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 technically complex and strategic cross functional projects.
• Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards.
• Achieve a difficult balance of involvement, independence, and objectivity.
• Collect, analyze, and report metrics pertaining to External Partners Quality
• Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality.