Position Summary:

The Quality, Manager Assurance is responsible for building, implementing, and maintaining quality assurance systems and processes that comply with FDA (IVD) and GxP requirements. This individual will oversee and execute all aspects of the strategic quality plan across cGxP applications and quality system functions. This role will interface with internal teams, clients, regulators, and other Precision for Medicine facilities.

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

• Collaborate with operational and quality staff in other Precision locations to execute harmonization plans for global processes and procedures
• Plan and direct resources to manage the quality assurance and compliance functions in conjunction with the Director Quality Assurance
• Responsible for aligning global practices, promoting improvement, leading and maintaining compliance, and measuring and reporting on performance and effectiveness through established metrics and KPIs
• Lead inspection readiness activities
• Host external client audits in addition to assessments and inspections conducted by regulatory agencies and notified bodies (example: FDA, CAP). Review and participate in issues and/or decisions related to assessments
• Manage the Quality System and support the quality functions of all critical operations
• Create/revise/coordinate-controlled document system
• Review and approve quality system activities (including but not limited to Deviation, Non-Conformances, Customer Complaints, CAPA, Audits, Validation, Qualification, Equipment, Review and Disposition of final product/data)
• Contribute to the evaluation and mitigation of program risks and escalation of potentially significant quality issues
• Participate in cost reduction and improvement programs
• Support the training program by promoting training activities related to operations, quality assurance, Safety, and compliance
• Maintain an up-to-date knowledge in the techniques of quality and in the company products/services and process technologies
• Responsible for ensuring management reviews of the quality system are conducted
• Maintains up-to-date knowledge of regulations and applicable worldwide standards and requirements
• Participate actively as a permanent safety committee member
• Schedule and manage the review of computer systems, process and equipment validations and re-validation in accordance with established Company policy. Review validation protocols and reports and ensure compliance with all relevant Quality Standards and regulatory requirements
• Work in conjunction with purchasing department to develop supplier partnership opportunities and ensure supplier qualifications meet current Quality Standards and regulatory requirements
• Other duties as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
• 5 – 8 years of experience as a Quality professional in the biotechnology or life science, regulated environment
• Successful ISO13485 accreditation (direct involvement with accreditation activities) and 21 CFR Part 820
• Must have first-hand experience with Design Control and associated Design History File and supporting post-market effort surveillance.

Other Required:

• Excellent knowledge of medical research processes, laboratory testing protocol, and safety requirements
• Strong understanding of medical data collection, record keeping, and reporting requirements
• Experience interpreting and complying with world-wide cGxPs with an emphasis on CAP/CLIA , GMP, GCP, GLP, GCLP, and ISO 15189
• Experience auditing and interacting and relationship building with the public (vendors and clients)
• Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
• Extended business hours may be necessary in order to meet the business demands
• This position will require occasional domestic or international travel, including overnight stays (up to 20%)
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in
• 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
• ASQ or SQA certification desirable