Bristol Myers Squibb is seeking a Senior Manager of API Quality Operations to oversee quality and compliance management for contract manufacturing organizations. The candidate will be responsible for managing relationships with contract manufacturers, ensuring adherence to quality standards, and providing expertise in regulatory matters
Job Summary
This role provides quality operations and compliance oversight for Active Pharmaceutical Ingredient and intermediate contract manufacturing organizations.
The position involves managing vendor relationships, overseeing deviation systems, and supporting pre-approval inspections for third-party suppliers.
Bristol Myers Squibb offers competitive benefits including an annual bonus, pension contribution, family health insurance, and 27 days of annual leave.
Matching Summary
Match Score: 85
Bristol Myers Squibb is seeking a Senior Manager of API Quality Operations to oversee quality and compliance management for contract manufacturing organizations. The candidate will be responsible for managing relationships with contract manufacturers, ensuring adherence to quality standards, and providing expertise in regulatory matters.
Salary
Competitive salary; Annual bonus included; Pension contribution, family health insurance, 27 days annual leave, gym access, life assurance
Skills & Requirements
Must-have
GMP manufacturing environment experience
API manufacture quality expertise
Contract manufacturer relationship management
Deviation and change control management
Process validation protocol review
Quality agreement negotiation
Technical transfer project leadership
Nice-to-have
Operational Excellence (OpEx) experience
Strong analytical and problem solving skills
Experience with Health Authority Agency
Cross-functional team collaboration
Proactive direct report development
Key Requirements
Minimum BSc degree preferably with postgraduate qualification
Minimum 5 years experience in GMP manufacturing environment
Five years pharmaceutical industry experience specifically in API manufacture
In-depth knowledge of cGMP regulations USA EU and international markets
Travel required on a routine basis approximately 25%