Director, Regulatory Compliance

The Director, Quality Assessment, plays a critical role in ensuring Quest Diagnostics' products, processes, and facilities meet regulatory requirements and quality standards by assessing quality & regulatory compliance activities for all Quest Diagnostics laboratories to ensure compliance with government, accreditation body, state and local regulatory and quality standards, Good Manufacturing Practices (GMP) and Quest Diagnostics policies.

While this is a remote eligible role, the ideal candidate will be near site to one of the Quest Diagnostics locations. Possible near site locations:

• West Hills, CA
• San Juan Capistrano, CA
• Lewisville, TX
• Irving, TX
• Tampa, FL
• Atlanta, GA
• Wood Dale, IL
• Lenexa, KS
• Denver, CO
• Marlborough, MA
• Pittsburgh, PA
• Clifton, NJ
• Chantilly, VA
• Las Vegas, NV

• Support the Quality & Regulatory Affairs team in designing and developing compliance programs using a risk-based approach.
• Maintain knowledge, review and interpretation of laboratory/device domestic and global regulatory and quality requirements, as applicable to include but not limited to FDA (21 CFR 809/820/210/211/Part 11), GMP/GLP/GCP regulations, ISO (13485/15189), global regulations (Health Canada, MDR, IVDR) as well as Quest Diagnostics policies.
• Perform internal audits to assess compliance with domestic, global and regulatory requirements for pharmaceuticals, medical devices, laboratory developed tests, etc. at all applicable Quest Diagnostics owned and/or managed laboratories.
• Compose and submit timely and accurate inspection reports for corresponding inspections.
• Manage/Approve inspection responses to ensure completeness and accuracy.
• Prepare for and/or assist during regulatory/client inspections and respond to critical/major nonconformities from a notified body, FDA 483, FDA warning letters, and/or other regulatory inquiries, as required.
• Ensure laboratory and laboratory personnel are trained and prepared to successfully support regulatory audits and interact appropriately with external auditors.
• Identify non-conformances and assist local laboratory QA in root cause analysis (RCA), implementing corrective and preventative actions (CAPAs) and ensuring effective corrective actions for compliance gaps.
• Support quality risk management processes to minimize compliance risks and participate in quality and regulatory compliance monitoring activities, as required
• Monitor and escalate risks in quality & regulatory compliance programs to appropriate leadership as necessary.
• Provide communication to the laboratories on relevant quality and regulatory compliance issues.
• Collaborate with National Laboratory Operations and Business Transformation teams, as necessary.
• Serve as a resource and subject matter expert (SME) to laboratories for quality and regulatory compliance issues.
• Maintain systems and processes to assess and update audit protocols and checklists based on regulation or standard changes
• Improve compliance posture through establishment and monitoring of metrics
• Support the design, standardization, governance, and continuous improvement of audit management process and associated electronic tools.
• Prepare written communications, deliver presentations and provide on-site consultations on quality and/or regulatory compliance issues to laboratories and leadership as required.
• Support and participate in special company-wide projects, QMS projects, as required.
• Participate in annual continuing education and company training, as designated.
• Foster a positive culture of quality and serve as a change champion.

• Bachelor's degree in Life Sciences, Medical Technology, Bioscience or related field. Masters degree preferred.
• 5+ years experience in a quality & regulatory-based role conducting audits and ensuring inspection readiness to global and domestic laboratory/device regulations (i.e., FDA, GMP, IVDR, ISO)
• 3+ years in leading Quality, Compliance or Regulatory audit teams in a life science/clinical / lab environment
• 3+ years supporting audit management technology at an enterprise level
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  Sig Sigma Certification- preferred

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  ASQ Certified Quality Auditor- preferred

• Knowledge of FDA (21 CFR 809/820/210/211, Part 11), GMP/GLP/GCP regulations, ISO (13485/15189), global regulations (Health Canada, EU MDR,IVDR)
• Knowledge of ISO 19011: Guidelines for auditing management systems
• Proficient in Microsoft Word, Excel, Outlook, etc.
• Possesses excellent communication (verbal and written), influencing, and collaboration skills
• Ability to work independently and effectively plan/organize work andprojects
• Demonstrate team building and critical thinking skills
• Experience utilizing AI tools
• Travel between 25-50% of the time