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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Head, Compliance & Ethics

Bengaluru, Karnataka, India Req ID 2212044 Category Compliance Division AbbVie
  • Provides direction to staff of professionals to include hiring, setting performance expectations, performance feedback and development of staff.
  • Directs the development of Quality policies that meet both regulatory and company requirements.
  • Maintains expertise on various regulations (FDA, EMA, ICH, etc.)
  • Reviews and approves key quality documents.
  • Provides compliance leadership to the manufacturing site.
  • Provides direct interface with FDA and other regulatory agencies. Develops and communicatestone for successful, cooperative inspection. Directs any and all resources necessary to participate in audit.
  • Compiles, analyzes and communicates significant quality or compliance metrics to senior management.
  • Interacts directly with regulatory agencies and clients during inspections.
  • Establish programs to promote quality awareness and compliance.

  • Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required.
  • 8+ years of Biopharmaceutical experience
  • Demonstrated ability to effectively interface with regulatory agencies
  • Quality Assurance/Regulatory Affairs/Compliance experience required
  • Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
  • Able to demonstrate extensive knowledge of plant and company level procedures.
  • Ability to evaluate quality, production and support areas for compliance to GMPs. BOPs, etc.
  • Strong decision making
  • Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

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