Jobid=620132966617980106 (0.0997)
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. 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, Investigations, starts as an individual contributor and will become a people leader to leads a team that provides investigations support to the Leiden Cell Therapy Manufacturing Facility when the workload is increasing. The Senior Manager will build a team and establish processes for investigations, corrective and preventative actions, audit readiness, APQR, and product complaints.
Duties/Responsibilities:
Providing direct supervision of a team of lead investigators
In partnership with Quality Assurance, establishing, maintaining, and executing the investigations, CAPA, and product complaints programs
Performing Root Cause Analysis Investigations for complex deviations and trend deviations.
Establishing and reporting metrics for compliance activities (investigations, CAPAs, training, commitments, etc.)
In collaboration with Quality Assurance, providing oversight of Investigations/CAPA management to ensure timely and compliant closure
Representing the Site MS&T Investigations team in cross-functional forums
Performing review and approval of site and department SOPs
Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections
Interacting with other teams including Process Engineering, Manufacturing Operations, Quality Assurance, Supply Chain Operations, Site Engineering, and Quality Control
Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities.
Knowledge, Skills, and Abilities
Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
Excellent verbal/written communication skills and ability to influence at all levels
Ability to think strategically and to translate strategy into actions
Ability to prioritize and provide clear direction to team members in a highly dynamic environment
Leadership:
Hires, integrates, and develops high quality talent, capable of delivering against the site & department goals and objectives
Defines and enforces performance measures; provides developmental feedback and coaching
Creates an environment of teamwork, open communication, and a sense of urgency which enhances unit performance and integration across site departments
Supports organizational strategic goals and objectives that are linked to the overall company strategy
Champions continuous improvement, problem solving, and incident prevention initiatives
Drives strong collaboration within the Leiden Cell Therapy Manufacturing Facility and across the network
Delivers business results through timely and quality decision making and advice
EDUCATION AND EXPERIENCE
Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline, or its equivalent is required
A minimum of 10 years’ experience in biopharmaceutical operations with 4+ years of prior management experience required
Experience leading investigations, performing root cause analysis, and identifying corrective and preventative actions required
Experience in cell therapy, biologics, or vaccine manufacturing/support required
Experience in building and growing an organization into a high performing team
Experience with Operational Excellence and Lean Manufacturing is a plus
Experience in product complaints and APQRs is a plus
WORKING CONDITIONS: Position may require working in cleanroom manufacturing environment approximately 15% of the time. Remainder of work is performed in an office environment.
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.
Lees hier meer
Deel deze vacature:
