External Quality Assurance, Specialist

**Job Description**:
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it

**Primary Activities**
- Reports to the Associate Director of External Partners, for direction and instruction concerning Quality Operations. Executes daily activities in area of responsibility and delivers improvements.
- Acts as the company Quality point of contact for the external partner and as a liaison for contact and communications between the partner and internal company personnel.
- Assures the development and maintenance of a Quality Agreement with the external partners. These activities cover all aspects of External Partner operations related to the quality of products including technology and method transfers, supplier qualifications, equipment, processes and method validation, Quality Agreement, artwork, routine QA and QC activities including change control/requests, batch records review and deviations investigation, periodic product review, quality complaints, product release.
- Works with the External Partner to ensure that effective and robust Quality Systems and Quality management are in place to comply with required regulations, policies and guidelines. Provides on-site guidance in the preparation of metrics, procedures and guidelines where warranted.
- Provides proactive support in training and coaching to initiate quality improvements within Operations and Quality; reviews Annual Stability and Product reviews.
- Ensures all activities are completed according to established procedures, Quality Agreements (with Partner Sites), and all associated documentation are completed to a high standard of accuracy.
- Ensures that all investigations at External Partners related to company Products are fully investigated with any assigned actions effectively implemented within the agreed time frame.
- Ensures all due diligence and audit observations at External Partners related to company Products are fully investigated with proposed actions effectively implemented within the agreed time frame.
- Ensures that SOPs are prepared and maintained in compliance with regulatory standards, company requirements and required frequency.
- Closely collaborates with appropriate business and operations areas, both internal and external, to achieve company objectives.
- Provides technical expertise to External Partner with regards to company's requirements.
- Manages compliance issue promptly and perform risk assessment on critical issue to prevent stock out situation in the market.
- Participates in incident investigations and audits as required and ensures required actions implemented.
- Ensures both operational knowledge and technical skills are maintained and compliant against individual training requirements.

**S**kills required**:

- Degree in pharmacy.
- Prefer 3 to 5 years manufacturing/technical/quality experience in pharmaceutical manufacturing industry.
- Meticulous, Self-motivated, Able to work under pressure.
- Good time management skills, Team player, High integrity.
- Strong interpersonal, relationship building and leadership skills.
- Advanced in English, both spoken and written.
- Knowledge of applicable GMP regulatory requirements.
- Applies sound scientific principles, theories, concepts, techniques and skills.
- Effective communication skills, ability to work effectively on cross-functional teams.
- Demonstrated organizational skills, proactive and self-motivated with ability to multi-task.

**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.**

At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and wil