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.

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.
• Interact regularly with contract manufacturers and contract testing laboratories.
• Establish and adhere to all quality agreements.
• Provide support for regulatory submissions.
• Manage regulatory agencies (FDA, EMA), and state board health inspections.
• Provide quality support for adverse events and complaints.
• Chain Senior Management review of quality control metrics.
• Build, coach, mentor, and ensure appropriate management development for key personnel in his/her department.

Basic Qualifications

• Bachelor’s degree & 15+ years’ directly related experience; OR
• PhD & 5+ years’ directly related experience.

Preferred Qualifications

• Bachelor’s of Science degree in a Science or Engineering discipline.
• PhD in relevant scientific discipline such as biochemistry, chemistry, pharmaceutical sciences, or related field.
• 15+ years’ progressive experience in the biotechnology or pharmaceutical industry.
• 5+ years’ in related field at a senior level and leadership position.
• Global GxP regulatory experience.
• Respected senior development executive in the bio-pharmaceutical field.
• A strong record of accomplishment in Quality, as demonstrated by successful regulatory approvals of drug candidates under his/her responsibility during development.
• Able to develop/communicate a compelling vision/sense of purpose for the function/organization, and work collaboratively to formulate long-range and mid-range term strategies.
• Possess excellent oral and written communication skills.
• Self-confident, proactive, influential and decisive leader who has the talent to engage other company managers and external affiliations in productive collaborations.
• Experience developing and organizing a budget.
• Broad experience in analytical sciences supporting late-stage and commercial products.
• Strong strategic sense and communication skills with authorities.
• Proven track record with a number of successful marketing applications.
• Experience in development of biological assays.
• Working knowledge of statistics.
• Experience with JMP statistical software.
• Experience with cell-based potency assays.