Director of Quality Systems

JOB FUNCTIONDirect, plan, administer, and provide Leadership for the activities of personnel in Quality Systems ( Quality Control, Quality Documentation, Inspection, Compliance, Quality Systems, FDA). Develop and authorize the implementation of site policies and procedures to assure compliance with government requirements, and corporate policies. Participate as a member of the site Senior Management Team developing site strategies, policies, and successfully implementing the same. Represent company at the Director level with regulatory agencies.ESSENTIAL DUTIES AND RESPONSIBILITIES 1.  Site Compliance: ensure site is compliant with applicable quality and regulatory requirements. Manage FDA and Customer Audits and CAPA.2. Testing and Product Disposition: assure that all testing is conducted in a timely fashion and within an approved, established framework. Ensure that each finished product’s disposition reflects commitments to integrity and quality.3. Validation: generate functional, technically sound validation plans/protocols (process and cleaning) which assure reliable and consistent process when placed into the on-going operation.4. Stability Program: Assure the timely testing and prompt evaluation of data generated through testing. 5. Procedures: assure that procedures (SOPS and operating instructions) are available, and administer the documentation program for review and approval.6. Complaints and Excursions: investigate customer/consumer complaints and in-house generated excursions (process, technical, etc.). Establish probable cause, to minimize potential impact, and/or reveal opportunities for improvement in operations and manage associated CAPA..7. Budgets: Develop and manage budgets for the Quality Team supporting business initiatives and strategies.
 OTHER: 3 direct reports; 80 +  indirect reports, and reports to the VP Quality EDUCATION and/or EXPERIENCEEducation: Bachelors degree, at minimum, in the Sciences. Advanced degree a plus. Experience: Wide-ranging QA/QC managerial skills, including laboratory management, and a minimum of 10 years experience and hands-on work. This experience should encompass Rx Pharmaceuticals, including NDA filed products Thorough knowledge of FDA regulations and involvement in establishing plant-wide quality systems also required.