Global API Quality Operations Director
vor 2 Wochen
Bristol-Myers Squibb is a pioneering healthcare company dedicated to transforming patients' lives through groundbreaking science. We're seeking an exceptional Associate Director, Quality Operations Global API to lead our quality and compliance oversight management of third-party manufacturers engaged by External Manufacturing within a cross-functional team.
About the Role:
We are looking for a highly experienced professional with seven to ten years' experience in the API pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency. The ideal candidate will possess extensive knowledge of cGMP regulations pertinent to the USA, EU, and other international markets, as well as direct experience interacting with Health Authorities and managing Health Authority inspections.
Responsibilities:
- Lead the quality and compliance oversight management of third-party manufacturers engaged by External Manufacturing within a cross-functional team.
- Ensure that the Quality resources working on priority Virtual Plant Teams (VPTs), or multiple VPTs, are appropriate, effective, and coordinated.
- For specified products, lead a team to support the release activities in accordance with the conditions of our manufacturing authorization and provide strategic oversight on the API release process.
- Proactively manage contract manufacturer relationships from a quality and compliance perspective.
What You'll Bring:
- A strong analytical and problem-solving skillset, enabling you to assess the right balance between business targets and scientific and quality decisions.
- Excellent negotiation, communication, and presentation skills across all levels, both internal and external to BMS.
Benefits and Opportunities:
- Competitive salary: $140,000 - $170,000 per year.
- Comprehensive benefits package, including medical, dental, and vision insurance.
- 401(k) plan with company match.
- Paid time off and holidays.
- Opportunities for professional growth and development.
Join Our Team:
Bristol-Myers Squibb is committed to creating an inclusive work environment where diverse perspectives and ideas thrive. We encourage talented professionals like you to apply for this exciting opportunity to transform patients' lives through science.
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