Job Title: Quality Control Manager
Summary
This role will oversee the management of quality control activities related to drug product and incoming material, ensuring compliance with internal policies, procedures, and regulatory requirements. The ideal candidate will have a strong background in pharmaceutical quality control, experience with laboratory management, and excellent leadership skills.
Key Responsibilities:
* Manage team and ensure 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.
* Manage performance and provide technical guidance, coaching, and support to team members.
* Assign training requirements and monitor training status of assigned team members.
* Create team plans to ensure resources are properly allocated and utilized effectively.
* Ensure all equipment used for GMP testing is in a qualified state.
* Author, review, and approve complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports.
* Support and sustain Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness.
* Actively participate in inspections by Health Authorities.
* Report metrics to monitor schedule progress and help identify risk areas.
* Support budget definition and adherence to budget target.
* Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in a timely manner.
Additional Responsibilities:
* Oversee QC incoming material, stability, in-process, bulk product testing activities & environmental monitoring testing activities.
* Collaborate cross-functionally and interdepartmentally to define testing priorities, assign work to team members, and monitor progress against schedule.
* Ensure timely completion of stability samples in compliance 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 evaluate any non-compendial supplier test methods against in-house methods and specifications.
* Define incoming testing requirements of Incoming Materials, including specifications.
* Oversee sampling plan and testing regimes for all Incoming Materials.
* Provide oversight of testing contracted to external laboratories.
* Represent QC in cross-functional teams supporting New Product Introductions, Qualification and Risk Assessments.
Safety and Compliance:
* Promote 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.
* Ensure that staff (including short duration and temporary contracts) is properly informed on hazards and trained to act in consequence.
* Promote safe practices and behaviors, assure that EHS requirements are implemented and respected.
* Demonstrate Bristol Myers Squibb values.
* Perform other tasks as assigned.
Qualifications and Experience:
* BS or advanced degree in Microbiology, 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 preferred.
* Exceptional scientific and practical knowledge of analytical techniques (e.g., bio burden, identifications, automatic equipment for testing).
* Exceptional scientific and practical knowledge of environmental monitoring testing.
* 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 (minimum B2 level) of the second language (written and verbal).