Senior Manager, MSAT Investigations, Leiden
Senior Manager, MSAT Investigations, Leiden
-
2300 Leiden, Nederland
-
Geplaatst op: minder dan een week geleden
-
Onthouden
Advertentietekst
Position Summary
The Senior Manager, Investigations will start as an individual contributor and will become a people leader to lead a team that provides investigations support to the Leiden Cell Therapy Manufacturing Facility when the workload increases. The Senior Manager will build a team and establish processes for investigations, corrective and preventative actions, audit readiness, APQR, and product complaints.Responsibilities
Provide direct supervision of a team of lead investigators. In partnership with Quality Assurance, establish, maintain, and execute investigations, CAPA, and product complaints programs. Perform root cause analysis investigations for complex deviations and trend deviations. Establish and report metrics for compliance activities (investigations, CAPAs, training, commitments, etc.).Provide oversight of investigations/CAPA management to ensure timely and compliant closure. Represent the Site MS&T Investigations team in cross‑functional forums. Perform review and approval of site and department SOPs. Ensure safe and compliant cGMP operations and maintain permanent inspection readiness; actively support regulatory inspections. Interact with other teams including Process Engineering, Manufacturing Operations, QualityAssurance, Supply Chain Operations, Site Engineering, and Quality Control.Stay current with industry trends and BMS standards and participate in best practice forums consistent with function responsibilities. Knowledge, Skills, and Abilities
Proficient in cGMPs and multi‑national biopharmaceutical/cell therapy regulations. Excellent verbal and written communication skills with ability to influence at all levels. Ability to think strategically and translate strategy into actions. Ability to prioritize and provide clear direction to team members in a highly dynamic environment.Leadership: hire, integrate, and develop high‑quality talent; enforce performance measures and provide developmental feedback and coaching; create an environment of teamwork, open communication, and a sense of urgency; support organizational strategic goals linked to the company strategy; champion continuous improvement, problem solving, andincident prevention initiatives; drive strong collaboration within the Leiden Cell Therapy Manufacturing Facility and across the network; deliver 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. Minimum of 10 years’ experience in biopharmaceutical operations with 4+ years of prior management experience. Experience leading investigations, performing root cause analysis, and identifying correctiveand preventative actions.Experience in cell therapy, biologics, or vaccine manufacturing/support. Experience in building and growing an organization into a high‑performing team. Experience with Operational Excellence and Lean Manufacturing (plus). Experience in product complaints and APQRs (plus). Working Conditions
Position may require working in a cleanroom manufacturing environment approximately 15% of the time; remainder of work is performed in an office environment. Benefits
Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs to support employees in their personal and professional goals. Flexibility and balance are emphasized. Equal Employment Opportunity
Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
#J-18808-Ljbffr
The Senior Manager, Investigations will start as an individual contributor and will become a people leader to lead a team that provides investigations support to the Leiden Cell Therapy Manufacturing Facility when the workload increases. The Senior Manager will build a team and establish processes for investigations, corrective and preventative actions, audit readiness, APQR, and product complaints.Responsibilities
Provide direct supervision of a team of lead investigators. In partnership with Quality Assurance, establish, maintain, and execute investigations, CAPA, and product complaints programs. Perform root cause analysis investigations for complex deviations and trend deviations. Establish and report metrics for compliance activities (investigations, CAPAs, training, commitments, etc.).Provide oversight of investigations/CAPA management to ensure timely and compliant closure. Represent the Site MS&T Investigations team in cross‑functional forums. Perform review and approval of site and department SOPs. Ensure safe and compliant cGMP operations and maintain permanent inspection readiness; actively support regulatory inspections. Interact with other teams including Process Engineering, Manufacturing Operations, QualityAssurance, Supply Chain Operations, Site Engineering, and Quality Control.Stay current with industry trends and BMS standards and participate in best practice forums consistent with function responsibilities. Knowledge, Skills, and Abilities
Proficient in cGMPs and multi‑national biopharmaceutical/cell therapy regulations. Excellent verbal and written communication skills with ability to influence at all levels. Ability to think strategically and translate strategy into actions. Ability to prioritize and provide clear direction to team members in a highly dynamic environment.Leadership: hire, integrate, and develop high‑quality talent; enforce performance measures and provide developmental feedback and coaching; create an environment of teamwork, open communication, and a sense of urgency; support organizational strategic goals linked to the company strategy; champion continuous improvement, problem solving, andincident prevention initiatives; drive strong collaboration within the Leiden Cell Therapy Manufacturing Facility and across the network; deliver 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. Minimum of 10 years’ experience in biopharmaceutical operations with 4+ years of prior management experience. Experience leading investigations, performing root cause analysis, and identifying correctiveand preventative actions.Experience in cell therapy, biologics, or vaccine manufacturing/support. Experience in building and growing an organization into a high‑performing team. Experience with Operational Excellence and Lean Manufacturing (plus). Experience in product complaints and APQRs (plus). Working Conditions
Position may require working in a cleanroom manufacturing environment approximately 15% of the time; remainder of work is performed in an office environment. Benefits
Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs to support employees in their personal and professional goals. Flexibility and balance are emphasized. Equal Employment Opportunity
Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
#J-18808-Ljbffr
Belangrijke informatie
-
BedrijfsnaamBristol-Myers Squibb
-
PositieSenior Manager, MSAT Investigations
Veiligheidstips
Betaal een potentiele werkgever niets om een baan te krijgen.
Meer informatie over deze advertentie
Senior Manager, MSAT Investigations is geplaatst in de Leiden overige banen rubriek op Locanto.
Op dit moment is dit de enige advertentie in deze rubriek onder Leiden.
Geïnteresseerd in meer? Verbreed je zoekopdracht om advertenties in nabijgelegen gebieden van Leiden. te bekijken. Dit omvat overige banen in Oegstgeest, Alphen aan den Rijn en Noordwijk. In totaal zijn er 7 advertenties binnen een straal van 15 km voor deze rubriek. Als je deze advertenties wilt bekijken, klikt u hier.