Global Quality Systems Lead: Document Management & Training

Quest Diagnostics; Marlborough (MA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical/Prescription Drugs

Dental

Vision

Flexible Spending Accounts (FSAs)

401(k) Plan – Company match dollar-for-dollar up to 5%

Employee Stock Purchase Plan (ESPP)

Paid time off / Health Time

Job summary

A leading diagnostics company in Massachusetts seeks a Senior Manager, Quality Systems to oversee global process design and compliance. The role involves developing global policies aligned with regulatory standards and driving process maturity. Candidates should have over 8 years of experience in Quality Assurance, plus strong leadership in regulated environments. This position offers a hybrid work schedule and a competitive salary range of $110,000 – $160,000 annually.

Qualifications

• 8+ years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance.
• 3+ years in a regulated healthcare, life sciences, or diagnostics environment.
• In-depth knowledge of GxP, FDA, CLIA, and other relevant regulatory frameworks.

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.
• Establish and drive a global roadmap for process maturity, automation, and integration.

Skills

Microsoft Office 365

Technical / Procedural Writing

Education

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

Tools

MasterControl

Veeva

Medialab

Smartsolve

Job description

A leading diagnostics company in Massachusetts seeks a Senior Manager, Quality Systems to oversee global process design and compliance. The role involves developing global policies aligned with regulatory standards and driving process maturity. Candidates should have over 8 years of experience in Quality Assurance, plus strong leadership in regulated environments. This position offers a hybrid work schedule and a competitive salary range of $110,000 – $160,000 annually.