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    Research Development Quality And Risk Management Inspection Management Lead (All Genders)

    Merck Kgaa
    8+ years
    Not Disclosed
    Mumbai
    10 Dec. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills:

    Job Title: Inspection Management Lead, Healthcare R&D

    Location: [Location to be specified]

    About Us:

    At [Company Name], our purpose in Healthcare is to improve, extend, and enhance lives by developing medicines, intelligent devices, and innovative technologies in therapeutic areas such as Oncology, Neurology, and Fertility. Our teams are united across 6 continents, fueled by passion and curiosity, working relentlessly to help patients at every stage of life. Joining our Healthcare team means becoming part of a diverse, inclusive, and flexible working culture, offering great opportunities for personal development and global career advancement.

    Your Role:

    As the Inspection Management Lead, you will play a key role in coordinating all activities related to Health Authority inspections across Healthcare R&D. You will manage inspections related to GCP, GLP, and GVP for various R&D projects or facilities. This includes everything from pre-inspection setup, hosting inspections, coordinating responses, and ensuring timely follow-up and CAPA completion. You will also oversee proactive inspection readiness strategies, providing leadership and strategic direction across inspection processes worldwide.

    Key Responsibilities:

    • Inspection Coordination:

      • Lead the preparation, execution, and close-out of all GCP/GLP/GVP Health Authority inspections.
      • Coordinate inspection setup activities with internal teams and external partners.
      • Establish and maintain communication with inspectors, ensuring all information is collected and clarified as needed.

    • Inspection Hosting & Operational Support:

      • Host or participate in inspections, providing operational support across inspection teams (Front Room, Back Room, etc.).
      • Create and distribute daily inspection summaries and response reports.
      • Assign Subject Matter Experts (SMEs) and lead response team meetings.

    • Inspection Data Management & Reporting:

      • Record inspection data and ensure it is entered into the electronic system per established processes.
      • Provide regular reports on inspection status, global responses, and CAPA completion.
      • Ensure efficient communication across stakeholders, tracking and ensuring closure of all inspection-related actions.

    • Proactive Inspection Readiness:

      • Develop and oversee inspection readiness strategies, ensuring project teams are well-prepared.
      • Conduct mock inspections and assessments of inspection readiness.
      • Drive knowledge sharing, lessons learned, and the development of best practices for future inspections.

    • Inspection Intelligence & Process Improvement:

      • Maintain and monitor inspection intelligence, keeping up-to-date with the latest trends and regulatory expectations.
      • Ensure that inspection processes, tools, and communication strategies are standardized and harmonized globally.

    • Regulatory & Compliance Expertise:

      • Contribute to the development of internal R&D procedures and quality strategy.
      • Provide input on industry regulations, ensuring compliance with global standards, including GxP areas (GCP, GLP, GVP, GMP, GDP).

    Who You Are:

    Education & Experience:

    • Required:
      • Minimum Bachelor’s degree, preferably in a scientific or quality-related field.
      • 8+ years of experience in Quality Assurance (QA) or relevant experience in the pharmaceutical or biotech industry, with at least 5 years in Clinical QA.
      • Extensive experience with Regulatory Authority inspections, including FDA, EMA, MHRA, PMDA, and others.
      • Strong knowledge of GxP (GCP, GLP, GVP), drug development processes, and regulatory guidelines.

    Skills & Competencies:

    • Inspection Management:

      • Proven experience in managing and coordinating inspections, with a deep understanding of global regulatory processes.

    • Leadership & Collaboration:

      • Ability to lead and coordinate international teams under pressure, providing guidance and support during inspections.
      • Strong interpersonal and communication skills, with the ability to influence, negotiate, and manage stakeholders effectively.

    • Problem-Solving & Strategic Thinking:

      • Ability to address critical issues during inspections, maintaining quality and business perspective.
      • Demonstrated ability to work independently, manage time effectively, and adapt to changing business needs.

    • Cultural Awareness & Adaptability:

      • Understanding and appreciation of cultural differences and their impact on team behavior.
      • Stress resilience and flexibility in managing challenging situations.

    What We Offer:

    We are committed to creating a culture of inclusion and belonging, empowering everyone to contribute their best selves to our mission. We value diverse backgrounds, experiences, and perspectives, knowing they drive excellence and innovation. With access to career development opportunities and a supportive, flexible working environment, you will be able to grow both personally and professionally.

    If you are ready to make an impact in the field of Healthcare R&D and drive the future of inspection management, apply now and become part of our diverse team that champions human progress!

    Apply Today and Join Us in Building a Healthier Future!

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