Top 92 Director of quality assurance Jobs in Brookline Ma

Sr. Director, Quality Assurance for Quality Control
Vaxcyte —Boston, MA
- $229,000 - $268,000 a year
- Remote
- 11+ years
- Bachelor's degree
- Senior level
Quality Director
University of Massachusetts Medical School —Westborough, MA
- $130,000 - $145,000 a year
- Full-time
- Hybrid work
- 3 years
- Bachelor's degree
- Senior level
Director of Food Safety and Quality
Welch's —Waltham, MA
- $185,000 - $195,000 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Office
- 8 years
- Paid parental leave
- Health savings account
Quick Apply
Quality Director, Single Use Division - Flexible Operations Sites
Thermo Fisher Scientific —Waltham, MA
- $160,000 - $218,250 a year
- Full-time
- Engineering
- 11+ years
- Office
- Commuter assistance
- Paid parental leave
Senior Quality Director
Nova Biomedical —Waltham, MA
- $220,000 - $300,000 a year
- Full-time
- Hybrid work
- Ability to lift 50 pounds
- In-person
- Senior level
- Paid holidays
- Health insurance
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Associate Director, Quality Assurance GCP
Cogent Biosciences —Waltham, MA
- $180,000 - $205,000 a year
- Office
- 8 years
- Bachelor's degree
- Free parking
- Paid parental leave
Quick Apply
Director, Quality Systems
Replimune —Framingham, MA
- $191,500 - $247,500 a year
- Full-time
- Bachelor's degree
- Conflict management
- Experience equivalent to degree accepted
- Paid holidays
- Health insurance
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
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Senior Director, Quality Control
EPM Scientific —Boston, MA
- Contract
- Bachelor's degree
- Mentoring
- US work authorization
Quick Apply
Senior Director, Quality Management Systems & Compliance
Intellia —Cambridge, MA
- $251,771 - $307,721 a year
- Full-time
- Remote
- Bachelor of Science
- 11+ years
- Analysis skills
Associate Director, Quality Assurance - CMC
Seaport Therapeutics —Boston, MA
- $180,000 - $195,000 a year
- Management
- 8 years
- Bachelor's degree
1d
Director of Food Safety, Quality Assurance & Regulatory Compliance
Compass Group —Boston, MA
- $125,000 - $130,000 a year
- Full-time
- ServSafe
- 5 years
- Bachelor's degree
Quick Apply
Senior Director, Quality
Repligen Corporation —Waltham, MA
- $191,250 - $260,000 a year
- Full-time
- Engineering
- 11+ years
- Product management
- Dental insurance
- Flexible spending account
Head of Quality Compliance
Sanofi —Framingham, MA
- $161,250.00 - $232,916.66 a year
- Master's degree
- 8 years
- Bachelor's degree
- Parental leave
Vice President, Head of Quality Assurance
Treeline Biosciences —Watertown, MA
- $285,000 - $350,000 a year
- 5 years
- Bachelor of Science
- Office
Quick Apply
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
- Health insurance
Head of Quality, Ambulatory Monitoring & Diagnostics
Philips —Cambridge, MA
- $205,000 - $349,440 a year
- Full-time
- Office
- Master's degree
- US work authorization
- Health savings account
- Employee stock purchase plan
5d
Director, R&D Quality Assurance Pharmacovigilance
Replimune —Framingham, MA
- $209,000 - $255,000 a year
- Full-time
- Remote
- Bachelor of Science
- Writing skills
- 3 years
- Paid holidays
- Health insurance
Quick Apply
9d
Assoc. Director, Quality - Commercial
Kiniksa Pharmaceuticals —Lexington, MA
- $186,000 - $200,000 a year
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Office
Quick Apply
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

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Sr. Director, Quality Assurance for Quality Control

Vaxcyte -
Boston, MA

Apply Now

Job Details

$229,000 - $268,000 a year

Qualifications

Drug regulation
GMP
Global team management
Team development
ICH guidelines
Quality risk management
Pharmaceutical analysis
Quality assurance experience within pharmaceutical industry
Collaboration with manufacturing teams
Managing projects
Verification of laboratory test methods
Quality control experience within pharmaceutical industry
Managing product quality assurance teams
Test validation method
Cross-functional team management
Cross-functional communication

Full Job Description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines. Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a Senior Director. This role carries dual accountability: providing direct QA support to the analytical operations based in Switzerland, while also managing the San Carlos-based QA team responsible for oversight of smaller-scale analytical activities. The Senior Director will be expected to operate effectively across both sites, navigating the distinct regulatory environments and operational cadences of each. The primary responsibility will be the QA oversight of QC activities associated with Vaxcyte's PCV Polysaccharides and Drug Substances. The Senior Director will work closely with internal teams (Process Development, MSAT, Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain the compliance of the analytical program.

Essential Functions:

Lead quality oversight activities related to method validation, release and in-process testing for Drug Substance and Polysaccharide
Serve as the primary liaison within Vaxcyte QA and with outside collaborators, building partnerships that support analytical needs for relevant programs.
Represent QA at internal and external cross functional team meetings.
Lead review and approval of internal and external GMP documentation for compliance, including specifications, Certificates of Analysis, validation reports, deviations, change controls, risk assessments, and CAPAs as they relate to polysaccharides and drug substance; apply technical and compliance expertise to critically evaluate reference standards, test methods, protocols, and raw data packages from CMOs and contract testing laboratories.
Partner with QC, vendor management, and contract labs to set key performance indicators for monitoring vendor effectiveness.
Drive resolution of quality performance issues with contract manufacturers and testing organizations
Review Quality Agreements and regulatory documentation as required.
Lead quality investigations of testing deviations and OOS.
Contribute to regulatory filings, respond to questions from health authorities, and ensure quality of documentation used in support of regulatory submissions.
Take part in audit preparations and help ensure ongoing readiness.
Develop, review, and update GMP-related internal policies and procedures as necessary.
Champion a culture of quality excellence and continuous improvement by proactively identifying systemic gaps, driving implementation of sustainable solutions, and establishing performance standards that elevate GMP compliance across internal teams and external partners.

Requirements:

Bachelor's degree in Biochemistry, Chemistry, or a related field with 15+ years of relevant industry experience. Other combinations of education and/or experience may be considered.

Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with proven expertise in applying these regulations to develop practical solutions and phase-appropriate analytical strategies.
Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment.
Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.
Excellent written and verbal communication skills, including the ability to work effectively in cross-functional teams.
Previous experience in validation and transfer of analytical assays.
Demonstrated ability to build and develop high-performing QA teams and influencing cross-functional and executive stakeholders in a fast-paced commercial-stage biotech company.
Knowledge and experience in Risk Management principles.
Knowledge in both clinical and commercial product desired.
Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
Ability to work globally with CMOs in different countries and continents.
Experience managing geographically distributed QA teams across multiple sites or countries, with the ability to build cohesive quality culture and consistent GMP standards across locations.
Experience in BLA submission and commercial launch is highly desirable

Reports to: Executive Director, Quality Assurance

Location: Raleigh, NC

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $229,000 – $268,000 (North Carolina)

Equal Opportunity

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Recruitment Fraud Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.

Apply Now

Refine Your Search

director of quality assurance jobs in brookline ma

Sr. Director, Quality Assurance for Quality Control

Quality Director

Director of Food Safety and Quality

Quality Director, Single Use Division - Flexible Operations Sites

Senior Quality Director

Associate Director, Quality Assurance GCP

Director, Quality Systems

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

Senior Director, Quality Control

Senior Director, Quality Management Systems & Compliance

Associate Director, Quality Assurance - CMC

Director of Food Safety, Quality Assurance & Regulatory Compliance

Senior Director, Quality

Head of Quality Compliance

Vice President, Head of Quality Assurance

Analytical Quality Assurance, Associate Director

Head of Quality, Ambulatory Monitoring & Diagnostics

Director, R&D Quality Assurance Pharmacovigilance

Assoc. Director, Quality - Commercial

Associate Director, GMP Quality Assurance Operations

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