Position Summary:

The VP, Global Translational QA is responsible for the global planning, strategy and implementation of the global quality systems including organizational resource planning, implementation of technology, and developing and implementing tactical plans throughout all Translational facilities globally to meet Precision’s objectives.

Essential functions of the job include but are not limited to:

• Plan and direct resources and activities of the quality and compliance functions across all facilities globally
• Member of Translation Sciences Leadership team
• Develop and maintain product and service quality audit programs (internal/external) and GxP audit programs for the bioservice facilities
• Collaborate with cross-functional operational and quality staff in other Precision locations globally
• Support QMS integration activities related to new and existing facilities/laboratories
• Support and guide facilitate the Quality Management Systems that support the quality functions of all critical operations including laboratories, clinical trials manufacturing, including commercial diagnostic products, in order to drive continual improvement and enhance customer satisfaction.
• Lead Quality responses to request for information, business development proposals and attend business development meetings as required
• Direct application of the Quality Management Systems in assuring that components and finished products are in compliance with established specifications and regulations. Responsible for release of all products manufactured and results released from commercial diagnostic products. Ensure that performance and quality of products and services conform to established company and regulatory standards
• Ensure participation in project team meetings as a Quality representative and contribute toward development of relevant design control and risk management documentation for commercial diagnostic products
• Host external regulatory agency, client and notified body assessments and inspections (example: FDA, ISO, EMA, CAP). Review and participate in issues and/or decisions related to assessments
• Ensure a technical liaison between Quality and all other functional management groups in terms of operational objectives, with respect to quality. .
• Ensure that quality assurance and compliance resources are capable of providing required consultation and input for new projects, product development and transfer, manufacturing and distribution
• Identify/lead and participate in process and improvement initiatives
• Serve as the site management representative, providing updates to the company leadership regarding status of the quality system, compliance status and performance relating to quality
• Advise staff to help meet established schedules or resolve technical or operational problems
• Plan, promote and organize training activities related to product/service quality, quality assurance, and compliance
• Coordinate with Learning & Development to ensure that all applicable, required training is provided
• Estimate and administer budget schedules and performance standards
• Maintain an up-to-date knowledge in the techniques of quality, and in the company products and process technologies
• Responsible for ensuring periodic management reviews of the quality system are conducted
• Maintains up-to-date knowledge of FDA, EU, MHRA & EMA regulations and applicable worldwide standards and requirements
• Maintain robust CAPA, nonconformance, QMS electronic documentation and complaint management systems
• Work in conjunction with purchasing department to develop supplier partnership opportunities and ensure supplier qualification meet current
• Quality Standards and regulatory requirements
• Travel up to 30% including international
• Other duties as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
• 7 years of supervisory experience
• At least 15 years’ experience working in a Quality driven life science, regulated environment
• Relevant Industry Certification

Other Required:

• Experience interpreting and complying with world-wide cGxPs with an emphasis on GLP, GLCP, FDA QSR, IVDD/IVDR, ISO 13485, ICH, and CLIA
• Ability to lead and manage multiple bioservice facilities globally
• Experience interpreting and complying with GxP , CLIA, IVDR, MDR and ISO standards
• Experience with managing pre and post market requirements for in vitro diagnostic products in conformance with appropriate regulations and standards
• Experience auditing and interacting and relationship building with the public (regulators, vendors and clients)
• Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in
• Able to travel both domestically and internationally including overnight stays
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Master’s degree in Physical, Biological Sciences, or technical/scientific field
• American Society for Quality certification
• Minimum 15 years of applicable Quality experience with in vitro diagnostics