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Quality Assurance Risk Manager Jobs in Worcester, 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 · On-site

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.

SofTec Solutions

QA Analyst

Waltham, MA · On-site

The Software Quality Assurance (SQA) Engineer for FS Risk & Compliance has primary responsibility ... Managing standard project methodology and templates customized for each project's unique needs ...

Repligen

Quality Assurance Specialist I

Marlborough, MA · On-site

$30.24 - $40.92/hr

The Quality Assurance Specialist I supports the Tangenx and Dulocore product lines as part of the ... Apply Quality Risk Management principles in daily decision-making * Identify, assess, and escalate ...

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Quality Assurance Risk Manager information

See Worcester, MA salary details

$37.9K

$117.8K

$178.6K

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

As of Aug 6, 2026, the average yearly pay for quality assurance risk manager in Worcester, MA is $117,817.00, according to ZipRecruiter salary data. Most workers in this role earn between $82,800.00 and $144,200.00 per year, depending on experience, location, and employer.

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 or service quality. It includes implementing standards, procedures, and audits to ensure compliance and reduce the likelihood of defects or failures, thereby maintaining organizational quality and safety. Familiarity with risk assessment tools and quality management systems like ISO 9001 is essential for effective risk mitigation.

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 Worcester, MA are hiring for Quality Assurance Risk Manager jobs? Cities near Worcester, MA with the most Quality Assurance Risk Manager job openings:
Quality Assurance Risk Manager jobs near you

Quality Assurance Manager

Ardelyx

Waltham, MA • Hybrid

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 10 days ago

Job description

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.
 
Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.
 
We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.
 
Position Summary:
 
The Quality Assurance Manager will serve within Quality Assurance, providing oversight and hands-on support for achieving QA milestones, in a fast-paced pharmaceutical environment. This role will be deeply engaged in day-to-day quality operations, including batch record review, product disposition, investigations, quality agreements, and quality systems support.
 
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 cross-functionally across the organization. In addition to core operational responsibilities, this individual will serve as the primary QA representative supporting operations on the East Coast and provide occasional back-up support to department management to help ensure continuity when coverage is needed.
 
Responsibilities:
  • Serve as the primary QA representative supporting day-to-day activities for teams and operations located on the east coast
  • Provide QA oversight for CMC activities supporting development, clinical, and commercial products
  • Evaluate completed manufacturing documentation (batch records, COAs, packaging records, and related GMP documentation) from CMOs to ensure accuracy, completeness, and compliance
  • Review and approve batch record and product disposition activities in support of clinical trials, process validation, registration activities, and commercial product distribution
  • Review and approve development, qualification, and validation protocols and reports
  • Collaborate cross-functionally with CMC, Regulatory Affairs, Supply Chain, and external partners to support quality and compliance activities throughout the product lifecycle
  • Provide QA oversight of CMO and suppliers’ activities to ensure required quality standards and regulatory expectations are maintained
  • Generate Annual Product Quality Report, quality metrics, management review inputs, and KPI reporting
  • Ensure Quality Agreements clearly define GMP responsibilities, and quality oversight expectations and responsibilities between parties
  • Assist with inspection readiness activities and support internal and external GMP audits
  • Participate in quality systems activities, including deviations, investigations, OOS events, change controls, and related GMP processes
  • Identify and support continuous improvement opportunities within QA processes and systems
  • Ensure compliance with cGMP, ICH, FDA, EU, and other applicable regulatory requirements
 
This is a hybrid role (2-3 days in office) at our Waltham, MA headquarters.
 
Qualifications:
  • Bachelor’s degree in science or related field with 10+ years of progressive GxP Quality Assurance experience within biotechnology or equivalent experience.
  • Experience in relevant CMC area (DS, DP), with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes
  • Experience in a manufacturing setting as a Quality person in the plant (QA PIP)
  • Extensive knowledge of GMP regulations and guidance (such as FDA, EU, and ICH)
  • Experience with Quality Assurance systems and processes
  • Excellent investigational and QA problem-solving skills
  • Strong technical writing skills
  • Advanced software skills including SharePoint, and Veeva
The anticipated annualized base pay range for this full-time position is $139,000 - $169,000 Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
 
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
 
Ardelyx is an equal opportunity employer.
 
We do not accept unsolicited resumes from search firms, or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Company's career site without a valid, signed search agreement signed by Company's authorized representative will be deemed the property of the company, and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.