About the company
Our partner is looking for a Senior Director, GMP Quality Assurance based in the United States.
Responsibilities
- Lead pharmaceutical quality systems: Develop, implement, govern, and continuously improve the pharmaceutical quality system.
- Oversee external manufacturing and testing.
- Manage product disposition and release.
- Review and approve quality documentation.
- Support product and process lifecycle activities.
- Manage external partner quality.
- Establish quality agreements.
- Monitor quality performance and risks.
- Lead inspection readiness.
- Protect data integrity.
- Manage critical quality events.
- Support strategic business activities.
- Manage resources and budgets.
- Build a high-performing Quality organization.
- Exercise independent Quality authority.
Requirements
- Education: Bachelor's degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline. An advanced degree is preferred.
- Industry experience: At least 15 years of progressively responsible Quality experience in the pharmaceutical or biotechnology industry.
- Outsourced operating models: Demonstrated experience leading Quality within a fully or substantially outsourced environment.
Conditions
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