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Vice President of Quality and Compliance
2 months ago
The Vice President of Quality and Compliance will be responsible for leading the global quality operational management of the GMP facilities in the United States and Europe.
Key Responsibilities- Develop and implement quality strategies to ensure compliance with global GMP regulations.
- Manage quality teams in both Bloomington and Halle, ensuring effective communication and collaboration.
- Establish and maintain surveillance processes for all deficiencies and observational themes in the global regulatory environment.
- Collaborate with regulatory agencies, such as the FDA and EMA, to ensure compliance and resolve any issues.
- Perform quality and compliance internal corporate audits to ensure adherence to company standards.
- Interact with product development groups to manage and submit regulatory filings for customers and internal needs.
- Redact and review responses to regulatory bodies that have conducted audits at company sites.
- Minimum of 12+ years of experience in pharmaceutical manufacturing, packaging, or laboratory experience, including at least 10 years in clinical and commercial quality operations.
- Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to parenteral drug products.
- Strong knowledge of current industry trends and ability to use the latest technologies.
- Working knowledge of aseptic practices and clean room design/operations, auditing techniques.
- Strong leadership skills with the ability to thrive in a high-throughput environment.
- Ability to lead and manage projects/teams within corporate objectives and project timelines.
- Appreciation and desire to operate within a completely digital GMP environment.
- General knowledge of quality systems and compliance.
- Greater than 10 years of experience in the field.
B.S. degree required in Science or Engineering with an advanced degree preferred.
Benefits- Day One Benefits Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance Spouse Life Insurance
- Child Life Insurance
- Short and Long-Term Disability Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Additional Benefits Voluntary Insurance Benefits Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities Workout Facility
- Cafeteria
- Credit Union
