The Senior Director, Quality Assurance is responsible for Quality and Regulatory compliance related to GMPs, pharmaceuticals and devices. The Senior Director, QA will ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines. This is a global position that reports to the Vice President, Quality and is based at our Bridgewater, New Jersey headquarters location.
• Establish and maintain a risk- and scientific-based Quality System.
• Through a Quality System approach, ensure all GMP and device-related operations are compliant, while maintaining an efficient workflow to facilitate operational excellence.
• Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriate.
• Oversee and be ultimately responsible for the Quality Assurance Program; this includes overseeing and assisting with training and auditing programs, as well as the review of SOPs, investigations, validation reports and regulatory agency inspections.
• Manage vendor quality by executing a vendor quality management program including quality agreements and periodic assessment of vendor performance metrics.
• 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 the Company’s representative during regulatory agency and customer/partner inspections.
• Identify and lead operational excellence initiatives, both in the QA Department and Company-wide, which result in the overall improvement in both areas.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department.
• Audit the facilities of vendors, customers and outside contract organizations.
• Approximately 30% travel, domestic and international in nature.
- Minimum BS degree in Life Science or related discipline and more than 10 years of equivalent experience in a regulated industry such as pharmaceutical, biologics or device required. RPh,/PharmD degreepreferred.
- Full understanding of GMPs and the pharmaceutical development process is required.
- A good understanding / familiarity with GLPs and GCPs is essential.
- Experience with, and good understanding of, FDA and other key regulatory agency inspection procedures, inspection preparation & management, and addressing inspectional findings is also required.
- Experience with Phases I thru IV (particularly Phase III); experience with regulatory approval, NDAs and MAAs.
- Experience with the pharmaceutical development process, as well as the transfer of processes and methods from research to development, and from development to scale-up and commercialization is necessary.
- Solid experience with effectively managing FDA and other regulatory agency inspections, working with regulators, and vendor audits essential.
- Broad knowledge of risk-based Quality Systems required.