About this role
Role Overview
- 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.
Benefits
- Medical
- Dental
- Vision
- Life Insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement