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 . 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 inspection practices
• Proven leadership in both direct team building and indirect / cross-functional influence

Other Required Skills:

• Knowledge of clinical trial lifecycle
• Excellent communication and decision-making skills
• Considered a Subject Matter Expert and competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance, Response Writing)

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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