Senior Manager, Quality Control Analytical

hace 2 semanas


San Juan, San Juan, Puerto Rico Bristol-Myers Squibb A tiempo completo
Job Title: Senior Manager, Quality Control Analytical

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).
Requirements:
  • 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.
Education and Experience:
  • 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.
Working Conditions:
  • 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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