Drive the implementation and operational readiness of Quality functions at new Biopharma manufacturing facilities across the EU, US, Canada, and other global locations.
Lead cross-functional quality teams, including Subject Matter Experts (SMEs), and collaborate closely with Engineering, Manufacturing, Regulatory Affairs, IT, and Global Quality.
Implement site-specific quality strategies, ensuring alignment with global policies and regulatory cGMP requirements (FDA, EMA, Health Canada, etc.).
Ensure readiness for regulatory inspections through comprehensive planning, mock audits, and gap assessments.
Conduct practice sessions with key site personnel to have successful interactions with regulatory inspectors.
Requirements
PhD in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 5 years relevant experience.
MS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 7 years relevant experience.
BS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 9 years relevant experience.
Strong grasp of quality risk-based processes and principles.
The position is eligible to participate in the company bonus pool.
There is a requirement for travel for this position. It is expected to have 15% to 50% travel to the other Biopharma sites in scope of support by Quality Operational Readiness. Some of this travel will be international travel.