Quality Assurance Supervisor

Job Title: Quality Assurance Supervisor

Job Description

The Quality Assurance Supervisor oversees the release of raw materials and products, including process development, engineering, and clinical trial batches, to support contract development and manufacturing operations. This role establishes and maintains quality procedures and documentation, supports specification and regulatory dossier development, and ensures that all projects comply with current good manufacturing practices and applicable regulatory requirements. The supervisor provides guidance on quality requirements, drives continuous improvement of quality systems, and serves as a key point of contact for customer communications and audits.

Responsibilities

• Release raw materials and products, including process development batches, engineering batches, and clinical trial batches, in support of contract development and manufacturing projects.
• Organize, establish, and maintain relevant quality procedures and documents to ensure consistent and compliant operations.
• Support the development of specifications for contract development and manufacturing projects.
• Collaborate with customers and internal regulatory affairs teams to assist in the preparation of regulatory dossiers that support contract development and manufacturing projects.
• Provide direction and advice on the application and interpretation of quality requirements for contract development and manufacturing projects.
• Draft project-related Quality Agreements and verify organizational compliance with approved Quality Agreements, including coordinating customer notifications when required.
• Track, coordinate, and respond to all customer communications and inquiries related to quality and project execution.
• Lead and support continuous improvement initiatives for cGMP Quality Systems to ensure compliance with FDA, ICH, USDA, ISPE, and other applicable pharmaceutical industry requirements.
• Compile, analyze, and communicate quality and project-related metrics to management as required.
• Participate in internal and external audits, address audit findings, and implement corrective and preventive actions where necessary.
• Perform review and approval of product release documentation and shipping documentation for contract development and manufacturing products.
• Review batch records to ensure completeness, accuracy, and compliance with established procedures and regulatory expectations.
• Support the evaluation, approval, and closure of investigations, CAPAs, and change controls associated with contract development and manufacturing activities.

Essential Skills

• Bachelor's degree in a relevant scientific or technical discipline.
• Minimum of 5+ years of experience in material release, product development and validation, test method development and validation, approval of investigations, quality agreements, and change controls.
• Demonstrated experience in batch record review and quality assurance within a regulated pharmaceutical or biotechnology environment.
• Strong knowledge of FDA regulations and current good manufacturing practices (cGMP).
• Experience with CAPA (Corrective and Preventive Action) processes and audit support.
• Ability to interpret and apply regulatory and industry guidance, including FDA, ICH, USDA, and ISPE requirements.
• Proven ability to manage and respond to customer communications and inquiries in a timely and professional manner.
• Strong documentation, organizational, and procedural development skills.
• Ability to compile, analyze, and report quality metrics to management.
• Excellent written and verbal communication skills for drafting quality agreements and regulatory-supporting documentation.

Additional Skills & Qualifications

• Graduate degree in a scientific or technical discipline is preferred.
• 10+ years of experience including material release, product development and validation, test method development and validation, approval of investigations, quality agreements, and change controls is preferred.
• Experience with biologics and drug substance manufacturing is preferred.
• Experience with Drug Master Files (DMFs) is preferred.
• Familiarity with GLP test activities and support for GLP-related documentation.
• Experience participating in and supporting regulatory and customer audits.
• Ability to work collaboratively with cross-functional teams, including regulatory affairs and external customers.

Work Environment

This role operates primarily on a first-shift schedule, Monday through Friday. The position supports a contract development and manufacturing environment that follows cGMP and GLP principles and interfaces with regulatory requirements from agencies such as FDA, ICH, USDA, and industry organizations such as ISPE. Work involves regular interaction with quality systems, batch records, release documentation, and shipping documentation, as well as collaboration with internal teams and external customers to support compliant and efficient project execution.

Job Type & Location

This is a Permanent position based out of Madison, WI.

Pay and Benefits

The pay range for this position is $70000.00 - $80000.00/yr.

Competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k

Workplace Type

This is a fully onsite position in Madison,WI.

Application Deadline

This position is anticipated to close on Jun 5, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ... for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.