  • Quality Assurance Manager, Technology and Data

    2 weken geleden

    Leiden, Zuid-Holland, Nederland WilsonHCG EMEA Ltd. Voltijd

    Job Opportunity:Astellas is a progressive health partner, delivering value and outcomes where needed.We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.We work...

  • Compliance and Manufacturing Leadership Role

    5 dagen geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    Company Overview:Bristol Myers Squibb is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.About the Role:We are seeking a highly skilled Senior Manager Compliance, Manufacturing Compliance & Support to join our team in the Netherlands. This...

  • Quality Assurance Manager

    2 weken geleden

    Leiden, Zuid-Holland, Nederland Leiden Bio Science Park Voltijd

    Join Our Team as a Quality Assurance ManagerWhat We OfferWe strive to create a dynamic environment that fosters growth and self-improvement for our team members.Our company culture is built around transparency, open communication, and a commitment to patient care.As a Quality Assurance Manager, you will be part of our team at our headquarters in Leiden,...

  • Senior Manager Compliance, Manufacturing Compliance

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Leiden Bio Science Park Voltijd

    Job Title: Senior Manager Compliance, Manufacturing ComplianceBMS is seeking a Senior Manager Compliance, Manufacturing Compliance & Support to join our team at Leiden Bio Science Park.Key Responsibilities:Develop and implement compliance strategies for manufacturing operationsCollaborate with cross-functional teams to ensure compliance with regulatory...

  • Compliance Coordinator and Paralegal

    6 maanden geleden

    Leiden, Nederland Pharming Group Voltijd

    **About Pharming** Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including...

  • Quality Systems Specialist

    10 uur geleden

    Leiden, Zuid-Holland, Nederland Pharming Group Voltijd

    Transforming the lives of patients with rare, debilitating, and life-threatening diseases requires a strong foundation in quality systems. As a Quality Systems Specialist at Pharming Group N.V., you will be instrumental in ensuring compliance with current EU and USA GMP legislation for computerized systems.The role involves evaluating, analyzing, and...

Manager IT Quality and Compliance

3 maanden geleden

Leiden, Nederland Bristol-Myers Squibb Voltijd
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Position Summary
  • Draft and review of Computer System Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, protocols.
  • Develops complete understanding of BMS policies and procedures related to all aspects of computer system validation.
  • Liaises with cross-functional SMEs in developing and promulgating the computer system validation methodology for the Cell Therapy function.
  • Participates actively with other groups to analyze and address process deficiencies. Work collaboratively with peers within various departments and Quality groups.
  • Provides validation subject matter expertise (SME) in the Digital Plant environment and contributes to multi-function teams, advises personnel on validation matters, and defends their work before regulatory agencies and auditors.
  • Provides CSV expertise and guidance related to management, peers, and lower-level professionals.
Key Responsibilities
  • CSV Engineer within Leiden IT department.
  • Responsible for compliance with local and global SOPs during qualification.
  • Compliance with Project Change Management Procedure and PCM drafting, review and approval.
  • Audit and Operational readiness for site.
  • Change Management during qualification and sustaining.
  • Other duties as assigned by Associate Director of IT Quality and Compliance.

Qualifications & Experience
  • Bachelors in Engineering, IT, Science field or equivalent
  • Minimum 10+ year's relevant industry experience. Prior Cell Therapy experience is highly valued but not required.
  • Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
  • Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation and Historians.
  • Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
  • Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 and good documentation practices.
  • Demonstrated success working in a high-performing, business results-driven environment.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients' lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.