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Quest Diagnostics · 1 month ago

Senior Manager, Quality Systems (Global Process Owner)

Marlborough, MA

Full-time

Hybrid

Senior Level, Lead/Staff

$110K/yr - $160K/yr

8+ years exp

Quest Diagnostics is a leading provider of diagnostic information services. They are seeking a Senior Manager, Quality Systems who will be responsible for the global design, standardization, governance, and continuous improvement of core quality system processes across all business units and geographies.

BiotechnologyHealth CareHealth DiagnosticsInformation ServicesPrecision Medicine

No H1B

Responsibilities

Own end to end global process design and performance for the assigned quality system element

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

Qualification

Quality AssuranceRegulatory ComplianceProcess OwnershipGxP KnowledgeMicrosoft Office 365Technical WritingASQ CertificationISO CertificationChange ManagementProject Leadership

Required

8+ 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

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

Microsoft Office 365

Proficient in Technical / Procedural Writing

Bachelor's degree in Life Sciences, Engineering, Quality, or related field

Travel up to 25%

English Required