Sr. Manager - QA Incoming Materials Disposition

Lilly • Concord, NC

101d • $91,500 - $147,400

About The Position

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. The QA Materials Disposition Sr. Manager will report to the Associate Director Quality (Materials). This person is essential to support activities related to the release of incoming materials utilizing SAP.

Requirements

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• 5+ years in leadership with specific QA experience, including leading or working effectively with a cross-functional group.
• Strong knowledge of Quality Management Systems and applicable regulatory requirements.
• Previous batch disposition experience.
• Previous pharmaceutical experience.
• Previous regulatory inspection readiness and inspection execution experience.
• Demonstrated understanding of cGMP practices including good documentation practices, data integrity and regulatory compliance.
• Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
• Strong attention to detail.
• Proficient in computer system applications.
• Ability to organize and prioritize multiple tasks, highly flexible, and able to work independently in fast paced environment to support production demands.
• Excellent interpersonal and networking skills.
• Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others.
• Experience in inventory management systems (SAP, EWM, etc.).

Nice To Haves

• Previous facility or area start up experience.
• Understanding of statistical tools and analysis.
• Previous experience with Deviation and Change Management process.

Responsibilities

• Manage, develop, and provide guidance to the incoming disposition team.
• Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process.
• Manage a team of QA incoming batch disposition associates.
• Ensure team is trained and training remains in compliance.
• Ensure materials not meeting specifications are quarantined, per local procedures.
• Ensure materials are released in a timely manner, as to not delay production.
• Evaluate temperature excursions on shipments received at the warehouse.
• Perform appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.).
• Perform final disposition of incoming materials.
• Initiate complaints/remarks to supplier for materials not meeting Lilly expectations.
• Participate in investigations regarding materials or service complaints.
• Author/revise SOPs, materials specifications, as needed.
• Interact with other quality functions and support material related Supplier Change Notifications.
• Participate in/support regulatory inspections, as needed.
• Communicate with QA Associate Director Materials and other cross functional peers on quality issues.
• Network with the business and ensure all materials are dispositioned in a timely manner to support production schedule.

Benefits

• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree