Position: Director, Quality Assurance & Regulatory Affairs - Operations Job #2088
Location: Northern NJ/Virtual
Compensation: Based Upon Experience
This position provides quality oversight and a single and consistent quality approach for our Development and Commercial products globally throughout the product development and commercial lifecycle. The Quality Product position enables consistent and efficient communication and decision-making related to the quality of our products across the global supply chain to occur. The QP acquires and applies product-quality knowledge and acts as the quality expert for assigned products throughout the product lifecycle This individual will be responsible for the maintenance and advisement of Quality Assurance & Regulatory Affairs as it relates to Quality Systems and the associated ISO 13485 standards and certification. This highly committed, results-oriented individual must be innovative and forward-thinking while anchored in ethics and integrity, have demonstrated leadership skills, success in developing, mentoring and managing direct reports and be able to effectively manage the balance between delegation/empowerment and a hands-on approach. The ability to work successfully across functions and cultures is critical.
Duties & Responsibilities:
Represents all of the Global Quality Systems functions on cross-functional project teams to enable quick and effective decision-making and to ensure that the quality of a product meets predefined quality and compliance requirements.
Serves as the single point of contact in the Global Quality System organization for the development and post-approval lifecycle management of assigned products and leads product specific continuous improvement and change management initiatives as per ISO 13485 guidelines.
Serves as the quality expert for the product during clinical development/commercial supply and is responsible for making strategic quality decisions.
Serves as the quality and product expert for the product during the commercial lifecycle and is responsible for making quality-related decisions and playing the role of the liaison between the manufacturing / supply chain and other quality functions
Provides a proactive front-end approach to product quality. Ensures quality and compliance are ingrained and built into the process during pharmaceutical development and commercial supply.
Establishes and tracks product metrics, monitors overall product quality performance and the integrity and quality of the product supply chain, and initiates / leads improvement initiatives to enhance performance and/or mitigate quality or compliance risks
Leads multi-site/multi-function risk management programs for assigned products and is accountable for the completion of risk mitigation activities
Participates in and supports complex deviation investigations, Material Review Boards, Change Management, Specification Committee, critical quality complaint resolution activities for assigned products
Leads the creation of the Annual Product Review / Product Quality Review and other product-specific quality documents as required. Support regulatory filings, inspections and compliance audits for assigned products.
Creates and maintains product and process knowledge database and transfers knowledge to site and regional employees
Support, as required, customer complaints, and non-conformance.
Support CAPA process\systems
Bachelor’s Degree in Pharmacy, engineering, chemistry or related life sciences field. Advanced degree is preferred.
A minimum of 15 years related experience in a regulated industry and device and Pharmaceutical Industry, a minimum of 10 years in a GMP and/or pharmaceutical environment.; minimum of 5 years related experience in pharmaceutical product development.
Knowledge of ISO 13485, MDD, FDA, EMEA and other regulatory agency requirements, regulations and industry guidance with demonstrated experience interacting with health authorities.