Quality Assurance Manager

Quality Assurance Manager

This role leads and supports quality assurance and quality control activities for biologics manufacturing, with a strong focus on testing, method development, and robust quality systems. The Quality Assurance Manager reviews and supports batch records, investigations, CAPAs, change controls, and batch disposition activities for both internal manufacturing and external contract manufacturing partners. This position plays a key role in ensuring GMP compliance, maintaining a strong quality management system, and contributing to the development and implementation of QC methods that will support multiple clinical-stage molecules.

Responsibilities:

• Support quality control activities, including product testing, stability control, and analytical method development for biologics.
• Perform detailed batch record reviews for internal manufacturing operations to ensure compliance with GMP and internal quality standards.
• Review batch records and quality documentation from external contract manufacturing organizations (CMOs) and provide oversight to ensure adherence to quality and regulatory requirements.
• Help perform and document investigations related to deviations, nonconformances, and quality events, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPAs).
• Assist with batch disposition activities by reviewing data, documentation, and quality records to support timely and compliant release decisions.
• Support and help maintain the quality management system (QMS), including quality procedures, records, and data review processes.
• Contribute to the development, review, and implementation of QC methods, ensuring they are robust, compliant, and suitable for ongoing use by the quality team.
• Assist with change control activities, including initiation, impact assessment, documentation, and implementation of changes to processes, methods, or systems.
• Collaborate closely with QC departments and internal analytical development/quality control (AD/QC) teams to ensure alignment on testing strategies, data review, and quality expectations.
• Provide quality oversight for CMOs by reviewing quality data, documentation, and performance, and by supporting effective communication and issue resolution.
• Support biologics and drug manufacturing operations by ensuring that quality requirements are clearly defined, communicated, and followed.
• Contribute to the continuous improvement of quality processes, documentation practices, and data review activities.
• Act as an individual contributor with managerial-level responsibility for quality activities, without direct people management, while influencing cross-functional teams through strong communication and collaboration.

Essential Skills:

• 10-15 years of experience working in a quality capacity within the life sciences or biopharmaceutical industry.
• Bachelors degree (BS) in a life science discipline.
• Extensive experience in quality assurance (QA) and quality control (QC) roles, supporting biologics or drug manufacturing companies.
• Strong experience in GMP (Good Manufacturing Practice) environments and quality management systems (QMS).
• Hands-on experience with batch record review for internal manufacturing operations.
• Proven experience in managing and overseeing CMOs, including review of their batch records and quality documentation.
• Demonstrated experience with investigations, root cause analysis, and corrective and preventive actions (CAPA).
• Experience with change control processes in a regulated environment.
• Familiarity with QC method development and method review for biologics.
• Strong skills in data review and documentation practices within a regulated quality environment.
• Excellent communication skills with the ability to work effectively with a variety of stakeholders.
• Demonstrated ability to work hard, collaborate well, and maintain positive working relationships across teams.

Additional Skills & Qualifications:

• Experience supporting multiple biologic molecules at clinical stages, including stage II development.
• Experience in stability control and related quality activities for biologic products.
• Experience working closely with internal QC and analytical development teams.
• Ability to contribute to the design and implementation of QC methods that will be used long term by the quality organization.
• Strong organizational skills and attention to detail when reviewing data, documentation, and quality records.
• Ability to operate as an individual contributor while taking ownership of key quality processes and decisions.

Work Environment:

This position is a full-time, 100% onsite role, working Monday through Friday from 9:00 a.m. to 5:00 p.m. The Quality Assurance Manager works closely with QC departments and internal AD/QC teams in a collaborative and supportive environment. The culture emphasizes growth, exposure to a variety of clinical-stage molecules, and the opportunity to shape QC methods that will be used for years to come. The work setting is professional, team-oriented, and focused on high-quality standards, open communication, and strong cross-functional collaboration.

Job Type & Location:

This is a Contract position based out of Lexington, MA.

Pay and Benefits:

The pay range for this position is $60.00 - $80.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline:

This position is anticipated to close on Nov 3, 2026.

Workplace Type:

This is a hybrid position in Lexington, MA.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 View email address on click.appcast.io 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.