Associate Director, CMC Quality Assurance

About the role

Reporting to the Senior Director, CMC Quality Assurance, the Associate Director, CMC Quality Assurance is responsible for directing all quality related activities and processes for product in clinical phase studies. This includes but not limited to supplier relationships/audits, batch review/release, site transfers, and internal document set up/review, QMS, weekly team meetings for drug substance, drug product, packaging and labeling. In addition, you will be responsible for facilitating transition from drug development to commercial product.

Responsibilities

• Audit the manufacturing facilities of vendors, customers and outside contract organizations.
• Facilitate and approve Quality Technical Agreements with vendors.
• Through a quality-system approach, ensure phase appropriate GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
• Apply phase appropriate GMP compliance principles to quality decisions.
• Lead investigations, CAPAs, deviations and quality events to resolution and closure.
• Transition phase 3 clinical stage material to commercial success.
• Manage all quality aspects of phase 1 through phase 3 clinical projects from raw materials to manufacturing to packaging, distribution and release.
• Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development.
• Be responsible for release or rejection of GMP materials and utilize QA staff to manage the timeline and assure on time delivery of approved materials.
• Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, customers or to support the quality assurance function.
• Provide support and training to other staff members to develop additional auditing resources.
• Act as company’s representative during regulatory agencies and customer inspections.
• Identify and lead operational excellence initiatives, both in the department and companywide.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department.

Qualifications

• Minimum of a BS degree in Chemistry, Life Science or related discipline.
• MS, PhD, MBA and more than 7 years of equivalent QA experience in regulated industry such as pharmaceutical, biologics or device.
• In lieu of advanced degree 10 or more years equivalent experience will be considered.
• Demonstrated ability to manage staff and projects (direct and indirectly) and variable workloads.
• Full understanding of cGMPs, GLPs and a working knowledge of GCPs.
• Understanding of device regulations and development processes.
• Familiarity of pharmaceutical product manufacturing processes, small molecule and biologics.
• Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs.
• Experience with effectively managing FDA inspections, working with regulators, and customer audits.
• Experience at writing manufacturing and lab investigations.
• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.