Ruderfer & Associates
Biopharmaceutical Search Consultants

#2088

Director, Quality Assurance & Regulatory Affairs - Operations

Position:                     Director, Quality Assurance & Regulatory Affairs - Operations    Job #2088

Location:                    Northern NJ/Virtual

Compensation:          Based Upon Experience

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Job Summary:

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

Qualifications:

  • 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. 

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