This Quality Director is responsible for leading and managing all Quality related programs and activities to support manufacturing operations
Job Summary
This Quality Director is responsible for leading and managing all Quality related programs and activities to support manufacturing operations.
The initial 5 years of this role will predominantly focus on leading/directing all Quality aspects in completing the conceptual design, basis of design, detailed design, construction, commissioning/qualification, process validation, and regulatory submission/approval for this new U.S.-based Biotherapeutic manufacturing facility.
Johnson & Johnson is an Equal Opportunity Employer and is committed to providing an inclusive work environment where each person is considered as an individual.
Matching Summary
This Quality Director is responsible for leading and managing all Quality related programs and activities to support manufacturing operations.
Skills & Requirements
Must-have
Quality Control testing
Quality Assurance review
Compliance activities
Product Release activities
GMP regulations
regulatory inspections
Nice-to-have
fostering a quality culture
mentoring and coaching staff
driving change
ethical decision-making
innovative and tenacious
Key Requirements
Bachelor's degree in science, Pharmaceutical Engineering, Engineering, Pharmacy, Biochemistry, Microbiology, Biology, Chemistry or Molecular Biology
10-15 years' experience in a significant leadership position within the biological and/or pharmaceutical industry
5 years' experience in a Quality leadership role
Experience & Interaction with FDA/EMEA regulatory requirements