Job Summary:The Executive Director of Quality Control will be responsible for all aspects of quality control from drug development through commercialization, including the manufacture of clinical products, conduct of 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 Gx P regulations.
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, allocate budget for 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 guidance and 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, and finished product manufacturing and packaging, QC release and stability testing, and final lot disposition.
- Ensure adherence to GMPs, GLPs, GCPs and GDPs.
- 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.
- Chair Senior Management review of quality control metrics.
- Build, coach, mentor and ensure appropriate management development for key personnel in his/her department
EDUCATIONMinimum required:
- Bachelor of Science degree in sciences/engineering with at least 15 years of related experience
OR:
- D. in relevant scientific discipline such as biochemistry, chemistry, pharmaceutical sciences or related field with at least 5 years of related experience.
EXPERIENCE- 15+ years of progressive experience in the biotechnology or pharmaceutical industry.
- 5+ years in related field at a senior level and leadership position.
KNOWLEDGE, SKILLS AND ABILITIESMinimum required:
- Global GxP regulatory experience.
- Respected senior development executive in the bio-pharmaceutical field
- Have a strong record of accomplishment in quality, as demonstrated by successful regulatory approvals of drug candidates under his/her responsibility during development.
- Be able to develop/communicate a compelling vision/ sense of purpose for the function/organization and work collaboratively to formulate long-range and mid-term strategies.
- Possess excellent oral and written communication skills.
- Be a 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.
Preferred:
- Experience with JMP statistical software
- Experience with cell-based potency assays
What Revance invests in you:- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
