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Director of Microbiology Quality Assurance Leadership
hace 2 meses
Job Summary: We are seeking a highly experienced and skilled Director of Microbiology Quality Assurance to lead our microbiology-related initiatives and ensure compliance with regulatory requirements.
Key Responsibilities:
- Provide leadership and direction for microbiology-related topics in sterile, non-sterile, biologic manufacturing, and/or Microbiology Laboratories.
- Lead the development, deployment, and maintenance of multiple divisional quality guidelines or SOPs to ensure Organon is compliant with cGMPs for these topics.
- In collaboration with stakeholder functions within Organon Manufacturing & Supply (OMS), establish and execute microbiological strategy to support Organon's product portfolio and manufacturing network.
- Establish direct report career development in technical and leadership functions.
- Lead direct reports that identify and translate regulatory requirements and cGMP expectations for Microbiology Laboratory, Sterile and Non-Sterile Operations.
- Maintain the Microbiology quality standards and SOPs in alignment with regulatory requirements and cGMP expectations.
- Ensure consistency in sites meeting the standards for the topic (e.g., providing training, supporting gap assessments, reviewing remediation plans and variances performed by direct reports).
- Tracking metrics for the Organon network sites to meet the microbiological standards.
- Provide support to CMC when inquiries arise from regulators during review of filings.
- Organize and facilitate compliance-related communities of practice related to microbiological topics.
- Representing Organon in external forums, conferences, and working groups such as ISPE, PDA, and similar industry and trade associations.
- 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.
- 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.
- Provides insight and contributes to Quality Management System programs as related to microbiological matters.
- Develops strategic priorities related to microbiological matters.
- Maintains 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.
Requirements:
- Degree required, concentrations in life sciences or related relevant discipline.
- Minimum of 15 years' experience in the FDA and/or EU regulated pharmaceutical environment; preferably with significant work in the area of microbiology.
- In-depth knowledge of end-to-end compendial processes related to microbiology including interactions with global (e.g., USP and EP) and national (e.g., FDA) regulatory agencies.
