Associate Director - Quality Compliance - Indianapolis Device Manufacturing

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$118,500 - $173,800

Organization Overview:
The Associated Director - Quality Compliance role is part of the Lilly Pharmaceutical Delivery Systems (PDS) Quality Systems and Regulatory Compliance Team. The team provides support and oversight of the Lilly Indy Device Manufacturing (IDM) and PDS devices network of global sites and internal/external suppliers.

Responsibilities:

The Associate Director - Quality Compliance will have responsibility for leadership of the auditing, learning and development, and purchasing controls functions within the Indy Device Manufacturing team. As part of the internal/external audit and site self-inspection programs, the audit team performs audits of both internal IDM functions and internal and external PDS suppliers/contract manufacturers to provide oversight of these areas and organizations and ensure compliance with governing standards and regulations. The position oversees the learning and development team, which is responsible for implementation of procedures, training, and associated learning management system administration across the IDM site and associated resources. Further, this position is responsible for execution of the Purchasing Controls and Supplier Management Quality System and associated resources.

• Ensure an adequate number of qualified resources are available to perform quality assurance activities in support of IDM Quality operations and oversight of quality compliance activities to include auditing, learning and development, and purchasing controls functions

• Ensure adherence to the quality policy and objectives for the site

• Provide technical understanding and internal/external communication (throughout various functions and organization levels) regarding the Quality Management System to ensure on-going management of quality system requirements in order to maintain compliance and drive continuous improvement activities

• Participate in and respond to regulatory agency and self-inspections internal to IDM as well as providing support to quality audits

• Manage internal/external audit and site-self inspection resourcing, alignment with corporate auditing function, where applicable

• Responsible for development and maintenance of IDM Purchasing Controls and Learning & Development systems

• Review/approve or reject procedures and training, change proposals, purchasing controls documentation, deviations, and ensure implementation of appropriate corrections/CAPA and effectiveness checks

• Mentor, coach and provide feedback to team members and cross-functional partners

• Collaborate to drive and influence continuous improvement impacting compliance and operational excellence, including through support of network and functional initiatives

• Participate in organizational and business planning activities

• Exhibit cross-functional influence

• Aid in human resource planning, development and performance management for direct reports

• Other duties as required

Basic Requirements:

• Bachelor’s Degree (or equivalent work experience)

• Minimum of five (5) years industry related experience in areas which may include Quality, Technical Services, and/or Manufacturing

• Experience with governing standards and regulations (e.g., 21CFR Part 4, Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU MDR, JPAL)

Additional Skills/Preferences:

• Demonstrated leadership capability

• Demonstrated interpersonal skill for working with cross-functional teams, suppliers and contract manufacturers

• Ability to influence diverse groups

• Demonstrated oral and written communication

• Demonstrated self-management/time-management skills

• Demonstrated ability to meet commitments and deadlines

• Demonstrated decision-making and problem-solving skills

• Ability to work as part of a team

• Demonstrated negotiating coaching and mentori