Precision for Medicineis the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Director of Quality Assurance?
Position Summary:
This Director of Quality Assurance (Bioservices) role is responsible for planning and implementing the quality systems strategy including organizational resource planning, implementation of technology, and developing and implementing tactical plans to meet Company 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.
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
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:
Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
10-12 years’ experience working in a Quality driven life science, regulated environment
5 years of supervisory experience
Relevant Industry Certification(s)
Other Required:
Experience interpreting and complying CLIA, CAP, 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 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
