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In this role you will share oversight of Quality Control (QC) activities related to Drug Product and Incoming Material to ensure compliance with internal policies, procedures, and regulatory requirements. This position will provide support for design, execution, troubleshooting and monitoring of QC process and testing activities pertaining to raw material (including sampling), stability, in-process, and bulk product. You will be responsible for cGMP compliance of the laboratory area and operations under your responsibility as well as for applying and ensuring staff complies with Environmental Health & Safety applicable procedures. This position reports to the Associate Director Quality Control Drug Product and Incoming Material.

Key Responsibilities

Manage team and ensures cGMP compliance of the laboratory area and operations under responsibility.

• Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met.
• Manages performance and provides technical guidance, coaching and support to team members.
• Assigns training requirements and monitors training status of assigned team members.
• Create team plans to ensure resources are properly allocated and utilized effectively.
• Ensures all equipment used for GMP testing is in a qualified state.
• Authors, reviews, and approves complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports.
• Support and sustains Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness.
• Actively participates in inspections by Health Authorities.
• Report metrics to monitor schedule progress and help identify risk areas.
• Supports budget definition and adherence to budget target.
• Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in timely manner.

Oversee QC incoming material, stability, in-process and bulk product testing activities.

• Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress against schedule.
• Ensure timely completion of stability samples in compliant with company procedures.
• Review and approve documentation as required by laboratory procedures.
• Perform final approval and disposition of QC results.
• Provide technical support to QC team members.
• Ensure compendial compliance of excipients (USP, Ph. Eur., JP and JPE as applicable) and evaluates any non-compendial supplier test methods against in-house methods and specifications.
• Defines incoming testing requirements of Incoming Materials, including specifications.
• Oversee sampling plan and testing regimes for all Incoming Materials.
• Provides oversight of testing contracted to external laboratories.
• Represents QC in cross-functional teams supporting New Product Introductions, Qualification and Risk Assessments.

Support Deviations, Investigations and Change Control Management

• Ensures Deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implement changes in controlled documents.
• Own or lead investigations in collaboration with internal and external functions, as required.
• Approve laboratory investigations, checklists, and deviations as SME/Area Manager.
• Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs).
• Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures.

Promotes safe practices and behaviors.

• Report immediately incidents to Environmental Health and Safety (EHS) department, participate in investigations and identify measures to prevent similar accidents in the future.
• Ensures that staff (including short duration and temporary contracts) is properly informed on hazards and trained to act in consequence.
• Promotes safe practices and behaviors, assure that EHS requirements are implemented and respected.
• Demonstrate Bristol Myers Squibb values.

Performs other tasks as assigned.

Qualifications & Experience

Education and Experience

• BS or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience.
• Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field)
• 1-3 years of Quality Control Laboratory management experience prefer.
• Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques).
• Experience in executing quality control testing of solid oral dosage forms and raw materials.
• Exceptional knowledge of incoming material sampling and inspection.
• Working knowledge of relevant US, EU. and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections.
• Experience with Laboratory Information Management System (LIMS), Learning Management System (LMS) and Enterprise Resource Planning System (ERP).

Required Competencies: Knowledge, Skills, and Abilities

• Subject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and regulations applicable to solid oral dose forms.
• Knowledge of Data Integrity and Good Documentation Practices.
• Ability to accurately understand, follow, interpret, and apply European Pharmacopeia and United States Pharmacopeia requirements and cGMP requirements.
• Exceptional technical writing skills.
• Work to improve efficiencies through process improvements
• Independent, adaptable, and highly motivated.
• Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities.
• Exceptional communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
• Ability to navigate through ambiguity and rapid growth and adapt to change the status quo.
• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
• General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
• Fluent in English or French and professional command of the second language (written and verbal)

Wir setzen uns auf der ganzen Welt leidenschaftlich daf\\xc3\\xbcr ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrit\\xc3\\xa4t bef\\xc3\\xa4higen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das h\\xc3\\xb6chste Potenzial jedes unserer Kollegen hervor.

Bristol Myers Squibb wei\\xc3\\x9f um die Bedeutung von Balance und Flexibilit\\xc3\\xa4t im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.\\n \\n \\n \\n \\n \\n

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