Role OverviewThe Director, External Manufacturing Regulatory Compliance Oversight, provides independent regulatory compliance oversight, risk visibility, inspection-readiness support, governance, and organizational learning across the Innovative Medicine External Manufacturing network.
What You Will Do
Monitor and assess significant compliance risks across assigned external manufacturing partners, identify emerging risk signals, and conduct independent risk assessments.
Why It Might Be a Fit
This role requires a strong understanding of global GMP regulations and external manufacturing compliance requirements, as well as the ability to identify and communicate complex compliance risks in a clear and actionable manner.
Requirements
- Bachelor's Degree in Life Sciences, Engineering, Pharmacy, or related scientific discipline
- Minimum 12 years of pharmaceutical, biotechnology, biologics, advanced therapy, medical device, or combination product GMP experience
- Minimum 5 years of leadership experience in Quality, Compliance, Regulatory Compliance, Supplier Quality, or External Manufacturing
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Dental insurance
- Vision insurance
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
- This position is eligible to participate in the Company’s long-term incentive program
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