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Quality Assurance Risk Manager Jobs in Boston, MA

Drive risk management initiatives, CAPA programs, and deviation investigations to ensure timely ... Quality Assurance experience within the biotechnology or pharmaceutical industry, including ...

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Quality Assurance Risk Manager information

See Boston, MA salary details

$41.3K

$128.3K

$194.5K

How much do quality assurance risk manager jobs pay per year?

As of Aug 23, 2026, the average yearly pay for quality assurance risk manager in Boston, MA is $128,275.00, according to ZipRecruiter salary data. Most workers in this role earn between $90,200.00 and $157,000.00 per year, depending on experience, location, and employer.

What is the difference between Quality Assurance Risk Manager vs Quality Control Specialist?

AspectQuality Assurance Risk ManagerQuality Control Specialist
CertificationsISO 9001, Six Sigma, CQEISO 9001, Six Sigma, CQE
Work EnvironmentRisk assessment, process improvement, complianceProduct inspection, testing, defect identification
Industry UsageManufacturing, healthcare, aerospaceManufacturing, food production, electronics

The Quality Assurance Risk Manager focuses on identifying and mitigating risks in processes to ensure quality standards are met, often involving risk assessments and compliance. In contrast, the Quality Control Specialist primarily conducts product inspections and tests to detect defects. Both roles require similar certifications and are integral to quality management but differ in scope and focus.

What is quality assurance in risk management?

In the context of a Quality Assurance Risk Manager, quality assurance in risk management involves systematically identifying, assessing, and mitigating potential risks that could impact product quality or operational processes. It includes implementing standards, conducting audits, and using tools like risk assessments to ensure compliance and reduce errors, thereby maintaining product integrity and customer satisfaction.

What cities near Boston, MA are hiring for Quality Assurance Risk Manager jobs?

Cities near Boston, MA with the most Quality Assurance Risk Manager job openings:

Analytical Quality Assurance, Associate Director

Vertex Pharmaceuticals Inc (US)

Boston, MA • On-site

$156.60 - $234.80/hr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 12 days ago


Vertex Pharmaceuticals rating

6.5

Company rating: 6.5 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

78th of 86 rated pharmaceutical


Job description

Job Summary

The Associate Director (AD) Quality Assurance (QA) is a senior technical resource responsible for overseeing quality assurance and compliance across all Quality Control and analytical development activities within Vertex’s Cell & Gene programs. The role drives QA oversight from analytical method validation to analytical transfer, stability testing, and regulatory submissions, ensuring adherence to FDA, EMA, and internal SOPs.

Key Responsibilities
  • Act as the QA Subject Matter Expert for QC, leading QA review and approval of analytical development, qualification, and validation activities.
  • Ensure stability programs are performed according to protocols and regulatory requirements.
  • Review regulatory submission sections and assist in responses to regulatory questions.
  • Conduct root cause analysis (RCA) and manage corrective & preventive actions (CAPA) for OOS/OOT results.
  • Lead QA review of deviation investigations, OOS, OOT, and change control documentation.
  • Provide QA operational oversight for internal QC laboratories and external contract testing laboratories.
  • Draft and enforce Quality Agreements with contract test labs and Vertex.
  • Leverage digital quality systems (MES, LIMS, eQMS), data analytics, and AI-enabled solutions to improve quality oversight and operational efficiency.
  • Serve as SME during audits and inspections, support QA risk management, and lead continuous improvement initiatives.
  • Support development of Vertex quality systems and processes, drafting/revising SOPs, policies, and work instructions.
  • Establish quality metrics for contract organizations to support excellence in quality systems.
Qualifications
  • Master’s degree in a scientific or allied health field (or equivalent) – Ph.D. preferred.
  • 8+ years of regulated pharmaceutical experience, or equivalent mix of education and experience.
  • In-depth knowledge of GxP QA and QC activities in cell therapies and GMP regulations.
  • Experience with MES, LIMS, eQMS, data visualization, and advanced analytics.
  • Experience running internal analytical labs and working with external test labs.
  • Proficiency in analytical method development.
  • Strong understanding of Root Cause Analysis, data analytics, and operational excellence frameworks (Lean, DMAIC, Six Sigma).
  • Excellent communication, influencing, and problem‑solving skills.
Other Requirements
  • Up to 15% travel.
  • On‑site designated flex scheduling – five days per week on site with ad‑hoc flexibility.
Pay Range

$156,600 – $234,800. Eligible for annual bonus, equity awards, and potential overtime pay in accordance with federal and state laws.

Benefits
  • Medical, dental, and vision coverage.
  • Generous paid time off, including annual company shutdowns.
  • Educational assistance and student loan repayment programs.
  • Commuting subsidy and charitable donation matching.
  • 401(k) plan with company match.
Equal Employment Opportunity Statement

Vertex is a global biotechnology company that is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants. Vertex will make reasonable accommodations for qualified individuals with disabilities in accordance with applicable law.

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