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Quality Assurance Risk Manager Jobs in Lowell, MA

Ardelyx

Quality Assurance Manager

Waltham, MA · Hybrid

The position requires strong technical expertise in GMP quality systems, CMC QA, and quality risk management, along with the ability to independently manage complex quality activities and partner ...

Ardelyx

Quality Assurance Manager

Waltham, MA · Hybrid

$139K - $169K/yr

The position requires strong technical expertise in GMP quality systems, CMC QA, and quality risk management, along with the ability to independently manage complex quality activities and partner ...

Ardelyx

Quality Assurance Manager

Waltham, MA · On-site

$139K - $169K/yr

The position requires strong technical expertise in GMP quality systems, CMC QA, and quality risk management, along with the ability to independently manage complex quality activities and partner ...

Ardelyx

Quality Assurance Manager

Waltham, MA · Hybrid

$139K - $169K/yr

The position requires strong technical expertise in GMP quality systems, CMC QA, and quality risk management, along with the ability to independently manage complex quality activities and partner ...

Sallie_mae

Director, Quality Assurance

Newton, MA

What You'll Contribute The Director of Vendor Quality Assurance will be responsible for leading end-to-end governance, risk management, and performance oversight of third-party vendor relationships.

Agenus, Inc.

Director, Quality Assurance

Lexington, MA · On-site

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

New

Stellar IT Solutions

QA Tester

Quincy, MA · On-site

Lead test planning, test case design, execution, risk assessment, defect tracking, and resolution ... Collaborate closely with business analysts, developers, project managers, and business stakeholders ...

Stellar IT Solutions LLC

QA Tester

Quincy, MA

$60/hr

Lead test planning, test case design, execution, risk assessment, defect tracking, and resolution ... Collaborate closely with business analysts, developers, project managers, and business stakeholders ...

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Quality Assurance Risk Manager information

See Lowell, MA salary details

$37.7K

$117.1K

$177.5K

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

As of Aug 3, 2026, the average yearly pay for quality assurance risk manager in Lowell, MA is $117,101.00, according to ZipRecruiter salary data. Most workers in this role earn between $82,300.00 and $143,300.00 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 cities near Lowell, MA are hiring for Quality Assurance Risk Manager jobs? Cities near Lowell, MA with the most Quality Assurance Risk Manager job openings:
Quality Assurance Risk Manager jobs near you

Analytical Quality Assurance, Associate Director

Vrtx

Boston, MA • On-site

$156K - $234K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 17 days ago

Job description

Job Description

General Summary:

The Associate Director (AD) Quality Assurance (QA for QC) is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for the quality oversight of Quality Control and analytical development activities of Cell & Gene programs. Activities in scope of this role include release analytical testing, stability testing, and QA support for deviations and out of specification investigations. The role will have QA oversight of technical analytical method validations and analytical transfer activities internally /CDMOs through the program life cycle management.

Key Duties and Responsibilities:

Analytical Lifecycle Management:

  • Serve as a Quality Assurance Subject Matter Expert for in QC domain and drive culture of quality to assure compliance with FDA, EMA, and internal SOPs.
  • Lead QA review and approval of analytical development, qualification and validation as well as analytical technical transfer activities
  • Ensure stability program is conducted in compliance with established protocols and applicable regulations.
  • Review relevant sections of regulatory submissions; Assist in responses to regulatory questions.

Compliance & Investigations

  • Ensuring proper root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) for Out of Specification (OOS) and Out of Trend (OOT) results
  • Perform/lead QA review and approval of QC associated documentation including deviation investigations, OOS, OOT and change control.

CTO & CMO Management:

  • Execute QA operational oversight for internal QC laboratories and external contract testing laboratories.
  • Drafts and enforces Quality Agreements between Contract Test Labs and Vertex.

Digital & Artificial Intelligence

  • Demonstrated understanding of digital quality systems, data management, automation, and emerging AI technologies within regulated GxP environments.
  • Experience leveraging data analytics, digital tools, and AI-enabled solutions to improve quality oversight, operational efficiency, and decision-making.
  • Responsible for using platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics to perform Quality oversight.

Quality Management Systems (QMS): Utilizing eQMS platforms for change controls and deviation tracking

  • Acting as the subject matter expert (SME) during audits and inspections regulatory agencies
  • Support/lead QA risk management activities, including mitigation plans and associated execution.
  • Support development of Vertex quality systems and processes, draft/revise SOPs, policies and work instructions.
  • Identify, facilitate, and/or lead continuous improvement efforts
  • Ensure development of quality metrics at the contract organizations that support excellence in quality systems

Knowledge and Skills:

  • In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies
  • Broad understanding of regulatory environment including quality systems, compliance and GMP regulations.
  • Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
  • Prior experience working /running internal analytical lab and working with external Test labs.
  • Experience in analytical method development
  • Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
  • Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
  • Critical Thinking and Problem Solving skills

Education and Experience:

  • Master's degree in a scientific or allied health field (or equivalent degree)
  • Ph.D. preferred
  • 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.

Other Requirements:

  • Up to 15% travel

Pay Range:

$156,600 - $234,800

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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