Director of Quality - $200K + 30% Bonus – Medical Devices &Sterile Micro Injectables Manufacturing - DUTIES AND RESPONSIBILITIES: Site Compliance: Ensure multi-sites are compliant with applicable quality and regulatory requirements. Support FDA and Customer Audits. Testing and Product Disposition: Assure that all testing (chemical, microbiological, and physical) is conducted in a timely fashion and within an approved, established framework (SOPs, customers’ requirements, etc.). Ensure that each finished product’s disposition reflects commitments to integrity and quality. Validation: Generate functional, technically sound validation plans/protocols (process and cleaning) which assure reliable and consistent process when placed into the on-going operation. Stability Program: Assure the timely testing and prompt evaluation of data generated through testing (chemical and/or micro). Evaluate data to determine the product’s efficacy through its assigned expiration date.
Procedures: Assure that procedures (SOPS and operating instructions) are available, and administer the documentation program for review and approval. 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 (production, laboratories, etc.) and manage associated CAPA. Quality as Profit Center: Develop the logistics for and control of an accurate fee schedule and timely billing for customers (testing, managed stability program, validation, etc.). Review and revise, if necessary, test’s availability and service fees to reflect most current cost and expense of services performed. Budgets: Develop and manage budgets for the Quality Team supporting business initiatives and strategies.
Customer Interface: Develop and maintain relationships with Customers for current and future products.Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
Bachelor's degree in Sciences (chemistry, microbiology) is required. Advanced degree MS/MBA a plus. Minimum 10 years of related experience is required to include laboratory management. Desire experience with any of the following: Medical Devices & Sterile Micro Injectables including NDA filed products. Thorough knowledge of FDA regulations and quality systems also required. Minimum 10 years wide-ranging QA/QC managerial skills are required. Communication skills and the ability to interact with customers and colleagues at all levels are required.