Top 7 Quality control associate Jobs in Framingham Ma

Associate Manager, Quality Assurance Operations
Genetix Biotherapeutics —Boston, MA
- $115,000 - $125,000 a year
- Full-time
- Hybrid work
- Office
- Senior level
- 4 years
Associate Director, Analytical Development & Quality Control
Entrada Therapeutics —Boston, MA
- $172,000 - $202,000 a year
- Remote
- 6 years
- Office
- Doctor of Philosophy
- Disability insurance
- Health insurance
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6d
Associate Director, Quality Control
Xenon Pharmaceuticals —Needham, MA
- $172,300 - $217,900 a year
- Full-time
- Hybrid work
- Office
- 8 years
- Bachelor's degree
- AD&D insurance
- Disability insurance
Quick Apply
10d
Inventory Control & Quality Assurance (ICQA) Associate
IntelliSource —Worcester, MA
- $22 - $26 an hour
- Overtime
- Ability to walk for extended periods
- Computer literacy
- Basic math
- Health insurance
- Dental insurance
Quick Apply
10d
Associate Director, Analytical Development and Quality Control
Kailera Therapeutics, Inc. —Waltham, MA
- $155,000 - $190,000 a year
- Full-time
- Hybrid work
- 5 years
- Bachelor's degree
- Travel
- Commuter assistance
- Paid holidays
Quick Apply
Associate Director, Quality Control Lab Automation
Moderna, Inc. —Norwood, MA
- $142,500 - $256,500 a year
- Full-time
- Computer Science
- 5 years
- Bachelor of Science
- Paid time off
- Adoption assistance

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Associate Manager, Quality Assurance Operations

Genetix Biotherapeutics
Boston, MA

Apply Now

Job Details

Full-time
$115,000 - $125,000 a year

Qualifications

Quality control corrective actions
Investigations regulatory compliance
Preventive action implementation
Production deviation management
Production risk assessment
Corrective and preventive actions (CAPA)
GMP
Incident Escalation
Internal investigations
Change management
ICH guidelines
Production validation processes
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Regulatory/legal compliance standards in production
Collaboration with manufacturing teams
Escalation handling
Cross-functional team management
Project stakeholder communication
Cross-functional communication
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

About Genetix Biotherapeutics

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Position Description:

The Associate Manager, Quality Assurance Operations will provide quality oversight of external manufacturing partners to ensure compliance with cGMP requirements, regulatory commitments, and Genetix quality standards. This role will serve as a key quality liaison across internal teams (Manufacturing, MS&T, Quality Control, and Patient Supply) and CMOs, supporting risk management, deviation and change control activities, quality system review, governance forums, and performance monitoring to drive consistent, compliant, and effective operations.

Job Duties and Responsibilities:

Provide on-call QA support for manufacturing operations, ensuring proactive identification, escalation, and mitigation of quality events and risks impacting ongoing manufacturing and product disposition
Maintain a consistent and effective external oversight model, including leading QA-to-QA forums and guiding quality discussions in joint governance meetings with CMOs.
Support regular internal Deviation/Lab Investigation Management meetings, ensuring compliance, quality, and timeliness.
Review and Approve internal and external CMO Deviations and Change Controls
Serve as QA point-of-contact for Product Complaints, ensuring appropriate investigation, documentation, and closure.
Perform Quality Impact Assessments for Change Controls, ensuring appropriate risk evaluation and mitigation.
Represent Quality Assurance Operations in Manufacturing Tier meetings, ensuring alignment on quality risks, priorities, and escalation pathways.
Represent Quality Assurance Operations in Change Control Review Board (CCRB) meetings.
Serve as QA reviewer and approver for: process validation protocols and reports, technical reports and supporting documentation, and internal and external validation deliverables
Monitor CMO quality performance metrics, identify trends, and drive continuous improvement initiatives.
Own and manage CMO Quality Agreements, including authoring, reviewing, negotiating, and maintaining compliance with current regulatory expectations.
Author and review Annual Product Quality Reviews (APQRs) to ensure comprehensive evaluation of product and process performance.
Identify trends, risks, and opportunities for improvement across the product lifecycle.

Essential/Required Qualifications

Education & Experience

Bachelor's degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
4-6 years of experience in Quality Assurance within GMP-regulated biopharmaceutical or cell/gene therapy manufacturing
Strong experience supporting CMO oversight and external manufacturing environments

Technical Skills

Deep knowledge of cGMP regulations (FDA, ICH guidelines)
Deviation, CAPA, and investigation processes
Change Control systems and validation lifecycle
Knowledge of lentiviral vector process preferred
Knowledge of process validation preferred
Strong understanding of cell/gene therapy manufacturing or biologics

Core Competencies

Demonstrated ability to lead cross-functional quality governance forums
Strong risk-based decision-making and escalation capabilities
Excellent communication, stakeholder management, and influential skills in internal and external settings
Ability to operate effectively in a fast-paced, matrixed CMO environment
High attention to detail with an inspection-ready mindset

Key Success Factors

Proactive risk identification and escalation during manufacturing operations
Timely closure and high-quality management of deviations and investigations
Strong, compliant oversight of CMO operations and quality systems
Effective cross-functional collaboration and governance leadership
Continuous improvement of quality systems and performance metrics

Additional Information

Hybrid schedule based at the company's Somerville, Massachusetts headquarters, with on-site presence expected (three) days per week
On-call QA support for manufacturing operations
Prolonged periods of computer-based work.
Occasional travel
This position has no direct reports

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

Apply Now

Refine Your Search

quality control associate jobs in framingham ma

Associate Manager, Quality Assurance Operations

Associate Director, Analytical Development & Quality Control

Associate Director, Quality Control

Inventory Control & Quality Assurance (ICQA) Associate

Associate Director, Analytical Development and Quality Control

Associate Director, Quality Control Lab Automation

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