• Head Of Quality

    Actalent (Lexington, MA)


    Job Description:

    Lead and manage the Quality Assurance (QA) team, overseeing all aspects of quality systems and regulatory compliance. This role is responsible for maintaining and continuously improving QA processes, ensuring alignment with FDA regulations, GMP/GxP standards, and CDMO operations. The ideal candidate will bring extensive leadership experience and a strategic approach to quality management.

    Key Responsibilities:

    + Direct and oversee the Quality Assurance team and daily operations

    + Ensure compliance with FDA regulations, GMP, GxP, and internal quality standards

    + Manage audits, CAPA processes, and quality documentation

    + Support and maintain QA systems including LIMS and TrackWise

    + Collaborate cross-functionally to uphold quality standards across departments

    + Provide guidance and mentorship to QA staff

    Core Skills:

    + Quality Assurance and regulatory compliance

    + Audit management and FDA interaction

    + CAPA development and implementation

    + CDMO experience and GMP/GxP knowledge

    Additional Qualifications:

    + Bachelor’s degree in Life Sciences or related field

    + 15–20+ years of experience in Quality Assurance

    + 15+ years in a leadership role within QA

    + Proficiency in LIMS, TrackWise, and other quality systems

    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 14, 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 [email protected] (%[email protected]) for other accommodation options.