10+ years regulated pharmaceutical industry experience
5+ years quality leadership roles
Expert knowledge of 21 cfr parts 210/211/820
This role involves defining and executing the site Quality Strategy aligned with global business objectives and regulatory expectations for BD, a leading global medical technology company
Job Summary
This role involves defining and executing the site Quality Strategy aligned with global business objectives and regulatory expectations for BD, a leading global medical technology company.
The successful candidate will serve as the management representative establishing a Quality Management System ensuring full compliance with Good Manufacturing Practices across manufacturing, laboratory, and distribution functions.
Joining this team offers the opportunity to work alongside inspirational leaders in an inclusive culture that values authentic contributions and continuous learning through BD University.
Matching Summary
This role involves defining and executing the site Quality Strategy aligned with global business objectives and regulatory expectations for BD, a leading global medical technology company.
Skills & Requirements
Must-have
10+ years regulated pharmaceutical industry experience
5+ years Quality leadership roles
Expert knowledge of 21 CFR Parts 210/211/820
EU GMP Annex 1 and ICH Guidelines Q7/Q9/Q10
Experience managing FDA and EMA regulatory inspections
Data integrity principles ALCOA+ implementation
Risk-based decision making and CAPA management
Nice-to-have
Bilingual English/Spanish proficiency preferred
Advanced degree MS MBA or equivalent
Experience with sterile assurance and microbiology
Strong influence skills in matrix organizations
Proven talent development and succession planning
Ability to travel approximately 20% domestically and internationally
Key Requirements
Bachelor's degree in Science or Engineering required
Minimum 10+ years in regulated pharmaceutical industry