Associate Director, Quality Assurance

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!
**About this Role**:
Provide compliance leadership and direction to Internal and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances, and finished products.
Support audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are effectively implemented.
- Partner with Internal and CMO management to identify appropriate CAPA to address findings identified during audits and inspections.
Monitor CAPA status and ensure CAPA are implemented in accordance with commitments.
Perform independent verification of CAPA implementation and effectiveness to ensure no recurrence of findings
- Gather regulatory intelligence and partner with Internal and CMO management to prepare sites for audits and inspections.
Assists sites during audits and inspections to ensure successful outcomes
- Monitor and analyze the outcomes of audits and inspections to identify, investigate, and resolve trends.
Report results to Divisional and Regional Quality/Management councils

**Education Minimum Requirements**:

- Education Minimum Requirement: B.S., M.S.
and/or Ph.D. in life sciences, chemistry, engineering or related relevant discipline

**Required Experience and Skills**:

- A minimum of 10 years of quality, operational or technical experience within the pharmaceutical, biopharmaceutical, vaccine, or medical device industry
- Expert knowledge of GMP/GDP requirements for multiple regulatory agencies
- Experience and exposure (not less than 5 years) in managing health authority inspections and communications in a pharmaceutical manufacturing site
- Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and make independent and timely decisions
- Drive Results - set clear performance standards, overcome obstacles; accountable for actions and achieve results
- Make Rapid, Disciplined Decisions - demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions
- Act with Courage and Candor - ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate
- Foster Collaboration - ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment
- Able to travel up to 30% of the time

**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.
**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R512285