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.

• Bachelors 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

• Sig Sigma Certification- preferred

• 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 MDRIVDR)
• 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