• Quality Manager: CMC

    Actalent (North Billerica, MA)


    Job Title: Quality Specialist for Site Qualification and Stability StudiesJob Description

     

    We are seeking a dedicated Quality Specialist to support the qualification of new sites and assist with stability studies. The role involves technical transfer, reviewing and authoring CMC documents, site auditing, and maintaining submission information in relevant CMC systems. The successful candidate will manage and contribute to CMC-related projects and initiatives, ensuring compliance with regulatory, scientific, and technical criteria.

    Responsibilities

    + Qualify new sites and assist with stability studies.

    + Support technical transfer processes.

    + Review, author, and assist with CMC documents.

    + Conduct site audits and assist with qualification.

    + Maintain submission information in CMC systems and track project timelines.

    + Manage and contribute to CMC-related projects, initiatives, and actions.

    + Develop and qualify drug development, process control, and analytical methods.

    + Ensure quality assurance and compliance with GMP knowledge, including change control, deviation, and CAPA.

    + Write, review, and approve regulatory CMC submissions.

    + Possess knowledge of radiopharmaceutical drugs.

    + Serve as a CMC representative on core projects, manage project activities, assess risks, and develop strategic plans.

    Essential Skills

    + Experience with CMC, tech transfer, validation, and quality assurance.

    + Proficiency in regulatory processes, SOPs, GMP, and IND.

    + Minimum of 5 years of quality assurance or technical experience in a pharmaceutical or life-science environment with a Bachelor's degree, or 3+ years with a Master's degree.

    + At least 2 years of experience in the pharmaceutical industry with strong skills in authoring CMC regulatory sections, including INDs/CTAs.

    Additional Skills & Qualifications

    + BS in a life science discipline.

    + Working knowledge of PET Good Manufacturing Practice guidance and FDA regulations is preferred.

    + Familiarity with US cGMP, ICH requirements, ISO9001, and US regulatory regulations.

    + Radiopharmaceutical drug knowledge is advantageous.

    Work Environment

    The role requires onsite work 3 days a week, with some flexibility in scheduling. The successful candidate will be part of a small team of 3 people, providing a significant opportunity for decision-making power and influence on CMC decisions. Collaboration with analytical and regulatory teams is essential.

    Pay and Benefits

    The pay range for this position is $165000.00 - $175000.00/yr.

     

    They have 401k, vacation, and holiday. They also have health insurance plans and have a yearly shutdown.

     

    Workplace Type

     

    This is a hybrid position in North Billerica,MA.

     

    Application Deadline

     

    This position is anticipated to close on May 28, 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.