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    Senior Manager Compliance, Manufacturing Compliance - Leiden, Nederland - Bristol Myers Squibb

    Bristol Myers Squibb
    Bristol Myers Squibb Leiden, Nederland

    1 week geleden

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    Beschrijving
    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 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.

    Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .

    Bristol Myers Squibb Netherlands

    Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands.

    The Netherlands is also home to our first European Cell Therapy facility , located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it

    The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team.

    Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer

    For more information about Bristol Myers Squibb Netherlands, visit us at or

    Position Summary

    The Senior Manager Compliance, MFG 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. The Senior Manager Compliance is accountable for the contributions that directly support Manufacturing quality compliance, review board representation, and manufacturing inspection readiness. This role is responsible, in collaboration with Manufacturing management, to manage Manufacturing deviations, CAPAs, CCs, quality KPI adherence, inspection readiness, MFG business continuity, and Aseptic Process Simulation program. The Senior Manager Compliance leads a team of specialists that will work in a matrix organization to deliver on full C&S scope. The Senior Manager Compliance is expected to collaborate with other C&S managers to organize and allocate the specialists to meet business demands.

    Key Responsibilities
    • Identifying, assessing, and prioritizing potential risks and implementing strategies to mitigate their impact, for both compliance and safety.
    • Proactively drives quality record turnaround time (TAT) improvements.
    • Accountable for on-time completion of MFG deviations, CAPAs, and CCs.
    • POC and representative for manufacturing in all applicable cross-functional local and global review boards.
    • Develop, manage, and report on manufacturing compliance KPIs.
    • Coordinates 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.
    Technical Training
    • Coordinates required trainings for specialists to be qualified for quality record authoring and ownership. Front Line Support.
    • Accountable for receiving and processing all escalations and deviations generated from FLS.
    • Develops, manages, and reports on KPIs related to MFG operational execution throughout the MFG organization.
    Qualifications & Experience
    • 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
    #BMSCART

    #LI-Hybrid

    Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.

    Why You Should Apply

    If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

    Uniquely Interesting Work, Life-changing Careers
    With a single vision as inspiring as Transforming patients' lives through scienceTM , 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.

    On-site Protocol

    BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

    Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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