Senior Manager, Quality Control Analytical
hace 2 semanas
Bristol Myers Squibb is seeking a highly skilled Senior Manager, Quality Control Analytical to join our team. As a key member of our Quality Control department, you will be responsible for ensuring the highest quality standards in our analytical testing processes.
Key Responsibilities:- Lead and manage a team of quality control analysts to ensure effective, timely, and efficient operations and compliance with cGMP requirements.
- Develop and report key performance indicators (KPIs) for QC lab operations performance.
- Maintain high team performance and drive continuous improvement initiatives using operational excellence tools.
- Hire, mentor, and develop team members to support business operations.
- Provide developmental feedback, coaching, and create a collaborative environment to enhance team performance and integration across site departments.
- Approve investigations and creation of meaningful CAPA for improved lab performance.
- Collaborate with managers across the QC network to harmonize best practices.
- Represent department in regulatory inspections (internal and external audits).
- Extensive experience with flow cytometry and cell imaging, including flow-related technologies related to analysis.
- Extensive experience with various molecular biology analytical techniques, including but not limited to ELISA, qPCR, and scientific knowledge in the characterization and transfer of pharmaceutical products.
- Knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
- Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.
- Ability to collaborate cross-functionally to drive operational and quality excellence.
- Advanced organizational and time management skills.
- Demonstrated critical reasoning, problem-solving, troubleshooting, investigation, and decision-making skills with only general guidance.
- Advanced teamwork and facilitation skills.
- Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
- Requires strategic thinking and ability to work independently.
- Advanced knowledge of Quality Systems, including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.
- Ability to interpret and author general, technical, and complex business documents.
- Advanced knowledge and implementation of data integrity principles.
- Ability to represent the department in regulatory inspections.
- Bachelor's degree required, preferably in Biology or related science. Advanced degree preferred.
- Minimum of 5 years of combined work experience in QC analytical testing within a manufacturing GMP facility.
- Proficiency in flow cytometry, ELISA, PCR, and cell handling/cell culture.
- Strong ability to speak to and explain all the above techniques.
- People leadership: A minimum of 2 years' experience.
- The incumbent will be required to work in office and laboratory environments.
- The incumbent may be required to gown for entry into the Aseptic Core and other supporting areas on an as-needed basis.
- The incumbent (or designee) will be expected to be on call to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.
- Occasional travel may be required.
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