Product Leader Women's Health Director
3 weeks ago
At Organon, we are seeking a Director Quality Assurance, Product Leader Women's Health to drive innovation and excellence in our women's health franchise. As a key member of our team, you will be responsible for providing end-to-end product quality oversight, ensuring continuous compliance and manufacturing excellence throughout the commercial lifecycle of our franchise.
Key Responsibilities- Report to the Associate Vice President (AVP) Internal Manufacturing Quality and partner with the Integrated Commercial Supply Team (IDST)/Global Value Chain Management Team (VCMT) to drive continuous improvement activities and holistic risk management.
- Represent the AVP Internal Manufactured Quality on key improvement initiatives within Internal Manufacturing and across the company, as appropriate.
- Provide support and direction to ensure continuous compliant supply across nodes and resolve testing and release issues.
- Support and direct Significant Investigations (SI) and understand franchise/product risks and impact due to significant investigations, and contribute to fact-finding meetings.
- Partner with Technical Product Steward to provide a holistic review of the annual product review (AQR) and complaints.
Requirements include a Bachelor's or Master's degree in chemistry, pharmacy, biology, microbiology, chemical engineering, or equivalent, and at least 10 years of experience in the Pharmaceutical industry with solid knowledge of global GMPS and global regulatory requirements.
As a Product Leader, you will bring expertise in Quality and Manufacturing, product development, and registration, including solid knowledge of global GMP and regulatory requirements. You will also possess excellent problem-solving skills based on science, facts, data, and understanding of regulatory requirements in complex and evolving environments.
We are committed to ensuring that every single material that comprises our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our high standards of quality and meet all regulatory requirements. Our quality organization creates an interdependent global manufacturing network dedicated to delivering a compliant and reliable supply to customers and patients on time, every time, across the globe.
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