Job Description
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 you will provide end to end product quality oversight for the women health franchise. You will support and drive innovative compliance and manufacturing excellence throughout the commercial life-size of the franchise as part of an integrated supply team. You will partner with the integrated commercial supply team (IDST)/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 organisation, across divisions and on a global basis you will have the decisions 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 impact 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 Stewart and provide support/sponsorship when required for technical initiatives
Support and lead continuous improvement initiatives include value stream mapping, Kaizen events etc
Partner with technical product suit provided list review of the annual product review (AQR)
Provide input and reviews for change controls and support their prioritisation
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 regularity 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; be able to apply sound risk management principles
Excellent project management and organisation skills and strong demonstrated interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of cultures
Demonstrate ability 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 demonstrate community skills by verbally as well as well as writing in English
Welcome to our team:
Our quality organisation ensures every single material that comprise our products are manufactured, processed, tested, packaged, stored and distributed aligned with our high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, we create an interdependent global manufacturing network dedicated to deliver a compliant, and reliable supply to customers and patients on time, every time, across the globe.
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
25%
Flexible Work Arrangements:
Remote Work
Shift:
Valid Driving License:
Yes
Hazardous Material(s):
Number of Openings:
1
