Sr Director - Global Quality - Supplier and Materials Management US, Indianapolis IN

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.

Overview:
The Senior Director, Global Quality – Supplier and Materials Management, is a member of the Global Quality team and is the primary Global Supplier Quality Management partner to Lilly manufacturing networks and sites.  The Senior Director collaborates closely with Global Supply Chain, Technical Services and Procurement in the management and oversight of global suppliers and engages in the resolution of issues with suppliers with the shared goal of ensuring Lilly’s global pharmaceutical supply chain operates effectively and efficiently and that our products meet the highest quality standards.

Responsibilities:

• Strategic Influence: Leverage expertise to develop, implement and maintain supplier quality strategies that align with pharmaceutical industry standards and simplify, standardize and enable scaling of our operations to meet patient demand and company growth goals.  Clearly communicate supplier risks to key stakeholders and leadership.
• Quality Systems Management: Influence and execute the design and maintenance approach to ensure robust quality systems for supplier controls, ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory standards as well as ensuring standard approaches across the networks.  Support periodic management reviews of supplier performance.
• Regulatory Compliance: Stay current with the external environment and evolving industry and regulatory landscape to ensure all supplier activities comply with cGMP and other applicable regulations.  Effectively work with global quality teams that support Lilly quality standards and supplier auditing.
• Continuous Improvement: Transform supplier quality management processes and systems to enhance supplier performance and product quality and gain efficiency in operations globally.  Leverage innovation to proactively identify and mitigate supplier risks.  Identify opportunities to improve technologies, including use of advanced technologies, processes and services to enhance Global Supplier Quality.
• Materials Management: Support the procurement and quality assurance of raw materials, consumables, components and intermediates for the networks ensuring they meet the required specifications and standards for pharmaceutical production.
• Supplier Relationship Management: Build and maintain strong relationships with key/critical suppliers, negotiating Quality Agreement requirements, providing technical leadership in governance of supplier performance, driving proactive improvements in quality, and partnering with suppliers and internal stakeholders to ensure seamless supply chain operations and product quality.
• Inventory Control: Serve as a business partner to network Supply Chain in the management of inventory levels of materials to ensure optimal stock without compromising quality or production timelines.
• Supplier Audits: Provide risk-based input to the annual audit plan based on knowledge of supplier criticality and performance, and participate, as required, in audits, inspections and completion of committed corrective and preventative actions.
• Leadership and People Development: Utilize experience and technical expertise to coach and mentor team members, fostering their professional growth and enhancing overall team performance.  Create a culture of quality and compliance excellence by engaging suppliers and stakeholders, providing recommendations and establishing action plans for continuous improvement.

Basic Requirements:

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

• Minimum of 7 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 in leadership role or role of direct influence, preferably in Quality Assurance

 

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

• Minimum of 5 years of experience in the pharmaceutical or other regulated industry with demonstrated knowledge and application of applicable regulations and related quality systems.
• Minimum of 3 years of leadership role or role of direct influence, preferably in Quality Assurance

 

Demonstrated ability to coach and mentor personnel (inside and outside of function) to achieve cross-functional operational excellence

Strong analytical and complex problem-solving skills with demonstrated ability to assess and manage risk in decision making

Demonstrated ability to effectively interact with and influence outcomes with internal stakeholders and external parties (suppliers/partners, regulators, etc.)

Strong written and verbal communication skills with demonstrated ability to effectively convey messages at all levels of the enterprise

Additional Skills/Preferences:

• Advanced degree preferred
• Proficient in pharmaceutical manufacturing quality management systems and experience as a Quality leader in commercial manufacturing sites.
• Demonstrated ability to lead large-scale projects or programs with significant risk, impact and complexity to achieve critical business objectives.  Success in leading change and/or process simplification; relevant certifications such as Six Sigma will be advantageous.
• Self-motivated and action-oriented with ability to operate effectively and adapt quickly within a global, matrixed organization
• Experience in regulatory agency interactions
• Experience with eQMS systems
• Excellent interpersonal skills, including the ability to remain constructive and civil in difficult or demanding situations.

Additional Information:

• Periodic US and international travel is required (e.g. visits to manufacturing sites and suppliers)
• Primary location is Lilly Corporate Center, Indianapolis, Indiana but consideration can be given for location at existing global Lilly manufacturing site

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$151,500 - $222,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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