Director, Quality Assurance Jobs

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 through all bioservice facilities to meet Company objectives.

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

• Provide oversight to site specific quality leadership team
• Provide oversight of the global Quality Management Systems that support the quality functions of all critical operations including laboratories, supplier qualification, clinical trials manufacturing, including commercial diagnostic products
• Provide input budget schedules and performance standards
• Coordinate with Learning & Development to ensure that all applicable, required training is provided as related to product/service quality, quality assurance, and compliance
• 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
• Lead Quality responses to request for information, business development proposals and attend business development meetings as required
• Other duties as assigned
• Maintain robust CAPA, nonconformance, QMS electronic documentation and complaint management systems
• Collaborate with cross-functional operational and quality staff in other Precision locations globally
• Provide updates to the company leadership regarding status of the quality system, compliance status and performance relating to quality
• Serve as Management Representative designee responsible for ensuring periodic management reviews of the quality system are conducted
• Host/support 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
• Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements
• Travel up to 30% including international
• Schedule and manage process and equipment validations and re-validation in accordance with established Standard Operating Procedures
• 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.
• Plan and direct resources and activities of the quality and compliance functions across all facilities globally.
• Ensure a technical liaison between Quality and all other functional management groups in terms of operational objectives, with respect to quality.
• Identify/lead and participate in process improvement initiatives and continue the alignment of the global quality systems across the sites

Qualifications

Minimum Required:

• Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
• Relevant Industry Certification
• 5 years of supervisory experience
• 10-12 years’ experience working in a Quality driven life science, regulated environment

Other Required

• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in
• Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
• Ability to lead and manage a global quality team
• Able to travel both domestically and internationally including overnight stays
• Experience interpreting and complying GLP, GLCP, FDA QSR, ISO 13485, ISO 9001, ICH, as well as awareness of CLIA
• Must be able to read, write, speak fluently and comprehend the English language
• Experience auditing and interacting and relationship building with the public (regulators, vendors and clients)

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$140,000 — $190,000 USD

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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