Senior Manager Compliance, Manufacturing Compliance

3 weken 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 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 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. 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

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

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