Associate Vice President - Global Product Complaints Management

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:
The Associate Vice President is responsible for leading a team of employees that provide quality management and oversight of the global consumer product complaint quality system and related product safety surveillance activities.  The AVP is responsible for the development of global complaint management strategies / systems and leads a team of employees that process product complaints, analyze and interpret information including but not limited to product complaints and technical product inquiries with the intent to educate and drive process improvements globally.  The AVP is accountable for global product complaints management, periodic review and continuous improvement, global capabilities and technical teams, global process and standard ownership, and global vendor oversight.

Key Objectives / Deliverables:

• Partner cross functionally with senior leadership to develop a shared vision for end-to-end Global Product Complaints Management that assures effective product safety surveillance and strategically positions Quality to enable business strategies and goals.  Develop, maintain and execute the priorities from the global strategic plan for complaints management.
• Build and maintain strong working relationships with the senior leadership of multiple business components across the enterprise whose teams are involved in the end-to-end management of product complaints and holistic product safety surveillance (e.g., MQO, GPS, Commercial Manufacturing and Quality, Consumer Experience, and Medical Affairs), and collaborate with Brand Leaders on strategies to improve customer experiences with Lilly products.
• Assure each area is appropriately resourced and executes functions compliantly.
• Oversee the direction of the organization with a focus on continuously optimizing the quality system, based on internal learning, industry practice and regulatory requirements to assure compliance with applicable external regulations and internal quality standards; ensure a focus on continuously optimizing the complaint process, based on industry practice and regulatory requirements.
• Monitor and assess the evolving external regulatory environment to anticipate required changes to quality systems and the strategic approach to management of quality. 
• Ensure the establishment and ongoing monitoring of quality performance metrics on complaints across manufacturing and quality.  Ensure corrective and preventive actions are developed and implemented, as appropriate.
• Accountable for governance of Product Complaints process performance and outcomes, and contribution of timely and reliable Product Complaints inputs to quarterly Integrated Management Review.
• Lead the administration of the department, including completing performance management, participating in talent assessment and succession planning, providing development opportunities, rewarding & recognizing employees, supporting diversity in recruitment & development, and resolving personnel or other HR related events.

Basic Requirements:

Bachelor’s degree in science, engineering or healthcare-related profession with the following experience:

• Minimum of 10 years of experience in the pharmaceutical or other regulated industry with demonstrated knowledge and application of applicable regulations and related quality systems.
• Minimum of 5 years of leadership experience, preferably in Quality Assurance.

Doctorate degree in science, engineering or healthcare-related profession with the following experience:

• Minimum of 8 years of experience in the pharmaceutical or other regulated industry with demonstrated knowledge and application of applicable regulations and related quality systems.
• Minimum of 4 years of leadership experience, preferably in Quality Assurance.

Demonstrated ability to lead people and build organizations; demonstrated ability to coach and develop personnel to achieve operational excellence.

Additional Skills/Preferences:<