Director of Microbiology Quality Assurance
hace 1 día
This position can be fully remote. Position Overview:
As a key member of the Organon & Co team, the Director of Microbiology Quality Assurance will provide leadership and direction for microbiology-related topics in sterile, non-sterile, biologic manufacturing, and/or Microbiology Laboratories. The successful candidate will be responsible for developing, deploying, and maintaining multiple divisional quality guidelines or SOPs to ensure Organon is compliant to cGMPs for these topics.
Main Activities:
The Director of Microbiology Quality Assurance will lead direct reports that identify and translate regulatory requirements and cGMP expectations for Microbiology Laboratory, Sterile and Non-Sterile Operations. This includes maintaining the Microbiology quality standards and SOPs in alignment with regulatory requirements and cGMP expectations. The successful candidate will also ensure consistency in sites meeting the standards for the topic, providing training, supporting gap assessments, reviewing remediation plans, and variances performed by direct reports. Additionally, the Director of Microbiology Quality Assurance will track metrics for the Organon network sites to meet the microbiological standards and provide support to CMC when inquiries arise from regulators during review of filings. The successful candidate will also organize and facilitate compliance-related communities of practice related to microbiological topics, represent Organon in external forums, conferences, and working groups, and lead teams to assess impact of proposed and official changes and determine actions needed to maintain compliance and/or prepare correspondence with pharmacopoeia related to microbiology outlining Organon's positions. The Director of Microbiology Quality Assurance will also promote process optimization efforts, application of best practices, and maintenance of tools/programs utilized to facilitate microbiological processes & compliance to evolving regulatory expectations and industry trends. The successful candidate will provide insight and contribute to Quality Management System programs as related to microbiological matters and develop strategic priorities related to microbiological matters. The Director of Microbiology Quality Assurance will maintain a broad-based knowledge of cGMP's, company's Policies, procedures, and guidelines, regulatory requirements, compendial requirements, etc. pertinent to the manufacturing, personal safety, control, testing, and documentation of pharmaceutical products.
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