Senior Manager - R&D External Partners Oversight (ExPO)

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

Purpose:

Primarily responsible for providing leadership and direction and performing evaluations for compliance with worldwide regulatory requirements; providing relevant and constructive evaluation of Clinical external suppliers that provide materials and services to AbbVie.

Provides leadership, direction, and execution in compliance and quality; assures that activities are performed and documented in accordance with applicable worldwide quality and regulatory requirements, e.g.: Good Clinical Practice (GCP), to assure quality, effectiveness and safety of our medical device, clinical materials, and drug development suppliers.
 

Responsibilities:

• Assess compliance with applicable regulations through supplier oversight activities. The strategic focus is for early detection and prevention, followed by correction of issues.
• Interpret, explain, and apply applicable current governmental regulations, guidelines, policies, and procedures as applicable to associated activities.
• Manage Clinical Quality Agreement life cycle; lead the creation of the Clinical Quality Agreement; lead the conduct of cross-functional periodic review evaluations of Clinical Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Clinical Quality Agreements, as applicable
• Provide an active role within R&D as an expert in GCP requirements.
• Collaborate with R&D functional areas and assist in the resolution of external supplier quality issues.
• Prioritize activities to ensure objectives of studies/programs are met. Maintain project oversight to include awareness of project timeliness.
• Lead or participate in tec