Organon is looking for a Director Quality Assurance, Product Leader Women's Health to join our team. This is a remote opportunity with a preference for candidates to be located in Europe.
Purpose of the Role:
As the Director of Quality Product Leader Women's Health, you will report to the Associate Vice President (AVP) Internal Manufacturing Quality and provide end-to-end product quality oversight for the women's health franchise. You will support and drive innovative compliance and manufacturing excellence throughout the commercial life cycle of the franchise as part of an integrated supply team. You will partner 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.
You will also represent the AVP Internal Manufactured Quality on key improvement initiatives within Internal Manufacturing and across the company, as appropriate.
In this individual contributor position, you will work independently with all levels of the organization, across divisions and on a global basis. You will have the decision-making authority on product quality and franchise quality. The amount of travel in this role will be around 10 to 20% of the time.
Role Responsibilities:
* Provide support and direction to ensure continuous compliant supply across nodes and to resolve testing and release issues.
* Support and direct Significant Investigations (SI) and understand franchise/product risks and impacts due to significant investigations, and contribute to fact-finding meetings.
* Partner with the Analytical Product Steward and provide support/sponsorship when required for analytical initiatives like method and compendial updates.
* Partner with the Technical Product Steward and provide support/sponsorship when required for technical initiatives.
* Support and lead continuous improvement initiatives including value stream mapping, Kaizen events, etc.
* Partner with the technical product suite to provide a list review of the annual product review (AQR).
* Provide input and reviews for change controls and support their prioritization.
* Complaints partner with Technical Product Steward to provide holistic review.
Your Profile:
* Bachelor's or Master's degree in chemistry, pharmacy, biology, microbiology, chemical engineering (or equivalent).
* At least 10 years of experience in the Pharmaceutical industry, with solid knowledge of global GMPs and global regulatory requirements.
* Expertise and broad experience in Quality and Manufacturing and in product development and registration including 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; able to apply sound risk management principles.
* Excellent project management and organization skills and strong demonstrated interpersonal, communication, collaborative, and leadership skills in dealing with a broad variety of cultures.
* Demonstrated ability to manage across a broad framework of initiatives and influence employees across all levels and all functions, and ability to create simplicity out of complex environments.
* Strong communication skills both verbally and in writing in English.
Welcome to our team:
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. Partnering across our internal manufacturing facilities, we create 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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