Top 189 Quality assurance manager Jobs in Somerville Ma

GMP Operational Quality Manager
Vertex Pharmaceuticals —Boston, MA
- $118,400 - $177,600 a year
- Full-time
- Hybrid work
- 5 years
- Analysis skills
- Bachelor's degree
- Loan repayment program
- Health insurance
Quality Manager -- Thermoplastic Piping and Valves
Asahi America Inc. —Lawrence, MA
- $83,100 - $116,500 a year
- Full-time
- 5 years
- Engineering
- Mentoring
- Continuing education credits
- AD&D insurance
Quick Apply
14d
RN Clinical Manager/QA Nurse - HYBRID Role!
MARY ANN MORSE HEALTHCARE CORP —Framingham, MA
- $80,000 - $95,000 a year
- Full-time
- Hybrid work
- Nursing
- RN License
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
5d
Quality Assurance Manager
Concord Foods LLC —Brockton, MA
- $115,000 - $140,000 a year
- Full-time
- Microsoft Word
- Background check
- Management
- Health insurance
- Dental insurance
Quick Apply
Lead Quality Engineer
GE Aerospace —Lynn, MA
- Full-time
- Pass drug screening
- Mid-level
- 3 years
- Paid parental leave
- Disability insurance
2d
Principal Configuration Analyst - PCA Lead
Raytheon —Andover, MA
- $86,800 - $165,200 a year
- Full-time
- 3 years
- Bachelor's degree
- Product management
- Paid holidays
- Disability insurance
3d
Lead Housekeeper - Quality Assurance and Inventory Control
Churchill Living —Boston, MA
- $20 - $22 an hour
- Part-time
- Background check
- Computer literacy
- Mid-level
Quick Apply
Staff Product Risk Manager
Draeger Medical Systems, Inc. —Andover, MA
- $122,000 - $146,600 a year
- Hybrid work
- 5 years
- Engineering
- System design
- Free parking
- Paid holidays
6d
Lead Quality Inspector
DAVRON LLC —Hudson, MA
- $80,000 - $120,000 a year
- Full-time
- Management
- 5 years
- In-person
- Health insurance
- Dental insurance
Quick Apply
3d
Manager - Quality Engineering
Microchip Technology —Beverly, MA
- $91,000 - $247,000 a year
- Full-time
- Microsoft Excel
- 5 years
- Analysis skills
- Employee stock purchase plan
- Health insurance
Quality Manager
Ametek —Bedford, MA
- $120,000 - $145,000 a year
- Full-time
- Microsoft Excel
- 5 years
- Bachelor of Science
2d
Quality Assurance Manager II
General Atomics —Acton, MA
- Extended hours
- Engineering
- Analysis skills
- Travel
3d
Lead Quality Engineer- Boston - RTH-70% hands-on and 30% leadership- Cloud and AI exp
Yoh, A Day & Zimmermann Company —Boston, MA
- $49.11 - $70.15 an hour
- Contract
- Hybrid work
- Computer science
- Computer Science
- Office
- Health savings account
- Disability insurance
Quick Apply
Senior Manager, GCP & GVP, QA
Agios Pharmaceuticals —Cambridge, MA
- $131,035 - $196,553 a year
- Remote
- Project management
- Travel
- Senior level
- Health insurance
Quality Assurance Manager
Plymouth Rock Assurance Corporation —Boston, MA
- $130,000 - $165,000 a year
- Computer Science
- DevOps
- Master's degree
Quick Apply
Senior Manager, Clinical Quality Assurance
Deciphera Pharmaceuticals —Waltham, MA
- $138,000 - $190,000 a year
- Full-time
- Remote
- Bachelor's degree
- Travel
- Conflict management
- Health insurance
- Dental insurance
Quick Apply
Manager, Quality Control
Nuvalent, Inc. —Cambridge, MA
- $125,000 - $145,000 a year
- Remote
- Bachelor's degree
- Organizational skills
- Experience equivalent to degree accepted
- Health insurance
- Dental insurance
Quick Apply
6d
Manager, Quality Systems
Genetix Biotherapeutics —Somerville, MA
- $117,000 - $166,000 a year
- Full-time
- Hybrid work
- 5 years
- Office
- Senior level
- Free parking
- Commuter assistance
QA Manager, Training (LMS)
Genetix Biotherapeutics —Somerville, MA
- $124,000 - $157,000 a year
- Full-time
- Hybrid work
- 5 years
- Office
- Bachelor's degree
- Free parking
- Commuter assistance
Manager, Quality Computerized System Validation (CSV)
Nuvalent, Inc. —Cambridge, MA
- $125,000 - $145,000 a year
- Remote
- Mid-level
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply

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quality assurance manager jobs near somerville ma

GMP Operational Quality Manager

Vertex Pharmaceuticals -
Boston, MA

Apply Now

Job Details

Full-time
$118,400 - $177,600 a year

Benefits

Loan repayment program
Health insurance
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching

Qualifications

Incident investigation techniques for hazard identification
Investigations regulatory compliance
Defect resolution root cause analysis
Document control within pharmaceutical industry
Production deviation management
Quality control preventive actions
Corrective and preventive actions (CAPA)
GMP
Internal investigations
Project management in manufacturing
Pharmaceutical company experience
Quality assurance within pharmaceutical industry
Mentoring
Data interpretation
Leading team collaboration initiatives
Managing projects
Operational excellence initiatives
Process improvement planning
Cross-functional team management
Teaching
Cross-functional communication
Managing quality assurance teams
Failure analysis
Pharmaceutical manufacturing facility experience
Staff development

Full Job Description

Job Description

The Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Quality Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements .

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to analytical testing at contracted suppliers .

Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed .

Assists Change Control owners with ensuring compliance to change procedure requirements , a ssesses and approves change controls .

Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.

Ensures appropriate CAPA actions are identified and addressed.

Approves investigations/CAPAs.

Identify , facilitate , and/or lead continuous improvement efforts .

Maintains Quality Metrics to support process improvement activities .

Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports .

Performs disposition activities in support of Commercial products .

Responsible for coordinating, facilitating and follow up on any QLT action items assigned.

Identify and communicate risks and assist with risk mitigation plans as necessary .

Supports internal audit or external audit programs .

Assists in preparation of audit responses .

Manages audit CAPAs & metrics .

Provides technical advice for partner and regulatory agency audits .

Minimum qualifications:

Knowledge and Skills:

In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing and analytical lab testing.

Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives .

E xperience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks .

Ability to independently lead cross-functional teams and represent the Quality unit .

A bility to mentor and guide staff, skilled at transferring technical knowledge and teaching quality management skills .

Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action .

Demonstrated ability to work independently to provide QA advice for large, multifaceted projects .

Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement and the analysis/synthesis of a variety of information; able to work outside of precedent and takes a new perspective on existing solutions .

Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA .

Strong experience with electronic document management systems (e.g., Veeva) .

Education and Experience:

Bachelor’s degree in a scientific or allied health field with 5 + years of relevant work experience, or the equivalent combination of education and experience.

Experience providing Quality support and oversight of GMP manufacturing operation including batch disposition.

Experience with drug substance, spray dried dispersion (SDD) and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting.

Knowledge of cGMP requirements governing oral drug products manufacturing practices .

Pay Range:

$118,400 - $177,600

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:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : 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-Hybrid

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 [email protected]

Apply Now

Refine Your Search

quality assurance manager jobs in somerville ma

GMP Operational Quality Manager

Quality Manager -- Thermoplastic Piping and Valves

RN Clinical Manager/QA Nurse - HYBRID Role!

Quality Assurance Manager

Lead Quality Engineer

Principal Configuration Analyst - PCA Lead

Lead Housekeeper - Quality Assurance and Inventory Control

Staff Product Risk Manager

Lead Quality Inspector

Manager - Quality Engineering

Quality Manager

Quality Assurance Manager II

Lead Quality Engineer- Boston - RTH-70% hands-on and 30% leadership- Cloud and AI exp

Senior Manager, GCP & GVP, QA

Quality Assurance Manager

Senior Manager, Clinical Quality Assurance

Manager, Quality Control

Manager, Quality Systems

QA Manager, Training (LMS)

Manager, Quality Computerized System Validation (CSV)

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