Associate Director - Inspection Readiness (Hybrid)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Data Management Excellence organization in Clinical Development Strategy and Operations (CDSO) is a newly created entity to design, implement, and oversee the Total Quality Management operating model to achieve current and future financial commitments and ensure quality of deliverables. Centered around Continuous Improvement, Inspection Readiness, and Vendor Strategy. The Associate Director, Inspection Readiness, is a key leader in the Data Management Excellence team responsible for development of Inspection Readiness strategy, oversight of organizational Quality metrics, and tactical compliance related activities. This role is a player/coach, with direct reports as well as individual contributor responsibilities.

Responsibilities:

• Responsible for developing Inspection Readiness strategy, in collaboration with Clinical Process Compliance
• Works with CDSO functional owners and CDO training teams to develop and maintain training strategy and oversight
• Audit and inspection strategy and approach inclusive of internal CDSO “spot audits”
• Ensures tracking and implementation of commitments from audits and inspections, in collaboration with Data Management Excellence and CDSO functional owners
• Operating CDSO Quality governance forum
• Collaborate with Data Strategy and Analytics for development and oversight of Quality-related metrics and dashboards

Qualifications

Minimum Qualifications:

• Bachelor’s degree (or equivalent) required, typically in scientific or engineering field
• 10+ years of Pharma-related experience
• 6+ years experience in regulatory or compliance-related role with knowledge of regulatory in