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Head of Microbiology Quality Assurance
hace 3 meses
Job Overview
**This role is available for remote work**
Position Summary:
- Accountable for steering and guiding microbiology-related initiatives in sterile and non-sterile manufacturing environments, as well as within Microbiology Laboratories.
- Directs the formulation, implementation, and upkeep of various divisional quality protocols or Standard Operating Procedures (SOPs) to ensure compliance with current Good Manufacturing Practices (cGMPs).
- Collaborates with various stakeholder functions within Organon Manufacturing & Supply (OMS) to devise and execute a microbiological strategy that aligns with Organon's product offerings and manufacturing framework.
- Facilitates career advancement for direct reports in both technical and leadership capacities.
Key Responsibilities:
- Supervises direct reports in identifying and interpreting regulatory requirements and cGMP standards for Microbiology Laboratories, as well as Sterile and Non-Sterile Operations.
- Upholds microbiology quality benchmarks and SOPs in accordance with regulatory standards and cGMP expectations.
- Ensures uniformity across sites in meeting established standards (e.g., through training, supporting gap analyses, reviewing remediation strategies, and variances executed by direct reports).
- Monitors metrics across the Organon network to ensure adherence to microbiological standards.
- Provides assistance to CMC during regulatory inquiries related to filings.
- Organizes and leads compliance-focused communities of practice pertaining to microbiological subjects.
- Acts as a representative for Organon in external discussions, conferences, and working groups such as ISPE, PDA, and other relevant industry associations.
- Guides teams in evaluating the implications of proposed and official changes, determining necessary actions to maintain compliance, and preparing correspondence with pharmacopoeia regarding microbiology.
- Encourages process improvement initiatives, the application of best practices, and the maintenance of tools/programs that facilitate microbiological processes and compliance with evolving regulatory standards and industry trends.
- Contributes insights and supports Quality Management System programs related to microbiological issues.
- Establishes strategic priorities concerning microbiological matters.
- Maintains comprehensive knowledge of cGMPs, company policies, procedures, guidelines, regulatory requirements, and compendial standards relevant to the manufacturing, safety, control, testing, and documentation of pharmaceutical products.
Qualifications:
- Required degree in life sciences or a related field, with a minimum of 15 years of experience in the FDA and/or EU regulated pharmaceutical sector, particularly in microbiology.
- Extensive understanding of end-to-end compendial processes, including interactions with global (e.g., USP and EP) and national (e.g., IP, ChP, JP, etc.) pharmacopeias.
- Proficient in microbiological analytical techniques utilized in commercial testing of excipients, drug substances, and drug products, ideally across various product modalities (e.g., biologics and pharmaceuticals).
- Expertise in EMEA, MHRA, and FDA regulations.
- Advanced knowledge of Sterile Processing, Microbiology Laboratory & Testing, and microbiology topics for nonsterile or bioburden-reduced products.
- Extensive experience in regulatory inspections and responses.
- Strong ability to listen to diverse perspectives and develop solutions while advocating for a position.
- Demonstrated capability in strategy and organizational development, project management, and establishing meaningful metrics.
- Proficient in leading teams and managing multiple projects/tasks with competing priorities.
- Excellent collaborative and communication skills.
About Organon:
Organon is dedicated to delivering innovative health solutions that empower individuals to lead their best lives. As a $6.5 billion global healthcare organization, we focus on making a significant impact on women's health, expanding access to leading biosimilars, and enhancing lives through a diverse and trusted portfolio of health solutions. Our vision is straightforward: to ensure a better and healthier everyday life for every woman.
Equal Opportunity Employment:
Organon is committed to embracing diversity in all its forms and ensuring equal opportunity in employment terms and conditions for all employees and job applicants, irrespective of race, color, religion, sex, sexual orientation, age, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
