Senior Quality Specialist
3 weeks ago
Transforming Patients' Lives through Science
Bristol-Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
We are seeking a highly skilled Senior Quality Specialist - Supplier Oversight to join our team at the Devens Biologics site.
Key Responsibilities:
- Manage the qualification and oversight of GMP/GDP vendors, ensuring compliance with regulatory requirements.
- Perform quality assessments of supplier change notifications and drive actions to completion using change management programs.
- Assist in discrepancy reporting, deviations, and CAPA associated with nonconforming materials or services provided by vendors.
- Establish and execute a process to ensure quality oversight of on-site service vendors.
Requirements:
- Bachelor's degree in science, engineering, biochemistry, or a related discipline.
- Minimum of 4 years of experience in a regulated environment, biopharmaceutical environment, or similar.
- Practical knowledge of US and EU cGMP regulations and guidance, as well as ISO standards.
- Knowledge of electronic systems, including SAP, Veeva, and Syncade.
- Excellent written and oral communication skills.
What We Offer:
- A dynamic and inclusive work environment.
- Opportunities for growth and development.
- A competitive compensation and benefits package.
Equal Employment Opportunity:
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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