Director, Quality Assurance (Bioservices)

Position Summary:

This Director of Quality Assurance (Bioservices) role is responsible for implementing and maintaining the quality systems including organizational resource planning, implementation of technology, and developing and implementing tactical plans to meet Company objectives. This position is also responsible for supporting the product quality strategy for Precision for Medicines regulated diagnostic and companion diagnostic product portfolio.

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
• Provide oversight to site specific quality leadership team
• Identify/lead and participate in process improvement initiatives and continue the alignment of the global quality systems across the sites
• Provide updates to the company leadership regarding status of the quality system, compliance status and performance relating to quality
• Collaborate with cross-functional operational and quality staff in other Precision locations globally
• Provide oversight of the global Quality Management Systems that support the quality functions of all critical operations including laboratories, supplier qualification, clinical trials, including commercial diagnostic products
• Support the quality functions related to FDA QSR, IVDD/IVDR, ISO 13485 and ISO 15189
• Responsible for release of all products manufactured and results released from commercial companion diagnostic products
• Support post-market surveillance activities for in vitro companion diagnostic products
• Support pre-market activities including design control and risk management of medical devices by authoring and reviewing appropriate documentation. Provide guidance to the CDx team
• 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 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/support external regulatory agency, client and notified body assessments and inspections (example: CLIA, CAP, FDA, ISO, EMA)
• 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
• Serve as Management Representative designee responsible for ensuring periodic management reviews of the quality system are conducted
• Coordinate with Learning & Development to ensure that all applicable, required training is provided as related to product/service quality, quality assurance, and compliance
• Provide input budget schedules and performance standards as needed
• Schedule and manage process and equipment validations and re-validation in accordance with established Standard Operating Procedures
• Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements
• Maintain robust CAPA, nonconformance, QMS electronic documentation and complaint management systems
• Travel up to 30% including international
• Other duties as assigned

Qualifications:

Minimum Required:

• Bachelors degree in physical, Biological Sciences, or technical/scientific field
• 10-12 years experience working in a Quality driven life science, regulated environment with hands-on experience on supporting medical device pre- and post-market activities.
• 5 years of supervisory experience
• Relevant Industry Certification(s)

Other Required:

• Experience interpreting and complying CLIA, CAP, GLP, GLCP, FDA QSR, ISO15189, ISO 13485, ICH
• Ability to lead and manage a global quality team
• 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 drivers 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