Director Quality Systems

Reporting to the head of VP Chief Laboratory Officer the Director Quality Systems is responsible for the global design standardization governance and continuous improvement of the core CAPA and Nonconformance process across all business units and geographies. This position ensures that the processes are effective compliant and aligned with both regulatory requirements and business Director Quality Systems partners cross functionally to drive harmonization digital enablement and operational excellence across Quests global quality landscape.

Position may work out (hybrid) of one of the following Quest sites:

West Hills CA or San Juan Capistrano CA

Lewisville TX or Irving TX

Tampa FL or Atlanta GA

Wood Dale IL Lenexa KS Denver CO

Marlborough MA Pittsburgh PA

Clifton NJ Chantilly VA

• Own end to end global process design and performance for CAPA and Nonconformance quality system elements.
• Develop global policies procedures and standards in alignment with ISO FDA CLIA CAP and other applicable regulations.
• Establish and drive a global roadmap for process maturity automation and integration with other quality and business processes.
• Define KPIs and process health metrics; monitor performance and compliance through dashboards audits and reviews.
• Serve as the primary decision maker for global process-related escalations deviations and change initiatives.
• Partner with Regulatory Affairs to assess the impact of emerging regulations and ensure proactive compliance.
• Lead change management efforts to drive adoption and behavioral alignment with global standards.
• Collaborate and develop training materials and deploy role-based training content for the process.
• Partner with IT and e-QMS project management teams to define user and functional requirements and enable process automation.
• Support system configurations validation and integration projects that impact the quality process.
• Serve as the approver on CSV validation documents ensuring Part 11 compliance
• Engage with Site Quality leaders Operations R&D IT Legal and other stakeholders to ensure global process alignment and effectiveness.
• Facilitate global communities of practice and user forums for continuous feedback and best practice sharing.
• Participate in corporate and/or health authority inspections/audits when local SMEs have not been able to satisfy auditor requests or questions.
• Serve as owner and business system administrator of technology tool.

Required WorkExperience:

• 10 years of experience in Quality Assurance Quality Systems or Regulatory Compliance with at least 3 years in a regulated healthcare life sciences or diagnostics environment.
• 3 year of experience of global or local process ownership or project leadership experience.

Preferred Work Experience:

• Experience in Quality and Regulatory Affairs within the diagnostics medical devices or laboratory services industry.
• Working knowledge of enterprise systems such as MasterControl Veeva Medialab Smartsolve etc.
• Demonstrated ability to lead change in a regulated environment

Knowledge:

• In depth knowledge of GxP FDA CLIA and other relevant regulatory frameworks.

Skills:

• Microsoft Office 365
• Proficient in Technical / Procedural Writing
• Root Cause Analysis

Travel required

English required

Education:

• Bachelors degree in Life Sciences Engineering Quality or related field (Required)
• Masters Degree (Preferred)
• ASQ ISO certification (Preferred)