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["Manager, Global Inspection Management","Manager, Global Inspection Management"]

Tandym Group

  • Bedford
  • 5 days ago

    Highlights

    A biotech organization is seeking a new Manager, Global Inspection Management to join their team, focusing on global GMP inspection readiness, regulatory inspection support, and cross-functional coordination across internal operations and external manufacturing sites. Partner with Quality, Manufacturing, Supply Chain, Regulatory Affairs, and Compliance teams to strengthen inspection readiness and alignment.

    Numbers & Facts

    LocationBedford
    IndustryStaffing/Employment Agencies
    Company Size100 to 499 employees
    Year Founded1985
    Websitehttp://www.tandymgroup.com

    Description

    A biotech organization is seeking a new Manager, Global Inspection Management to join their team, focusing on global GMP inspection readiness, regulatory inspection support, and cross-functional coordination across internal operations and external manufacturing sites.

    About the Opportunity:

    • Schedule: Monday-Friday
    • Hours: Standard business
    • Setting: Remote
    Responsibilities:
    • Support the implementation of a global GMP inspection management framework and governance model.
    • Lead inspection readiness initiatives across internal and external manufacturing and testing sites.
    • Develop and maintain inspection storyboards, playbooks, mock inspection protocols, and response templates.
    • Support regulatory GMP inspections, including coordination, real-time response management, and post-inspection follow-up.
    • Partner with Quality, Manufacturing, Supply Chain, Regulatory Affairs, and Compliance teams to strengthen inspection readiness and alignment.
    Qualifications:
    • Bachelor's degree in Life Sciences or a related field.
    • 10+ years of experience in GMP compliance, quality assurance, or regulatory affairs within the biopharmaceutical industry.
    • Proven track record of leading global regulatory inspections and readiness programs.
    • Strong knowledge of global GMP regulations and inspection practices.
    • Experience with both internal operations and external manufacturing oversight.
    • Excellent communication and project management skills.
    • Ability to influence across levels and functions in a matrixed organization.
    • Experience with biologics or gene therapy manufacturing.
    • Prior experience working with global CMOs and managing complex supply chains.
    Desired Skills:
    • Familiarity with digital tools for inspection management and quality systems.
    • Experience delivering inspection training programs for SMEs and inspection teams.
    • Exposure to inspection trend analysis and regulatory intelligence.
    • Experience driving continuous improvement in inspection readiness processes and tools.

    About Company

    At Tandym Group (formerly The Execu|Search Group), we’re committed to connecting talented people like you with leading companies. With our personalized approach, you’ll never feel like just a resume when you work with us. We know that every job—and every job seeker—is different, which is why we keep the focus on you and your goals. This philosophy has allowed us to help thousands of people find career success over the last three decades, and we’re here to help you do the same.
    With our extensive network of companies and full suite of direct hire recruitment and contract staffing services, you’ll have access to a variety of roles. We match talent with highly curated opportunities across healthcare, professional services, tech, and life sciences—but it goes far beyond that.
    When you partner with us, we’re all in. Your goals become our goals, and we are committed to helping you reach your highest potential. From matching you with your dream role to providing resume guidance and interview prep, we’re here for the entire journey. In the constantly changing world of work, you can count on us to be by your side.

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