The Quality Affairs Sr. Director serves as a strategic leader responsible for setting the highest standards of quality across small molecule sterile injectable and large molecule products
Job Summary
The Quality Affairs Sr. Director serves as a strategic leader responsible for setting the highest standards of quality across small molecule sterile injectable and large molecule products.
This role is accountable for establishing rigorous compliance with all regulatory requirements including FDA, EMEA, and Health Canada while managing site-wide cGMP adherence.
The position requires championing strategic quality initiatives and cultivating a culture of quality throughout the organization with strong domestic and international influence.
Matching Summary
The Quality Affairs Sr. Director serves as a strategic leader responsible for setting the highest standards of quality across small molecule sterile injectable and large molecule products.
Skills & Requirements
Must-have
15 years pharmaceutical operations experience
12 years leading quality assurance functions
Expertise in cGMP compliance 21 CFR Parts 210/211
Management of regulatory body inspections FDA EMEA
Oversight of stability chemistry microbiology QC particulate
Nice-to-have
Master's degree in Life Science
Experience with Tech Transfer and new product launches
Statistical methodology application for continuous improvement
International leadership and cross-functional collaboration skills
Key Requirements
Bachelor's degree in Life Science required
Minimum 15 years progressive pharmaceutical operations experience
Minimum 12 years leading functional quality assurance
Thorough understanding of USP requirements and Annex 1