Product Quality Assurance Director

4 days ago


Cramlington, Northumberland, United Kingdom Organon Full time

Organon, a leading pharmaceutical company, is seeking a highly experienced Director of Product Quality Assurance to join its team. This is a remote opportunity with a preference for candidates located in Europe.

About the Role

The successful candidate will report to the Associate Vice President (AVP) of Internal Manufacturing Quality and provide end-to-end product quality oversight for the women's health franchise. Key responsibilities include driving innovative compliance and manufacturing excellence throughout the commercial life cycle of the franchise as part of an integrated supply team.

This role requires strong collaboration with the integrated commercial supply team (IDST) and global value chain management team (VCMT) to drive continuous improvement activities and holistic risk management specific to the franchise/products. The ideal candidate will also represent the AVP Internal Manufactured Quality on key improvement initiatives within Internal Manufacturing and across the company.

Responsibilities
  • Ensure continuous compliant supply across nodes and resolve testing and release issues.
  • Support and direct Significant Investigations (SI) and understand franchise/product risks and impacts due to significant investigations.
  • Contribute to fact-finding meetings and partner with the technical product suite to provide a list review of the annual product review (AQR).
  • Partner with Technical Product Steward to provide a holistic review of complaints.
Requirements

The successful candidate must have a Bachelor's or Master's degree in chemistry, pharmacy, biology, microbiology, or chemical engineering (or equivalent). A minimum of 10 years of experience in the Pharmaceutical industry, with solid knowledge of global GMPs and global regulatory requirements, is essential.

Expertise and broad experience in Quality and Manufacturing, including product development and registration, are required. Solid knowledge of global GMP and regulatory requirements; experience in Women's Health franchise preferred. Excellent problem-solving skills based on science, facts, data, and understanding of regulatory requirements in complex and evolving environments are necessary.

Strong communication skills both verbally and in writing in English are required. Our quality organization ensures every single material that comprises our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our high standards of quality and meets all regulatory requirements.



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