Top 612 Quality assurance managers Jobs in Hudson, 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
Senior Associate, Plant Quality Assurance
Replimune —Framingham, MA
- $99,500 - $128,500 a year
- Full-time
- Bachelor of Science
- Mid-level
- 3 years
- Paid holidays
- Health insurance
Quick Apply
13d
Proj Mgr-Supplemental Work Engineering
Keolis Commuter Services —Somerville, MA
- $90,000 - $120,000 a year
- Hybrid work
- Background check
- Construction site
- Writing skills
- Disability insurance
- Health insurance
Quick Apply
Project Manager -Exhibits and Trade Show
Access TCA —Whitinsville, MA
- $60,000 - $80,000 a year
- Extended hours
- CAD
- 5 years
- Team management
Home Health RN Case Manager
West River Care —Newton, MA
- $50 an hour
- Full-time
- Vital signs
- RN License
- BLS Certification
Quick Apply
Director of Clinical Quality and Resident Care (RN license required)
Rogerson Communities —Boston, MA
- $135,000 - $150,000 a year
- Full-time
- Nursing
- 7 years
- RN License
Quick Apply
13d
Project Manager
StratComm, Inc —Framingham, MA
- $70,000 - $90,000 a year
- Full-time
- Hybrid work
- Background check
- Mid-level
- 3 years
- Health insurance
- Dental insurance
Quick Apply
2d
Construction Project Manager (5 Years Exp Req)
Puritan Restoration —Norwood, MA
- $95,000 - $125,000 a year
- Full-time
- Clean driving record
- Construction site
- Residential
- Fuel card
- Health insurance
Quick Apply
IT Solutions Engineer for MSP
Veritas IT Solutions —Needham Heights, MA
- $60,000 - $80,000 a year
- Full-time
- Customer service
- Windows
- Mentoring
- Health insurance
- Dental insurance
Quick Apply
Bearings Manufacturing Engineering Manager
Lutco, Inc. —Worcester, MA
- $140,000 - $160,000 a year
- Full-time
- Microsoft Access
- Ability to walk for extended periods
- 5 years
Quick Apply
12d
Procurement Manager (Sutton, MA)
Catelli Brothers Family of Foods —Sutton, MA
- $135,000 - $140,000 a year
- Full-time
- Background check
- 5 years
- Computer literacy
- Health insurance
- Dental insurance
Quick Apply
Mind & Memory Director
Benchmark Senior Living —North Chelmsford, MA
- $73,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- 3 years
- Disability insurance
- Health insurance
Quick Apply
Senior Director, Global Inspection Management
Ultragenyx Pharmaceutical —Bedford, MA
- $241,400 - $298,200 a year
- Hybrid work
- 11+ years
- Bachelor's degree
- Children
- Gym membership
5d
MRI Technologist, $15,000 Sign on Bonus
Boston Medical Center —Brighton, MA
- $47.45 - $70.51 an hour
- Full-time
- Anatomy knowledge
- Hospital
- Customer service
- Health insurance
- Dental insurance
MRI Technologist, $15,000 Sign on Bonus
Boston Medical Center —Brighton, MA
- $47.45 - $70.51 an hour
- Full-time
- Anatomy knowledge
- Hospital
- Customer service
- Health insurance
- Dental insurance
MRI Technologist, 15,000 Sign-On Bonus!
Boston Medical Center —Brighton, MA
- $47.45 - $70.51 an hour
- Weekends as needed
- Anatomy knowledge
- Hospital
- Customer service
- Health insurance
- Dental insurance
Product Metallurgist
Wyman-Gordon —Worcester, MA
- $75,000 - $85,000 a year
- Full-time
- Microsoft Excel
- Mentoring
- Experience equivalent to degree accepted
- Health savings account
- Relocation assistance
Quick Apply
Nurse Manager
TalentBurst, Inc. —Concord, MA
- $3,848 - $3,928 a week
- Weekends as needed
- Nursing
- RN License
- 5 years
- Health insurance
- Dental insurance
Quick Apply
5d
MRI Technologist, 15,000 Sign-On Bonus!
Boston Medical Center —Brighton, MA
- $47.45 - $70.51 an hour
- Weekends as needed
- Anatomy knowledge
- Hospital
- Customer service
- Health insurance
- Dental insurance
Quick Apply
Customer Quality Engineer
Materion Newton Inc. —Newton, MA
- $85,000 - $111,510 a year
- Full-time
- Engineering
- English
- Mid-level
Quick Apply

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Quality Assurance Manager

Ardelyx -
Waltham, MA

Apply Now

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.

Apply Now

Refine Your Search

quality assurance managers jobs in hudson, ma

Quality Assurance Manager

Senior Associate, Plant Quality Assurance

Proj Mgr-Supplemental Work Engineering

Project Manager -Exhibits and Trade Show

Home Health RN Case Manager

Director of Clinical Quality and Resident Care (RN license required)

Project Manager

Construction Project Manager (5 Years Exp Req)

IT Solutions Engineer for MSP

Bearings Manufacturing Engineering Manager

Procurement Manager (Sutton, MA)

Mind & Memory Director

Senior Director, Global Inspection Management

MRI Technologist, $15,000 Sign on Bonus

MRI Technologist, $15,000 Sign on Bonus

MRI Technologist, 15,000 Sign-On Bonus!

Product Metallurgist

Nurse Manager

MRI Technologist, 15,000 Sign-On Bonus!

Customer Quality Engineer

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