Director, Quality Assurance

The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities. The incumbent will be an integral member of the Site Leadership Team. The Director is accountable to ensure that the systems, procedures and practices for pharmaceutical operations at the site comply with policies and the cGMP requirements of all major regulatory agencies that regulate the site (e.g. FDA/EMA, etc.).

Responsibilities

• Leads and oversees Quality Assurance, Quality Control, Stability and related site quality activities, including commercial and development products.
• Quality Lead for regulatory inspections, client audits and the site internal and external audit program. Prepares and approves responses to all external audit findings and oversees direct implementation of corrective and preventative actions (CAPAs).
• Manages the QC team to ensure the availability of materials and testing necessary to meet the scheduled production and the site’s monthly target numbers.
• Directs the QA team to ensure the timely completion of investigations, batch record reviews and batch releases to meet the site’s monthly targeted delivery performance.
• Co-leads the Site Quality Council with Site Head and manages monthly meeting.
• Contributes to the review and implementation of quality agreements with clients, contractors, and suppliers.
• Provides direction on state of quality, quality related issues and quality metrics for the site. Independently identifies and initiates functional and cross-functional projects/task teams on a pre-emptive or as needed basis.
• Identifies and implements various strategic initiatives that drive cost control and cost reductions. Responsible for development of the Quality Unit budget and successful execution to achieve it.
• Review and/or approve deviations, out-of-specification reports, formal investigations, complaint investigations; Corrective Action/Preventative Action (CAPA) program and other reports as necessary.
• Oversees the Quality training team on GMP related employee and contractor training. Ensures the training program adequately provides the guidance, procedures, systems and documentation that demonstrates personnel have the experience and qualifications to perform their job.
• Interfaces with the regulatory team to evaluate product changes and new product introductions at the site to ensure compliance.
• Coaches, councils and mentors staff on job related activities and career development.
• Evaluates quality staffing needs with major fluctuations in production volumes and growth opportunities with technical transfer and development projects. Provides adequate justifications for resources when applicable.

Qualifications

• Bachelor’s degree in the physical sciences or engineering. MS or Ph.D. in scientific or healthcare discipline preferred, but not required.
• 15+ years of Pharmaceutical QA and QC experience, with demonstrated growth in responsibilities and expertise.
• 7+ years of experience managing all aspects of a Quality department and function.
• Proven leadership and development of a staff of quality professionals.
• Detailed knowledge of chemistry and manufacturing/packaging controls.
• Extensive knowledge of cGMP requirements (21CFR Part 211 and/or ICH Q7).