Associate Director, Parenteral Operations - Visual Inspection
Location: Concord, North Carolina, United States
Category: Manufacturing/Quality
Job Type: Full-Time, Regular
Job ID: R-81309
Company Overview:
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines and giving back to communities through philanthropy and volunteerism. With over 140 years of legacy and 35,000 employees worldwide, Lilly strives for excellence, integrity, and respect for people.
Position Overview:
Lilly is investing over $1 billion to develop a state-of-the-art, highly automated campus in Concord, North Carolina. This facility will include warehousing, logistics, parenteral operations, medical device assembly, packaging, and QC laboratories.
The Associate Director (AD), Operations will lead and manage the operations group supporting asset delivery, process development, operational readiness, start-up, and validation for parenteral operations, including formulation, aseptic isolator barrier filling, and visual inspection. The role requires domestic and international travel during the project phase and ensures that the team meets production goals after the facility becomes operational.
Key Responsibilities:
Integrity:
Lead with a "Safety First, Quality Always" mindset, encouraging a culture where employees exercise "Stop Work Authority" when necessary.
Guide deviation and corrective action discussions with cross-functional teams.
Act as a Subject Matter Expert (SME) during regulatory inspections and facility tours.
Excellence:
Ensure consistency of operations across shifts through Gemba walks and Practice vs. Procedure evaluations.
Track and communicate performance metrics to continuously improve processes.
Drive initiatives such as Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
Influence and maintain the manufacturing control strategy.
Respect for People:
Build a diverse, capable organization and deliver operational procedures for parenteral manufacturing.
Supervise a team of 40–70 employees across multiple shifts, including supervisors and associates.
Develop objectives aligned with Business Plan goals in production, finances, safety, and quality.
Collaborate with other departments such as Production Planning, HR, Quality Assurance, and Engineering.
Requirements:
Education & Experience:
Bachelor's degree in a STEM or pharmaceutical-related field.
Minimum 7 years of experience in the pharmaceutical industry.
Previous leadership experience managing cross-functional teams.
Strong knowledge of regulatory agency requirements (FDA, EMEA, OSHA, etc.).
Skills & Capabilities:
Strong interpersonal, written, and oral communication skills.
Technical aptitude with the ability to mentor and train others.
Ability to work 8 hours per day (Monday–Friday) with overtime as needed.
Willingness to travel domestically and internationally (up to 20%).
Preferred Qualifications:
6+ years of manufacturing/operations experience with 4+ years in a supervisory role.
Knowledge of cGMP standards and regulatory guidelines.
Experience in aseptic filling, isolator technology, and automated/semi-automated visual inspection.
Familiarity with automated equipment (filling, packaging, etc.).
Experience in continuous improvement methodologies (Lean, Six Sigma).
Proficiency in documentation systems like Trackwise, Veeva, and QualityDocs.
Additional Information:
Frequent business travel may be required.
Must be able to wear required safety equipment.
Lilly offers a comprehensive benefits program, including a company-sponsored 401(k), pension, medical, dental, vision, and vacation benefits.
Lilly is an Equal Opportunity Employer (EEO) and encourages individuals with disabilities to apply.
#WeAreLilly
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