Senior Quality Assurance Consultant

Description

• Provide quality oversight for CMOs, CDMOs, contract laboratories, and critical suppliers.
• Review and approve deviations, CAPAs, change controls, investigations, and risk assessments.
• Support batch disposition and product release activities.
• Lead quality review of manufacturing and laboratory documentation.
• Establish and maintain Quality Agreements and Quality Technical Agreements (QTAs).
• Monitor supplier and CMO performance metrics and drive continuous improvement initiatives.
• Support technology transfer, process validation, and commercial launch activities.
• Conduct supplier audits and support regulatory inspections, customer audits, and internal audits.
• Partner cross-functionally with Manufacturing, Technical Operations, Supply Chain, Regulatory Affairs, Quality Control, and Process Development teams.
• Ensure compliance with FDA, EMA, ICH, and other applicable global regulatory requirements.
• Drive inspection readiness and maintain a state of continuous compliance.
• Escalate quality risks and implement mitigation strategies to protect product quality and supply continuity.

Skills

Quality assurance, Compliance, Audit, Gmp, Capa, Deviation, change control, FDA, EMA, Deviations, CMO, CDMO

Additional Skills & Qualifications

Bachelor"s degree in Life Sciences, Chemistry, Biology, Biochemistry, Engineering, or related discipline required.

8+ years of pharmaceutical, biotechnology, or biologics quality experience.

3+ years of direct experience supporting CMOs/CDMOs.

Experience Level

Expert Level

Job Type & Location

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

Pay and Benefits

The pay range for this position is $70.00 - $90.00/hr.

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)

Workplace Type

This is a fully onsite position in Waltham,MA.

Application Deadline

This position is anticipated to close on Jul 17, 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 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 actalentaccommodation@actalentservices.com 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.