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Quality Assurance Manager

vor 2 Monaten


Boudry District, Schweiz Bristol Myers Squibb Vollzeit

Job Summary

This role is responsible for ensuring the quality of Bristol Myers Squibb's products manufactured by external contractors. The Quality Assurance Specialist will oversee the review of commercial bulk and finished drug products, deviation, complaint, and change control record management, and provide accurate interpretation of quality and cGMP compliance requirements.

Key Responsibilities

  • Support the Quality Operations Manager in the Contract Manufacturing Management team to ensure compliance with regulatory and corporate requirements.
  • Review batch records, master production/packaging records, and executed batch records to ensure compliance with GMP and registration requirements.
  • Manage change control requests and process product complaints.
  • Support the review of Annual Product Quality Review reports.
  • Participate in self-inspections and external audits of contractor manufacturers and distributors.
  • Ensure quality metrics are up-to-date, consistent, and accessible to the Virtual Plant Team.
  • Perform trend reviews and compile metrics.

Required Competencies

  • Deep knowledge of cGMP/GDP regulations pertinent to the USA, EU, and other international markets.
  • Ability to balance business targets with scientific and quality decisions.
  • Strong analytical and problem-solving skills.
  • Ability to build relationships, partnerships, and influence quality decisions at external/internal sites.
  • Good communication and organizational skills.
  • Project management skills.

Required Qualifications and Experience

  • MSc or equivalent in Bio-Science-Pharmaceutical disciplines.
  • At least 5 years of experience in a pharmaceutical company (MS&T and Quality preferred).
  • Experience in chemical, biological, and/or pharmaceutical operations, enabling firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences, and interface with research & development.
  • Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA, EMA, and/or Swissmedic.
  • Experience interacting with external manufacturers and supporting quality at external manufacturing sites.
  • Business Fluent in English; French and German good proficiency is an asset.