Quality Assurance Manager

Job Title: Quality Assurance Manager Job Description This role leads and supports quality assurance and quality control activities for biologics, with a strong focus on GMP compliance, method development, and batch record oversight. The Quality Assurance Manager contributes directly to drug manufacturing processes, partners closely with internal teams and external CMOs, and helps shape quality methods and systems that will be used for years to come. Responsibilities

- Support quality control activities, including testing and method development for biologic products.
- Perform detailed batch record reviews for internal manufacturing operations and external CMO partners to ensure accuracy, completeness, and compliance with GMP standards.
- Participate in and support batch disposition activities for drug manufacturing processes.
- Conduct and support investigations, including root cause analysis, and contribute to the implementation and follow-up of corrective and preventive actions (CAPAs).
- Assist in the development, review, and maintenance of QC methods to ensure they remain robust, reliable, and compliant.
- Support and assist with change control activities, ensuring appropriate documentation, risk assessment, and implementation tracking.
- Oversee and review quality data, including stability control and other QC data, to support product quality decisions.
- Contribute to the continuous improvement of the quality management system (QMS) and related quality processes.
- Provide quality oversight for contract manufacturing organizations (CMOs), including review of quality documentation and coordination of quality-related activities.
- Collaborate closely with QC departments and internal analytical development/quality control (AD/QC) teams to ensure alignment on quality standards and practices.
- Support biologics and drug manufacturing operations by providing quality guidance and ensuring adherence to regulatory and internal quality requirements.
- Act as an individual contributor with managerial-level responsibilities for quality activities, without direct people management duties.

Additional Skills & Qualifications

- Bachelors degree (BS) in a life science discipline.
- Experience supporting biologics companies and drug manufacturing organizations.
- in stability control and data review for biologic products.
- Familiarity with quality systems specific to clinical-stage biologics (e.g., stage II molecules).
- Experience contributing to the development and refinement of QC methods and quality processes that will be used long term.
- Ability to thrive in a growing environment with broad exposure to multiple molecules and projects.

Work Environment The role is 100% onsite, Monday through Friday, from 9:00 a.m. to 5:00 p.m. You will work closely with quality control departments and the internal analytical development/quality control (AD/QC) team in a collaborative, growth-oriented environment. The organization offers a strong culture and supportive work setting, with significant exposure to various clinical-stage biologic molecules and the opportunity to influence methods and quality practices that will be used for years to come. This position is structured as an individual contributor role with managerial-level responsibilities over quality activities, but without direct people management responsibilities.
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)
Job Type & Location
This is a Contract position based out of Lexington, MA.
Application Deadline
This position is anticipated to close on Nov 18, 2026.
Workplace Type
This is a fully onsite 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 [email protected] 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.