Executive Director, Quality Control

Job Summary:

The Executive Director, Quality Control will be responsible for all aspects of quality control, from drug development through commercialization, including the manufacture of clinical products, conducting clinical trials, oversight of GCP and GLP CROs, and the manufacture/distribution of commercial products globally. This role will also be responsible for leading science-driven, phase appropriate analytical development to support clinical programs to commercial registration and post-approval improvements both internally and at third party contractors.

This position is a broad-based, strategic position requiring a true quality approach to assessing data and problem-solving in accordance with applicable global GxP regulations.

**
Reporting to:**     SVP, Quality & Regulatory
Location:             Newark, CA - hybrid (3 days/week onsite)
Salary range:     $225,000 - $250,000 + annual performance bonus

* the final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education and geographic location.

**
Responsibilities/Essential Duties:**

• Serve as the primary Quality Control (QC) Analytical and Microbiology liaison of the company to US FDA and external US agencies, and ensure Revance is appropriately represented in QC matters.
• Develop resourcing strategies, and allocate the budget for the department to meet company objectives and efficient operations.
• Establish, maintain, and improve all processes within the Microbiology and Analytical Laboratories for both internal and externally tested biological products. QC accountability may extend to other GxP regulated products within Revance (Rx, OTC, medical devices).
• Provide strategic direction for QC analytical and microbiology functions, including environmental monitoring.
• Oversee quality control operations to assure compliance with quality systems, data integrity requirements, and all applicable regulations.
• Provide guidance for phase appropriate in-process, release, and shelf-life specification establishment, and lead review/approval in compliance with applicable global regulations.
• Co-lead with Analytical Development the development, validation, deployment and management of analytical methods, ensuring compliance with applicable ICH guidelines and global regulations.
• Oversee drug substance, bulk drug product, finished product manufacturing and packaging, QC release and stability testing, and final lot disposition.
• Ensure adherence to GMPs, GLPs, GCPs, and GPDs.