• Quality Manager

    Actalent (North Billerica, MA)


    Quality Assurance and CMC Specialist

    Hi Everyone-

    We have an incredible opportunity with one of the leading pharmaceutical companies in the world. We are looking for individuals, who are ready to advance their career and we are looking to hire right away!

    Responsibilities

    + Qualify new sites and assist with stability studies.

    + Support technical transfer processes.

    + Review, author, and assist with CMC documents.

    + Conduct site audits and contribute to site qualification efforts.

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

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

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

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

    + Write, review, and approve regulatory CMC submissions.

    + Collaborate on drug development, process control, and analytical method development and qualification.

    Essential Skills

    + Strong knowledge of CMC processes and technical transfer.

    + Experience in validation, quality assurance, and regulatory practices.

    + Ability to author CMC regulatory sections, including INDs and CTAs.

    + Knowledge of radiopharmaceutical drugs and PET GMP guidance.

    + Understanding of FDA regulations for PET drug manufacturing.

    + Familiarity with US cGMP, ICH requirements, and ISO9001 standards.

    Additional Skills & Qualifications

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

    + 2 years of experience in the pharmaceutical industry.

    + Strong experience in authoring CMC regulatory sections.

    + Working knowledge of US regulatory regulations.

    Work Environment

    The role requires onsite work 3 days a week with some flexibility. You will join a small team of 3 people, allowing significant decision-making power and influence on CMC decisions. You will closely collaborate with analytical and regulatory teams.

    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 30, 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.