Top 112 Director of quality Jobs in Lexington Ma

Director of Quality Assurance & Control
Eckert & Ziegler Radiopharma Inc —Wilmington, MA
- $170,000 - $200,000 a year
- Full-time
- Bachelor's degree
- In-person
- Senior level
- Paid holidays
- Disability insurance
Quick Apply
Sr. Director of Quality
Teledyne Technologies Inc. —Billerica, MA
- $188,000 - $250,700 a year
- Full-time
- Product management
- Mentoring
- Organizational skills
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
Director of Quality & Regulatory
STgenetics —Lexington, MA
- Urgently hiring
- Engineering
- Office
- Master's degree
Quick Apply
5d
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
9d
Director, Clinical Quality Assurance
BioNTech AG —Cambridge, MA
- $168,100 - $268,700 a year
- Full-time
- Background check
- Microsoft Office
- Senior level
1d
Associate Director, Global Inspection Management
Ultragenyx Pharmaceutical —Bedford, MA
- $179,600 - $221,900 a year
- Hybrid work
- 11+ years
- Bachelor's degree
- Children
- Gym membership
13h
Quality Director (24568)
Ardent Staffing Solutions —Westborough, MA
- $130,000 - $145,000 a year
- Full-time
- Background check
- Engineering
- Pass drug screening
- Disability insurance
- Health insurance
Quick Apply
Sr. Director, Quality Assurance for Quality Control
Vaxcyte —Boston, MA
- $229,000 - $268,000 a year
- Remote
- 11+ years
- Bachelor's degree
- Senior level
1d
SENIOR DIRECTOR, QUALITY MANAGEMENT SYSTEMS & COMPLIANCE
Intellia Therapeutics —Cambridge, MA
- $251,771 - $307,721 a year
- Remote
- Bachelor of Science
- 11+ years
- Analysis skills
- Free parking
- Commuter assistance
GelSight: Director of Compliance and Quality
Anzu Partners —Waltham, MA
- Full-time
- Bachelor of Science
- Writing skills
- Engineering
Quick Apply
14d
Senior Director, Head of Clinical Program Quality & Excellence (TAU)
Takeda Pharmaceutical —Cambridge, MA
- $212,000 - $333,190 a year
- Full-time
- 11+ years
- Office
- Master's degree
- Paid holidays
- Disability insurance
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
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
Assoc. Director, Quality - Commercial
Kiniksa Pharmaceuticals —Lexington, MA
- $186,000 - $200,000 a year
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Office
Quick Apply
Senior Director, GMP Quality Assurance
Karyopharm Therapeutics Inc. —Newton, MA
- $275,000 - $300,000 a year
- Full-time
- Bachelor of Science
- Adults
- Bachelor's degree
- Health insurance
- Dental insurance
Sr. Director, Quality Compliance
Kiniksa Pharmaceuticals —Lexington, MA
- $250,000 - $273,000 a year
- Hybrid work
- 11+ years
- Office
- Doctor of Philosophy
Quick Apply
Director, Quality Systems & Compliance
ElevateBio —Waltham, MA
- $190,000 - $260,000 a year
- 11+ years
- Senior level
- Leadership
Quick Apply
Director, Quality Assurance
Textron Systems —Wilmington, MA
- $165,700 - $254,900 a year
- Full-time
- 5 years
- Word processing
- Analysis skills
- Health savings account
- Disability insurance
Director of Product Quality
Axcelis Technologies Inc. —Beverly, MA
- $168,283.60 - $252,425.40 a year
- Full-time
- Engineering
- Master's degree
- Travel

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director of quality jobs near lexington ma

Director of Quality Assurance & Control

Eckert & Ziegler Radiopharma Inc -
Wilmington, MA

Quick Apply

Job Details

Full-time
$170,000 - $200,000 a year

Benefits

Paid holidays
Disability insurance
Health insurance
Dental insurance
Paid time off
Employee assistance program
Vision insurance
401(k) matching

Qualifications

GMP
Manufacturing facility experience
Production validation processes
Bachelor's degree
Pharmaceutical company experience
Cleanroom experience
Quality control experience within pharmaceutical industry
FDA regulations

Full Job Description

*This is an on-site role based in Wilmington, MA. We are seeking candidates who are already located within commuting distance; relocation support is not provided*

Director of Quality Assurance & Control

Lead Quality at the Forefront of Nuclear Medicine

Eckert & Ziegler Radiopharma, Inc. (EZRI) is expanding its U.S. radiopharmaceutical manufacturing and CMO operations in Wilmington, MA — including the build-out and qualification of a new Lu-177 production capability that will directly support advancements in targeted cancer therapies.

We are seeking a highly capable, hands-on Director of Quality to lead QA, QC, validation oversight, and quality systems within a regulated cGMP environment.

This is not a maintenance role. It is an opportunity to shape and strengthen Quality during a critical phase of growth in one of the most dynamic sectors of modern medicine.

The Opportunity

The Director of Quality Assurance & Control will report directly to the General Manager and serve as a key member of the site leadership team. This role partners closely with the Director of Site & CMO Operations, Radiation Safety Officer, QC Manager, and cross-functional leaders to ensure compliant, coordinated execution of site priorities.

This is a highly hands-on leadership position. A visible, consistent presence on the manufacturing floor, in cleanrooms, and within daily operations is expected. The Director of Quality will actively engage with production, QC, and operations teams to ensure real-time quality oversight and decision-making — not operate solely from behind a desk.

A major near-term priority is supporting the Lu-177 facility expansion from a Quality standpoint, including equipment receipt, IQ/OQ/PQ oversight, cleanroom and facility qualification, and process validation.

This role is ideal for a leader who thrives in growth environments and wants to build something meaningful — not simply inherit a static system.

Key Responsibilities

Quality Leadership & Operational Engagement

Lead and manage site QA and QC functions
Maintain and strengthen the site Quality Management System (QMS)
Maintain strong, visible presence within manufacturing and laboratory operations
Provide real-time quality oversight and decision-making support on the production floor
Ensure compliance with FDA cGMP regulations (21 CFR Parts 210/211) and applicable regulatory standards
Oversee deviation investigations, CAPA, change control, and risk management processes
Ensure inspection readiness and lead regulatory and customer audits
Partner with site leadership to align quality strategy with operational execution

Equipment & Facility Qualification

Provide Quality oversight and approval of equipment qualification activities (IQ/OQ/PQ)
Support qualification of Lu-177 expansion areas, cleanrooms, utilities, and critical systems
Review and approve qualification protocols and reports
Ensure validation documentation meets regulatory expectations
Partner cross-functionally during equipment receipt, commissioning, and qualification to ensure compliant execution

Process Validation & Sterile Manufacturing

Oversight of process validation and continued process verification
Ensure method validation and QC laboratory readiness
Oversee batch record review and batch disposition release processes
Provide Quality oversight for isotope manufacturing and CMO operations
Ensure compliance within sterile, cleanroom-based manufacturing environments
Monitor aseptic practices and environmental controls to ensure sustained compliance

Qualifications

Bachelor’s degree in a scientific discipline; advanced degree preferred
10+ years of experience in pharmaceutical or biopharmaceutical manufacturing.
Demonstrated QA/QC leadership experience in a cGMP-regulated environment
Direct experience supporting equipment qualification and process validation programs
Strong experience in sterile manufacturing and cleanroom operations
Strong working knowledge of FDA cGMP regulations and inspection readiness practices
Experience supporting facility expansion or manufacturing build-outs strongly preferred
Radiopharmaceutical experience preferred

Benefits

EZRI offers a competitive benefits package designed to support our employees’ health, well-being, and professional growth, including:

100% employer-paid medical insurance for individual coverage
Subsidized medical plans for dependents and families
Dental and vision insurance
401(k) with generous company match
15 days of paid time off (PTO) plus company holidays
Life and disability insurance
Employee assistance program (EAP)
Opportunities for training and career development

Work Structure

On-site in Wilmington, MA
Hands-on, floor-engaged leadership role
Reports directly to the General Manager
Serves as a core member of the site leadership team

Why Join EZRI?

Lead Quality during a transformative Lu-177 manufacturing expansion
Contribute directly to advancements in nuclear medicine and targeted cancer therapy
Operate in a collaborative, mission-driven environment where leadership is accessible and engaged
Shape quality systems that support real growth — not just maintenance
Competitive compensation, annual bonus eligibility, and comprehensive benefits

If you are a cGMP Quality leader who values operational engagement, disciplined execution, and meaningful impact in healthcare, we welcome the opportunity to connect.

Quick Apply

Refine Your Search

director of quality jobs in lexington ma

Director of Quality Assurance & Control

Sr. Director of Quality

Director of Food Safety and Quality

Director of Quality & Regulatory

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

Director, Clinical Quality Assurance

Associate Director, Global Inspection Management

Quality Director (24568)

Sr. Director, Quality Assurance for Quality Control

SENIOR DIRECTOR, QUALITY MANAGEMENT SYSTEMS & COMPLIANCE

GelSight: Director of Compliance and Quality

Senior Director, Head of Clinical Program Quality & Excellence (TAU)

Quality Director, Single Use Division - Flexible Operations Sites

Associate Director, GMP Quality Assurance Operations

Assoc. Director, Quality - Commercial

Senior Director, GMP Quality Assurance

Sr. Director, Quality Compliance

Director, Quality Systems & Compliance

Director, Quality Assurance

Director of Product Quality

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