Senior Manager, Quality Systems (Hybrid - open to various lab locations)
About The Position
The Senior Manager, Quality Systems supports the global design, standardization, governance, and continuous improvement of core quality system processes across business units and geographies. The role ensures quality processes are effective, compliant, and aligned with regulatory requirements and business objectives. Reporting to the head of Global Quality Systems, this position partners cross-functionally to advance harmonization, digital enablement, and operational excellence across Quest’s global quality landscape. The role is hybrid, with a primary hiring location in Marlborough, Massachusetts. Candidates residing near other major Quest labs may also be considered, including Pittsburgh, Houston, Lenexa, Dallas, Wood Dale, Tampa, Chantilly, Clifton, and San Juan Capistrano.
Requirements
- At least 8 years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance, including at least 3 years in a regulated healthcare, life sciences, or diagnostics environment.
- At least 3 years of global or local process ownership or project leadership experience.
- Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field.
- In-depth knowledge of GxP, FDA, CLIA, and other relevant regulatory frameworks.
- Microsoft Office 365 skills.
- Proficiency in technical and procedural writing.
Nice To Haves
- Experience in Quality and Regulatory Affairs within diagnostics, medical devices, or laboratory services.
- Working knowledge of enterprise systems such as MasterControl, Veeva, Medialab, or Smartsolve.
- Demonstrated ability to lead change in a regulated environment.
- ASQ or ISO certification.
- Master’s degree.
Responsibilities
- Support development of global policies, procedures, and standards aligned with ISO, FDA, CLIA, CAP, and other applicable regulations.
- Support a global roadmap for process maturity, automation, and integration with other quality and business processes.
- Monitor performance and compliance of KPIs and process health metrics through dashboards, audits, and reviews.
- Partner with Regulatory Affairs to assess emerging regulations and ensure proactive compliance.
- Drive adoption of global standards and behavioral alignment as a change agent.
- Collaborate with the Global Process Owner (GPO) to develop training materials and deploy role-based training for quality system processes.
- Partner with the GPO, IT, and QARA project management teams to define user and functional requirements and enable process automation.
- Support system configuration, validation, and integration projects that affect quality processes.
- Engage with GPOs, Site Quality leaders, Operations, R&D, IT, Legal, and other stakeholders to promote global process alignment and effectiveness.
- Participate in global communities of practice and user forums for continuous feedback and best-practice sharing.
- Participate in corporate and/or health authority inspections and audits when local subject matter experts have not been able to satisfy auditor requests or questions.
Benefits
- Day 1 medical, supplemental health, dental, and vision coverage for full-time employees working 30 or more hours.
- Well-being programs.
- Annual no-cost Blueprint for Wellness health assessment program.
- healthyMINDS mental health program.
- Vacation and Health/Flex Time.
- Six holidays plus one “MyDay” off.
- FinFit financial coaching and services.
- 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service.
- Employee stock purchase plan.
- Life and disability insurance, with buy-up option.
- Flexible Spending Accounts.
- Annual incentive plans.
- Matching gifts program.
- Education assistance through MyQuest for Education.
- Career advancement opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
