Senior Manager Compliance Manufacturing Compliance

1 dag geleden

Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

Transforming Lives through Compliance

Bristol Myers Squibb is a global biopharmaceutical company that is committed to transforming lives through innovative medicines and therapies. We are seeking a highly skilled and experienced Senior Manager Compliance, Manufacturing Compliance to join our team in the Netherlands.

About the Role

The Senior Manager Compliance, Manufacturing Compliance will be responsible for managing the Manufacturing Compliance and Support operations activities, ensuring that our manufacturing processes are compliant with regulatory requirements and industry standards. This role will also be accountable for managing deviations, CAPAs, and quality KPIs, as well as leading a team of specialists to deliver on full C&S scope.

Key Responsibilities

  • Identify, assess, and prioritize potential risks and implement strategies to mitigate their impact, for both compliance and safety.
  • Proactively drive quality record turnaround time (TAT) improvements.
  • Accountable for on-time completion of MFG deviations, CAPAs, and CCs.
  • Represent manufacturing in all applicable cross-functional local and global review boards.
  • Develop, manage, and report on manufacturing compliance KPIs.
  • Coordinate corrective actions with MFG operations and C&S technical training to imbed changes into routing operations training.
  • Responsible for level loading deviations throughout all C&S specialist in collaboration with C&S leadership team.
  • Accountable for manufacturing business continuity planning.
  • Leads and/or represents manufacturing for internal/external inspections.
  • Responsible for driving manufacturing inspection readiness.
  • Accountable for Aseptic Process Simulation life cycle management, execution, and reporting.
  • Accountable for on-time completion of effectiveness verifications of all CAPAs.

Requirements

  • Minimum of 7 years of relevant manufacturing experience.
  • Minimum of 5 years leadership experiences including the management of direct reports required.
  • Minimum of 3 years in a Quality Assurance role managing deviations and CAPA.
  • Extensive knowledge of EOHSS, cGMPs and ATMPs regulations and principles.
  • Demonstrated proficiency in departmental organizational development.
  • Adaptable to a fast-paced, complex, and dynamic business environment.
  • Knowledge of lean manufacturing principles.
  • Excellent communication skills.

What We Offer

Bristol Myers Squibb offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

  • Senior Manager Compliance Manufacturing Compliance

    3 dagen 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 and therapies. We are seeking a highly skilled Senior Manager Compliance, Manufacturing Compliance to join our team in the Netherlands.About the RoleThe Senior Manager Compliance, Manufacturing...

  • Senior Manager Compliance, Manufacturing Compliance

    2 weken geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    About the RoleThe Senior Manager Compliance, Manufacturing Compliance & Support reports to the Associate Director, MFG Compliance & Support. This role is part of the overall manufacturing organization and accountable to manage the Manufacturing Compliance & Support operations activities.Key ResponsibilitiesIdentify, assess, and prioritize potential risks and...

  • IT Quality and Compliance Manager

    2 weken geleden

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

    About the RoleWe are seeking a highly skilled IT Quality and Compliance Manager to join our team at Bristol-Myers Squibb. As a key member of our IT department, you will be responsible for ensuring the quality and compliance of our computer systems and processes.Key ResponsibilitiesComputer System Validation: Develop and implement validation protocols,...

  • Compliance Officer

    4 dagen geleden

    Leiden, Zuid-Holland, Nederland Hoogheemraadschap van Rijnland Voltijd

    Wij zoeken een Compliance OfficerWe zijn op zoek naar een Compliance Officer die zich kan inzetten voor de implementatie van onze compliance- en integriteitsbeleid. Als Compliance Officer ben je verantwoordelijk voor het beoordelen en verbeteren van onze compliance- en integriteitsprocessen.Je taken en verantwoordelijkhedenBeoordelen en verbeteren van onze...

  • Compliance Officer

    1 week geleden

    Leiden, Zuid-Holland, Nederland Hoogheemraadschap van Rijnland Voltijd

    Wij zoeken een Compliance OfficerWe zijn op zoek naar een Compliance Officer die zich kan inzetten voor de implementatie van onze compliance- en integriteitsbeleid. Als Compliance Officer ben je verantwoordelijk voor het beoordelen en verbeteren van onze compliance- en integriteitsprocessen.Je taken en verantwoordelijkhedenBeoordelen en verbeteren van onze...

  • IT Quality and Compliance Specialist

    5 dagen 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 Specialist to join our team in Leiden, Netherlands.Key ResponsibilitiesDevelop and implement Computer System Validation...

  • Senior Manufacturing Associate

    2 weken geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    Job SummaryThe Senior Manufacturing Associate is a key member of the cell therapy team at Bristol Myers Squibb, responsible for leading and driving the execution of manufacturing processes according to established electronic work instructions and production records.Key ResponsibilitiesLead a team of manufacturing associates in the execution of manufacturing...

  • Compliance Officer

    5 dagen geleden

    Leiden, Zuid-Holland, Nederland Swift Voltijd

    About the RoleWe are seeking a highly skilled Compliance Officer to join our team at Swift. As a key member of our Legal & Compliance team, you will play a critical role in ensuring our organization operates in compliance with corporate governance, oversight requirements, and laws and regulations.The ideal candidate will have a deep understanding of...

  • Manufacturing Excellence Leader

    1 week geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Galapagos Cell Therapy Manufacturing OpportunityWe are a dynamic and growing Biotech company with a presence across Europe and the US, headquartered in Mechelen, Belgium. Our mission is to pioneer life-improving medicines and change lives.Role OverviewWe are seeking an Operational Excellence Manager to join our Cell Therapy Manufacturing organization. This...

  • Quality Assurance Manager

    2 weken geleden

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

    Job SummaryBristol-Myers Squibb is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our IT Quality and Compliance department, you will be responsible for ensuring the quality and compliance of our computer systems and processes.Key ResponsibilitiesDevelop and implement quality assurance strategies to ensure compliance...

  • Biotech Process Engineer

    1 week geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Cell & Gene Therapy Process EngineerWe are seeking a highly motivated (Senior) Process Engineer to join our Point-of-Care Manufacturing team in Leiden/NL. As a subject matter expert on the manufacturing process, you will drive operations from site selection through clinical/pivotal/commercial readiness.Your Key Responsibilities:Lead technology transfers and...

  • Regulatory Compliance Consultant

    2 weken geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    About GalapagosWe are a dynamic and growing Biotech company with a strong presence in Europe and the US, headquartered in Mechelen, Belgium.Our MissionWe are committed to changing lives by discovering and developing life-improving medicines. We pioneer for patients, embracing challenges as opportunities for growth and innovation.Our CultureWe value...

  • Kwartiermaker Compliance en Integriteit

    3 dagen geleden

    Leiden, Zuid-Holland, Nederland Hoogheemraadschap van Rijnland Voltijd

    OverzichtWe zoeken een ervaren Kwartiermaker Compliance en Integriteit om ons te helpen bij het borgen van de naleving van wettelijke, regelgevende, ethische en morele normen binnen onze organisatie.VerantwoordelijkhedenDe ins en out van vaak complexe technische wetgeving pragmatisch doorwekken en vertalen in beleid en procedures;De naleving van deze wetten...

  • Process Engineer PoC Operations EU

    1 dag geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    About GalapagosWe are a dynamic and growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium. Our mission is to discover and develop life-improving medicines that change lives.Job SummaryWe are seeking a highly motivated (Senior) Process Engineer to join our Cell & Gene Therapy organization in Leiden/NL. As a...

  • Manufacturing Manager Operational Excellence

    1 dag geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    About GalapagosWe are a dynamic and growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium. Our mission is to discover and develop life-improving medicines that change lives.Job Title: Manufacturing Manager Operational ExcellenceWe are seeking an experienced Manufacturing Manager to join our Cell Therapy...

  • Product Compliance Internship Opportunity

    2 weken geleden

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

    Our OfferWe are offering a unique opportunity to join our team at Leiden Bio Science Park as a Product Compliance Intern.Competitive Compensation: 550 euros per month on a full-time basisCommuting Allowance: Available for eligible candidatesMentoring and Training: A comprehensive program to support your professional developmentInternational Environment: A...

  • Manufacturing Specialist

    4 dagen geleden

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

    Join Our Team as a Manufacturing OperatorWe are seeking a skilled Manufacturing Operator to join our team at Leiden Bio Science Park. As a key member of our production team, you will play a crucial role in ensuring the quality and efficiency of our manufacturing processes.Key Responsibilities:Ensure compliance with cGMP and EHSS regulationsImplement Lean...

  • Quality Assurance Manager

    12 uur 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; we're seeking game-changers who can help us revolutionize the way we approach healthcare.About the RoleWe're seeking a highly skilled Quality Assurance...

  • Senior Manager Capital Projects Lead

    2 weken geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    About the RoleThe Senior Manager Capital Projects will be responsible for leading the site capital project processes, including budget preparation, cost control, and project execution plans. This role will ensure that the approach to project selection through to realization meets with business needs for our new cell therapy facility.Key...

  • Quality Assurance Manager

    1 week 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. As a CSV Engineer within the Leiden IT department, you'll play a critical role in ensuring the quality and compliance of our computer systems.Key Responsibilities:Compliance with local and global SOPs...