Job Title: Quality Assurance Leader – Biopharma/CDMO

Overview:

We are seeking a dynamic and experienced Quality Assurance (QA) leader to oversee our Quality team and ensure compliance with regulatory standards and internal quality systems. This role is critical in driving excellence across all QA functions, including audits, CAPA management, and FDA readiness, while fostering a culture of continuous improvement.

Key Responsibilities:

Lead and manage all QA operations, including documentation control, internal and external audits, investigations, and regulatory compliance.Maintain and continuously improve quality systems in accordance with GMP, GxP, and FDA requirements.Oversee CAPA processes, ensuring timely and effective resolution of quality issues.Collaborate cross-functionally with manufacturing, operations, and other departments to support quality initiatives and operational efficiency.Provide strategic direction, mentorship, and development opportunities for the Quality team.Prepare for and lead regulatory inspections and ensure organizational readiness.

Qualifications:

Proven leadership experience in Quality Assurance within biopharma or CDMO environments.Bachelor’s degree or higher in a Life Science discipline.Deep understanding of GMP, GxP, and FDA regulations.Demonstrated success managing CAPA systems and regulatory audits.

Top Skills:

Quality Assurance LeadershipAudit & Inspection ManagementFDA ComplianceCAPA OversightGMP/GxP ExpertiseCDMO Operational Knowledge

Pay and Benefits

The pay range for this position is $100.00 - $140.00/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 hybrid position in Lexington,MA.

Application Deadline

This position is anticipated to close on Aug 8, 2025.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.