Thermo Fisher Scientific Director, Quality/Regulatory Affairs in Middletown, Virginia

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

The Director, Quality and Regulatory Affairs will lead, manage and actively participate in the CDR business unit with an emphasis on maintaining the effectiveness/compliance of the quality system and regulatory compliance of products. Serve as Management Representative with overall accountability for quality system and compliance. Lead Quality Assurance, Quality Control and Quality Systems functions. Determine regulatory strategy for new products and new market introductions. Prepare FDA 510(K), PMA, and IDE, Japanese, European and worldwide submissions. Act as a liaison between other departments, especially international and OEM businesses, regarding quality standards, current global regulations, best practices, GMP and operating procedures. Provide vision, goals, policies and procedures for the Quality/Regulatory organization in support of Quality Policy, mission and goals of both the CDR business unit/Thermo Fisher Scientific.

What will you do?

  • Establish annual site Quality/Regulatory goals and objectives as part of annual Quality Improvement Plan.

  • Manage the preparation of financial, organizational, and facility plans for the QA/RA departments.

  • Interface with applicable regulatory agencies and corporate divisions/departments, maintaining up-to-date knowledge providing business unit guidance/awareness of regulatory/quality policies and procedures.

  • Provide regulatory and compliance expertise and interpretation to personnel or in situations requiring such expertise.

  • Work directly with Customer Quality and Regulatory departments/teams to effectively resolve quality/regulatory issues and remove internal roadblocks. Participate in customer site and business reviews.

  • Serve as CDR site Management Representative. Host agency, ISO and customer audits, and conduct management review. Maintains overall accountability for site quality and compliance.

  • Participate in the product development process in support of new product development efforts to ensure that goals and objectives and customer expectations are met.

  • Participate in new product design reviews to ensure compliance with design controls and that products meet customer expectations.

  • Translate knowledge acquired with current products in the field into product and process improvements.

  • Chair site Risk Management Board and has overall accountability for site product risk management.

  • Actively partner with Operations, Facilities, Engineering and Product Development to create and maintain efficient, effective and compliant systems and processes.

  • Actively manage the relationship with the FDA and other regulatory agencies; leverage the relationship with the FDA and other agencies to eliminate delays in product clearances and approvals.

  • Oversee support for US and international country product registrations on a continuous basis including Certificates of Foreign Government and Certificates of Export; maintain the IEDB import/export database and ensure compliance with NAFTA and CAFTA requirements.

  • Manage key quality systems such as complaint handling and CAPA systems including responsibility for any and all FDA reportable events and recalls.

  • Manage the database of Action Items, CAPAs, and Effectivity Checks. Chair the Material Review Board and disposition discrepancy reports; participate on the Design Control and Change Review Board.

  • Motivate, develop, and retain a staff of skilled professionals who contribute to achieving the objectives and goals of the QARA organization and the CDR business.

  • Develop and maintain a flexible organization such that fast changing manufacturing priorities can be accommodated with a minimum of disruption and bottlenecks.

  • Participate in and represent CDR on corporate and divisional quality and regulatory project teams; other duties as assigned.

How will you get here?

  • B.A. or B.S. degree in Engineering, Science or Life Sciences discipline; M.S. or Ph.D. preferred.

  • Ten (10) years of experience in Quality Assurance/Regulatory is required, with at least four (4) years of proven management experience.

  • Proven experience in establishing positive relationships with FDA and other regulatory agencies.

  • Enable a proactive and preventive approach to employee awareness, facility compliance and quality systems.

  • Make independent decisions on regulatory/quality issues ensuring policy compliance.

  • Position requires a high degree of independent prioritization, review and approval of work.

  • Working knowledge of QA principles and regulations, including Good Laboratory (GLP) and Good Manufacturing Practices (GMP) and broad understanding of technical aspects, as applicable to a medical device manufacturing facility.

  • Diverse knowledge of Diagnostics Quality Assurance, Regulatory, and Manufacturing Operations and be able to relate these to applicable regulations and implement compliance through superiors, peers and subordinates.

  • Able to communicate clearly and effectively with internal and external contacts, superiors, peers and subordinates.

  • Able to review practices, systems/needs, and relate these to current regulatory requirements while implementing changes or program improvements to achieve compliance.

  • Able to respond to regulatory agencies on issues of compliance, permits required and information about the facility.

  • Position requires strong organization, communication, leadership, and management skills to direct diverse, multi-disciplinary functions.

  • IVD industry experience and ASQ/RAPS certification preferred.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.