Top 57 Biotechnology quality assurance Jobs in Boston, Ma

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
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
GMP Operational Quality Senior Specialist (Stability)
Vertex Pharmaceuticals —Boston, MA
- $94,200 - $141,200 a year
- Full-time
- Hybrid work
- 3 years
- Bachelor's degree
- Organizational skills
- Loan repayment program
- Dental insurance
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
Program Quality Associate Director, Assurance
Vertex Pharmaceuticals —Boston, MA
- $155,400 - $233,000 a year
- Full-time
- Hybrid work
- 5 years
- Master's degree
- Analysis skills
- Loan repayment program
- Dental insurance
3d
Scientist I, Analytical Development and Quality Control
Kailera Therapeutics, Inc. —Waltham, MA
- $106,000 - $130,000 a year
- Full-time
- Hybrid work
- Mid-level
- Master's degree
- 8 years
- Commuter assistance
- Paid holidays
Quick Apply
Associate Director, Quality Operations
Amylyx Pharmaceuticals —Cambridge, MA
- $172,000 - $194,000 a year
- 8 years
- Bachelor's degree
- Travel
Analytical Quality Assurance, Associate Director
Vertex Pharmaceuticals —Boston, MA
- $156,600 - $234,800 a year
- Full-time
- Master's degree
- 8 years
- Doctor of Philosophy
- Loan repayment program
- Dental insurance
Quality Control Analyst I - Microbiology
Catalent —Chelsea, MA
- $59,000 - $75,000 a year
- Email
- Bachelor's degree
- 1 year
- Entry level
- Paid holidays
- Health insurance
Senior Director, Quality Control
EPM Scientific —Boston, MA
- Contract
- Bachelor's degree
- Mentoring
- US work authorization
Quick Apply
5d
Senior Manager, RDQ Learning & Documentation Governance
Vertex Pharmaceuticals —Boston, MA
- $129,400 - $194,200 a year
- Full-time
- 5 years
- Senior level
- Communication skills
- Loan repayment program
- Dental insurance
6d
Sr. Manager, GMP Quality Assurance
Deciphera Pharmaceuticals —Waltham, MA
- $138,000 - $190,000 a year
- Full-time
- Remote
- 8 years
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
Quick Apply
VICE PRESIDENT, QUALITY MANAGEMENT SYSTEMS AND DIGITAL COMPLIANCE
Intellia Therapeutics —Cambridge, MA
- $319,064 - $389,968 a year
- Remote
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
- Free parking
- Commuter assistance
Quality Assurance Compliance Specialist I
Zoll Medical Corporation —Chelmsford, MA
- $60,000 - $70,000 a year
- Engineering
- Associate's degree
- Communication skills
12d
Associate Director, GMP Operational Quality
Vertex Pharmaceuticals —Boston, MA
- $156,600 - $234,800 a year
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- Mentoring
- Loan repayment program
- Dental insurance
Associate Director, GMP Quality Assurance Operations
Kiniksa Pharmaceuticals —Lexington, MA
- $160,000 - $200,000 a year
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Office
Quick Apply
Director, Analytical Product Quality
Vertex Pharmaceuticals —Boston, MA
- $180,800 - $271,200 a year
- Full-time
- Doctor of Philosophy
- Travel
- Senior level
- Loan repayment program
- Dental insurance
Senior Scientist I, Quality Control
Candel Therapeutics —Needham, MA
- $155,000 - $160,000 a year
- Full-time
- Doctor of Philosophy
- US work authorization
- Computer skills
Associate Director, GMP Operational Quality (Biologics and Devices)
Vertex Pharmaceuticals —Boston, MA
- $94,600 - $141,800 a year
- Full-time
- Hybrid work
- 8 years
- Bachelor's degree
- Mentoring
- Loan repayment program
- Dental insurance

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QA Manager- Finished Goods Commercial

Vertex Pharmaceuticals -
Boston, MA

Apply Now

Job Details

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

Benefits

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

Qualifications

Data visualization software proficiency
GMP
Project management experience in manufacturing
Bachelor's degree
Pharmaceutical company experience
Managing projects
Regulatory compliance analysis
Data visualization projects
Technical Proficiency
Cross-functional communication
Data analysis software
Pharmaceutical manufacturing facility experience

Full Job Description

Job Description

General Summary:

The Quality Manager provides oversight of department activities, ensuring alignment with corporate goals and regulatory requirements. This includes managing multiple complex projects, troubleshooting issues, and fostering collaboration with business partners and stakeholders to ensure the continuation of supply in all markets. The Quality Manager will also be responsible for overseeing and managing the end-to-end product disposition process for Finished Goods. This role ensures timely and compliant product release by overseeing data readiness and collaborating with Contract Manufacturing Organizations (CMOs) and internal teams to implement continuous improvement measures. The position reports to the Associate Director and plays a critical role in driving quality initiatives and maintaining the integrity of deliverables

KEY RESPONSIBILITIES

Key Responsibilities of the position may include, but are not limited to the following:

Product Disposition Management

Oversee product disposition for Finished Goods, ensuring compliance with regulatory and quality standards.
Collaborate with Contract Manufacturing Organizations (CMOs) to resolve disposition-related issues and align on timelines and quality expectations.
Review of Executed Batch Records (EBRs) for commercial packaging operations and resolution of comments with CMOs
Review of impacting change controls against full lot genealogy to determine if material is compliant in relevant region(s), make disposition decision, and perform batch release
Evaluations of Investigations/ OOS/ Change Controls to support Disposition Decision
Assist with EAC and Material Review Board activities, when necessary
Manage data readiness for product disposition, including batch records, Certificates of Analysis (CoA), and supporting documentation.

Stakeholder Collaboration

Develop and manage relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and manager ongoing relationships. As CMO lead, be responsible for management of QA relationships with one or more CMOs.
Act as the primary QA contact for disposition-related queries and escalations.

Compliance and Continuous Improvement

Provide quality guidance for root-cause analysis, product impact assessments, and CAPA actions.
Support GMP/GDP management reviews, risk assessments, and mitigation strategies.
Identify and implement process improvements to enhance internal QA processes as well as Vendor performance.

Communication

Prepare and present (as needed) operational and quality reports, including disposition performance metrics, trends, risks, and mitigation plans.

Audit and Inspection Support

Serve as SME responder and provide support for audit/inspection preparation, execution, and post-inspection activities.

MINIMUM QUALIFICATIONS:

Bachelor’s degree in Life Sciences, Pharmacy, or a related health field.
4+ years of experience in pharmaceutical manufacturing (Packaging and Labelling Operations preferred), quality assurance, or Finished Goods product disposition.
Strong knowledge of global GMP requirements and oral drug product manufacturing practices.
Proficiency in data analysis and visualization tools.

PREFERRED QUALIFICATIONS:

Strong leadership skills with the ability to thrive in a high throughput environment
Attention to detail
Critical Thinking / Problem Solving
Ability to evaluate quality matters and make decisions utilizing risk-based approach
Project Management / Continuous Improvement

o Ability to lead and manage projects/teams within corporate objectives and project timelines

o Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks

o Demonstrated ability to work independently to provide QA support for large, multifaceted projects

Collaboration / Teamwork / Conflict Management

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

o Ability to understand and translate business needs

o Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff

o Represents Vertex Commercial Quality Assurance on cross functional working teams and is recognized for strong communication and influencing skills

Flexibility/Adaptability
Knowledge in the following areas:

o Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices

o GMP/GDP regulations and application to Manufacturing and Testing risk management principles

o Root Cause Analysis tools/methodology

Broad GxP Knowledge and understanding across lifecycle of the product
Sense of urgency - ability to act quickly/escalation process/transparency

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

biotechnology quality assurance jobs in boston, ma

QA Manager- Finished Goods Commercial

Senior Manager, Operational Area Quality (Combination Products)

Senior Manager, Clinical Study Quality Lead (Hybrid)

GMP Operational Quality Senior Specialist (Stability)

Quality Assurance Manager

Program Quality Associate Director, Assurance

Scientist I, Analytical Development and Quality Control

Associate Director, Quality Operations

Analytical Quality Assurance, Associate Director

Quality Control Analyst I - Microbiology

Senior Director, Quality Control

Senior Manager, RDQ Learning & Documentation Governance

Sr. Manager, GMP Quality Assurance

VICE PRESIDENT, QUALITY MANAGEMENT SYSTEMS AND DIGITAL COMPLIANCE

Quality Assurance Compliance Specialist I

Associate Director, GMP Operational Quality

Associate Director, GMP Quality Assurance Operations

Director, Analytical Product Quality

Senior Scientist I, Quality Control

Associate Director, GMP Operational Quality (Biologics and Devices)

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