Top 151 Quality assurance manager Jobs in Chelmsford, Ma

Quality Assurance Manager
Ardelyx —Waltham, MA
- $139,000 - $169,000 a year
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- SharePoint
- Paid parental leave
- Paid holidays
Quality Manager
AMETEK, Inc. —Chelmsford, MA
- $90,000 - $125,000 a year
- Microsoft Excel
- Management
- 5 years
- Opportunities for advancement
5d
Quality Manager for CNC Machine Shop (Watertown, MA)
Confidential-Manufacturing —Watertown, MA
- $90,000 - $130,000 a year
- Full-time
- Management
- Engineering
- Windows
- Profit sharing
- Health insurance
Quick Apply
Quality Assurance Manager
Confidential —Leominster, MA
- $90,000 - $95,000 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Quick Apply
Quality Assurance Manager
ANCORE —Salem, MA
- $70,000 - $80,000 a year
- Full-time
- Engineering
- Mid-level
- Continuous improvement
- Health insurance
- Dental insurance
Quick Apply
Training, Quality and Operations Manager
Walker, Inc. —Needham, MA
- $72,000 - $90,000 a year
- Full-time
- Bilingual
- Background check
- LMFT
- Health savings account
- Health insurance
Quick Apply
Quality Manager
TTM Technologies —Salem, NH
- Full-time
- Microsoft Excel
- 6 years
- Engineering
- Health savings account
- Paid holidays
8d
Quality Assurance Manager
Masis Professional Group —Lynn, MA
- $130,000 a year
- Spanish
- English
- Bachelor's degree
Quick Apply
Principal Functional Lead, Quality Programs
Getinge —Merrimack, NH
- $115,000 - $140,000 a year
- Full-time
- 7 years
- Microsoft Excel
- Engineering
- Commuter assistance
- Disability insurance
Manager-Quality Engineering
Microchip Technology —Lawrence, MA
- $91,000 - $247,000 a year
- Full-time
- 3 years
- Supervising experience
- Travel
- Employee stock purchase plan
- Health insurance
QUALITY MANAGER
HW Staffing Solutions —Lawrence, MA
- $110,000 - $120,000 a year
- Full-time
- Background check
- 5 years
- Engineering
- Health insurance
- Dental insurance
Quick Apply
QA Manager- Finished Goods Commercial
Vertex Pharmaceuticals —Boston, MA
- $118,400 - $177,600 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Product management
- Conflict management
- Loan repayment program
- Dental insurance
Senior Manager, Operational Area Quality (Combination Products)
Vertex Pharmaceuticals —Boston, MA
- $133,800 - $200,600 a year
- Full-time
- Hybrid work
- Engineering
- Senior level
- Leadership
- Loan repayment program
- Dental insurance
Manager Quality Control
TransMedics, Inc. —Andover, MA
- $118,600 - $148,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Engineering
- Employee stock purchase plan
- Disability insurance
Quick Apply
Senior Manager, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals —Boston, MA
- $137,800 - $206,800 a year
- Full-time
- Hybrid work
- 6 years
- Project management
- Bachelor's degree
- Loan repayment program
- Dental insurance
Quality Assurance and Regulatory Affairs Manager
Taza Chocolate —Somerville, MA
- $80,000 - $95,000 a year
- Full-time
- Microsoft Excel
- 3 years
- Senior level
- Disability insurance
- Health insurance
2d
Quality Manager
Goodwin Recruiting —Watertown, MA
- $95,000 - $120,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Bachelor's degree
Quick Apply
Quality Control Manager
Micro Tech Staffing Group —Hudson, MA
- $85,000 - $110,000 a year
- Full-time
- 5 years
- Analysis skills
- Supervising experience
Quick Apply
1d
Manager, Vendor Quality Management (Contract) 29131
Vertex Pharmaceuticals —Boston, MA
- $65 - $70 an hour
- Full-time
- 6 years
- Writing skills
- Math
Senior Manager, Clinical Quality Assurance
Kura Oncology —Boston, MA
- $160,000 - $187,000 a year
- Remote
- 6 years
- Bachelor of Science
- Adults
- Paid parental leave
- Employee stock purchase plan

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quality assurance manager jobs near chelmsford, ma

Quality Assurance Manager

Ardelyx -
Waltham, MA

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Job Details

Full-time
$139,000 - $169,000 a year

Benefits

Paid parental leave
Paid holidays
Health insurance
Dental insurance
Parental leave
Vision insurance
401(k) matching
Life insurance

Qualifications

Biotechnology
Content creation for technical audiences
Drug regulation
Technical writing experience within manufacturing
GMP
ICH guidelines
Quality risk management
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
SharePoint
Quality control problem-solving
Regulatory/legal compliance standards in production
Chemistry, manufacturing & controls
Biomedical regulatory compliance
Cross-functional communication
FDA regulations
Pharmaceutical manufacturing facility experience

Full 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.

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Refine Your Search

quality assurance manager jobs in chelmsford, ma

Quality Assurance Manager

Quality Manager

Quality Manager for CNC Machine Shop (Watertown, MA)

Quality Assurance Manager

Quality Assurance Manager

Training, Quality and Operations Manager

Quality Manager

Quality Assurance Manager

Principal Functional Lead, Quality Programs

Manager-Quality Engineering

QUALITY MANAGER

QA Manager- Finished Goods Commercial

Senior Manager, Operational Area Quality (Combination Products)

Manager Quality Control

Senior Manager, Clinical Study Quality Lead (Hybrid)

Quality Assurance and Regulatory Affairs Manager

Quality Manager

Quality Control Manager

Manager, Vendor Quality Management (Contract) 29131

Senior Manager, Clinical Quality Assurance

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