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

    Merck Kgaa
    8+ years
    Not Disclosed
    Mumbai
    10 Dec. 31, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Work Your Magic with Us!

    Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe are passionate about innovating with science and technology to enrich lives through solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are committed to caring for our diverse mix of people, customers, patients, and the planet. That’s why we’re always looking for curious minds to imagine the unimaginable with us.

    United As One for Patients:
    Our purpose in Healthcare is to help create, improve, and prolong lives. We develop medicines, intelligent devices, and innovative technologies in therapeutic areas such as Oncology, Neurology, and Fertility. Our teams, across 6 continents, work passionately with relentless curiosity 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.

    Role: Healthcare R&D Inspection Lead
    Location: [Insert Location]

    Key Responsibilities:

    • Coordinate the preparation, execution, and closeout of all GCP/GLP/GVP Health Authority Inspections for Healthcare R&D projects and facilities.
    • Lead and coordinate pre-inspection activities with Healthcare R&D stakeholders and external partners.
    • Prepare and educate internal and external teams on inspection management processes.
    • Set up inspection activities by establishing communication with inspectors, collecting necessary information, and clarifying the inspection agenda.
    • Host or participate in inspections, providing full operational support (e.g., Front Room, Back Room).
    • Coordinate responses to pre-inspection requests, daily summaries, and the creation of inspection responses.
    • Assign subject matter experts, lead response team meetings, and ensure timely response to inspectors.
    • Record inspection data in the electronic system, ensuring adherence to established processes.
    • Collaborate with RDQ to track and close corrective actions and preventive measures based on inspection outcomes.
    • Oversee and maintain proactive inspection readiness strategies, including tools, project readiness, and training approaches.
    • Ensure an effective and controlled inspection process across Healthcare R&D globally.
    • Drive knowledge sharing and lessons learned from past inspections to continuously improve practices.
    • Maintain up-to-date inspection intelligence and identify emerging inspection trends or issues.
    • Develop and implement standardized tools for inspection preparation, conduct, reporting, and follow-up.

    Required Experience & Training:

    • Minimum Bachelor’s degree (advanced degree preferred) in a scientific or quality-related subject.
    • At least 8 years of relevant QA experience in the pharmaceutical or biotech industry, with a minimum of 5 years in Clinical QA.
    • In-depth knowledge of GxP areas (GCP, GLP, GVP), regulatory authorities’ inspections, and drug development processes.
    • Strong experience with regulatory authorities such as FDA, EMA, MHRA, and PMDA.
    • Medical expertise preferred to assess the potential consequences of detected issues and proposed measures.
    • Proven ability to lead and influence international inspection teams, with excellent interpersonal, organizational, and problem-solving skills.
    • Ability to work independently, manage time effectively, and adapt to changing business needs.
    • Stress resilience and flexibility in high-pressure inspection conditions.
    • Fluency in written and spoken English.

    What We Offer:

    We value diverse perspectives and believe they drive excellence and innovation. Join us to be part of a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.

    Apply now and become a part of our diverse team!

    US Equal Employment Opportunities:
    The Company is an Equal Employment Opportunity employer. No employee or applicant will be discriminated against on any basis, including race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable law.

    North America Disclosure:
    If you are a resident of California, Colorado, Hawaii, Maryland, New York, Washington, or Washington, DC, you may be eligible to receive additional information about compensation and benefits upon request. Contact 855-444-5678 from 8:00 am to 5:30 pm ET, Monday through Friday for assistance.

    Notice on Fraudulent Job Offers:
    Be cautious of third parties impersonating our company to offer unauthorized job opportunities. Please refer to our official website for more information if you suspect a fraudulent job offer.

    What We Offer:

    • Saving & Financial: Our 401(k) plan includes company matching contributions and additional discretionary contributions each year. We also offer tax-advantaged accounts for healthcare, commuting, and life insurance.

    • Health & Wellness: Comprehensive medical, dental, and vision coverage, including Telehealth services and free behavioral health counseling.

    • Voluntary Benefits: Additional protection from healthcare costs and discounts on insurance, personal loans, and more.

    • Work/Life Support: Generous paid time off, back-up daycare services, education assistance, and more.

    Our Recruiting Process:

    1. You Apply: Submit your application for the role that matches your qualifications.
    2. We Screen: We review your application and determine if you’re a good fit.
    3. We Assess: We interview you by phone, video, or face-to-face.
    4. Mutual Agreement: If you’re the right match, we hope you’ll join us!
    5. Work Your Magic: We ensure your smooth onboarding process.

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