Director, Clinical Process Compliance

GCP Compliance And Quality Leader

Drives vision, strategic oversight, and operational delivery of Gcp compliance and quality principles related to clinical trial execution. Ensures clinical studies are successfully implemented through a strong foundation of Gcp compliance, governing quality system documentation, and quality control of processes. Accountable for the end-to-end clinical trial business continuity process and escalation of business-critical decisions to senior leadership across R&d during times of crisis. Instills an inspection readiness culture enabling natural everyday compliance in support of successful inspection outcomes and on-time product approvals. Accelerates patient impact by delivering operational excellence to meet evolving business needs through collaborative partnerships, and a proactive, balanced, and innovative compliance approach. Demonstrates excellence in people leadership and development, and working in a matrixed environment.

• This role requires onsite work at AbbVie locations. The expected onsite days are Tuesday, Wednesday, and Thursday each week.

Illinois (IL) : North Chicago, Massachusetts (MA) : Worcester, New Jersey (NJ) : Branchburg, Florham Park, California (CA) : Irvine, South San Francisco

Effectively identifies and leads high performing team of Gcp compliance experts who position the organization for successful clinical trial execution outcomes including inspection success and on-time product approvals.

Partners with development leaders to align on strategy for delivery of Gcp compliance and quality principles to meet immediate and evolving business needs and regulatory expectations.

Instills a culture of inspection readiness across the development organization through a pro-active and balanced compliance approach.

Develops the strategy and operational approach for inspection preparation, conduct, and close activities including review of the response submitted to the regulatory agency.

Ensures tracking and implementation of commitments from inspections and appropriate compliance / inspection support of clinical operation functions

Oversees the establishment, maintenance, and monitoring of compliance metrics in support of senior leader review and the quality management review process. Accountable for interpretation and escalation of compliance metric signals, risks, and trends that have potential impact on successful clinical trial outcomes.

Informs senior leaders regarding health of clinical trial execution during time of crisis including risks to successful clinical trial outcomes and process / regulatory compliance. Escalates business-critical decisions needed to support business continuity to senior leadership for review, leads resolution, and mitigation efforts as applicable.

Represents development in compliance and quality-related committees and initiatives including company-wide strategic and industry benchmarking discussions. Connects with compliance and quality leaders across R&d to share relevant information, best practices, and latest compliance-related industry and regulatory intelligence.

Responsible for active management of the compliance resource model, identifying risks and potential efficiencies to ensure business needs and budgetary expectations are met and aligned with strategic direction.

This position will have direct reports and may have oversight of external resources

Bachelor's degree (or ex-us equivalent) is required; advanced degree preferred

10+ years of pharmaceutical, healthcare, or clinical research related experience; compliance or quality experience within highly regulated industry preferred

5+ years of people leadership experience, or extensive evidence, demonstrating successful leadership in highly dynamic, global, and matrixed environment

Demonstrates excellence in people leadership and development, leading cross-functional teams, and fostering global team productivity and cohesiveness

Able to translate organizational vision and mission into operational strategy, plan, and execution

Considered a subject matter expert and competent in the application of AbbVie's quality manual principles, standard business procedures, and Gcp-related regulations

Senior leaders within clinical development operations, regulatory, quality assurance, pharmacovigilance, legal, data & statistical sciences, clinical drug supply management, tamd program and study teams