Operations QA - Associate Director

Eli Lilly - Concord, NC

Full-time - Senior

Concord, NC

Chemical Manufacturing

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 Associate Director (AD) of Operations is responsible for staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start-up, and validation of the parenteral operations (PAR) or device assembly and packaging (DAP) areas. During the project phase, the AD will ensure that the group meets annual production goals and plans through 1-3 year horizons. This role includes direct line supervision of Supervisors and Operations Associates, leading cross-functional process teams, and ensuring consistency of operations across shifts through active engagement on the shop floor. The AD will lead and conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services/Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups. They will also present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions. The AD will maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve. Additionally, they will participate in the development and implementation of strategies focused on Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE).

Responsibilities

• Staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start-up, and validation of parenteral operations or device assembly and packaging areas.
• Ensure the group meets annual production goals and plans through 1-3 year horizons.
• Lead cross-functional process teams and provide direct line supervision for Supervisors and Operations Associates.
• Conduct area deviation and corrective action discussions with cross-functional teams.
• Present operations investigations and procedures to Regulatory Agencies as a Subject Matter Expert (SME).
• Ensure consistency of operations across shifts through active engagement on the shop floor and Gemba walks.
• Maintain and communicate metrics to measure performance against business objectives and implement necessary changes for continuous improvement.
• Participate in the development and implementation of strategies focused on Continuous Improvement, RCA, FMEA, and OSSCE.
• Support Site Leadership to build a diverse and capable site organization while delivering operational procedures, quality processes, and controls for the manufacturing area.
• Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering, and Environmental/Safety.

Requirements

• Bachelor's degree in a STEM or pharmaceutical related field of study.
• At least 7 years working in the pharmaceutical industry, preferably with Parenteral or Device Assembly knowledge.
• Previous management or leadership experience including leading or working effectively with a cross-functional group.
• Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA.
• Excellence in interpersonal, electronic, written, and oral communication.
• Strong technical aptitude and ability to train and mentor others.

Nice-to-haves

• 6+ years in manufacturing/operations with 4+ years in a supervisory role.
• Knowledge of cGMP standards and FDA (or other industry) guidelines for production.
• Experience with highly automated equipment (isolators, device assembly, packaging, etc.).
• Creation of standard operating procedures, work instructions, and training documentation.
• Experience with equipment & facility design documentation reviews.
• Facility, equipment, or system start-up experience.
• Qualification and process validation experience.
• Familiarity with Manufacturing Execution Systems and electronic batch release.
• Experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
• Knowledge of continuous improvement methodologies and mindset (lean, six sigma, etc.).
• Experience with documentation, deviation, and change management systems (e.g., Trackwise, Veeva, QualityDocs, Kneat).

Benefits

• Competitive salary
• Health insurance
• 401k retirement plan
• Paid time off
• Opportunities for professional development
• Employee resource groups for support and networking