About this role
Job Title: Quality Assurance ManagerJob DescriptionWe are seeking a Quality Assurance Manager to support quality operations for clinical-stage biologics manufacturing. This role focuses on GMP compliance, batch record review, quality investigations, QC method support, change controls, stability data review, and oversight of external manufacturing partners (CMOs). This is an individual contributor position with managerial-level responsibilities and no direct reports.
Key Responsibilities
- Review batch records and support batch disposition activities for internal manufacturing and CMOs
- Lead investigations, root cause analyses, and CAPA implementation
- Support QC testing, method development, and stability data review
- Manage change controls and quality documentation
- Provide quality oversight for biologics manufacturing operations and external partners
- Collaborate with QC and AD/QC teams to maintain quality standards
- Drive continuous improvement of quality systems and processes
Qualifications
- BS in Life Sciences or related field
- Experience in biologics manufacturing and GMP-regulated environments
- Experience in batch record review, investigations, CAPAs, and quality systems
- Experience with stability programs, QC methods, and data review
- Familiarity with clinical-stage biologics and CMO oversight
- Able to thrive in a fast-paced, growing organization
Work Environment
- 100% onsite, Monday-Friday, 9:00 AM to 5:00 PM
- Collaborative environment with strong exposure to multiple biologic programs
- Opportunity to help shape long-term quality methods, systems, and processes within a growing organization
Job Type & LocationThis is a Contract position based out of Lexington, MA.
Pay and BenefitsThe 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 DeadlineThis position is anticipated to close on Nov 20, 2026.
Workplace TypeThis 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.