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    Lead, Quality Assurance

    Abbvie
    8+ years
    Not Disclosed
    Bengaluru
    10 Dec. 31, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    The Quality Assurance Lead at AbbVie is responsible for overseeing and driving the quality strategy for clinical research activities within designated countries and regions. This role involves collaboration with various stakeholders in clinical research, regulatory affairs, and quality management to ensure adherence to local and global regulatory standards, as well as AbbVie's internal policies and procedures.

    Key Responsibilities:

    1. Collaboration & Relationship Management:

      • Develop and maintain strong, collaborative relationships with clinical development leaders and RDQA functions to ensure alignment with the AbbVie Quality System.
      • Work with Affiliates to advance AbbVie's quality standards and drive first-pass approval for market authorization by health authorities.

    2. Quality & Compliance Oversight:

      • Oversee quality and compliance in clinical research, ensuring adherence to AbbVie policies and regional regulations.
      • Lead risk identification and mitigation strategies for clinical trials in the assigned regions, fostering continuous improvement and regulatory preparedness.

    3. Audit & Inspection Readiness:

      • Manage the governance and oversight of clinical research activities, ensuring they are fit for purpose.
      • Develop and execute inspection strategies and provide inspection-readiness support for Health Authority inspections.
      • Conduct audits to assess compliance and communicate findings effectively, including managing corrective action plans.

    4. Regulatory & Risk Management:

      • Identify trends and potential risks in clinical research and develop strategies to mitigate them.
      • Ensure alignment with regulatory requirements and provide guidance on regulatory expectations.
      • Support local and regional Health Authority inspections, and participate in these inspections as necessary.

    5. Mentorship & Team Leadership:

      • Provide guidance and mentorship to AREA Managers and associates, helping to build leadership capacity within the team.
      • Lead and influence cross-functional teams to drive performance and ensure successful execution of quality strategies.

    Qualifications:

    • Education: Bachelor's degree in Biology, Nursing, Pharmacy, or related medical science field. Equivalent technical experience is also considered.

    • Experience:

      • 8+ years in the biopharmaceutical or medical device industry, with at least 3 years in leadership roles.
      • Experience in quality assurance, compliance, regulatory affairs, or clinical research.
      • Strong understanding of local and global regulatory requirements, quality systems, and auditing standards.

    • Skills:

      • Strong leadership and influencing abilities, particularly in cross-functional collaboration.
      • Excellent written and oral communication skills, with the ability to present and negotiate effectively.
      • Strong analytical and organizational skills, with a proven track record of managing complex processes.
      • Ability to adapt quickly to changes in regulatory environments.

    • Additional:

      • Fluency in additional languages is desirable.
      • Ability to travel as needed (up to 35%).

    Additional Information:

    • Equal Opportunity Employer: AbbVie is committed to diversity and inclusion, providing equal opportunities regardless of race, color, religion, national origin, sex, gender identity, disability, and other protected statuses.

    This role is ideal for professionals with extensive experience in clinical quality assurance and regulatory compliance, looking to take on a leadership role in driving AbbVie’s quality strategy for clinical research.

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