Site Compliance Leader
Eli Lilly and Company
June 25, 2026
On-site
Houston, TX
Operations
The Site Compliance Leader manages compliance with all regulatory requirements aligned with Lilly Houston procedures, policies, and guidelines for next-generation biotech facilities. Provides quality and technical expertise within the quality department and oversees central quality systems and processes.
Key Responsibilities
- Ensure Houston quality management system processes are established and documented.
- Monitor and report quality management system effectiveness and required improvements.
- Ensure awareness of applicable regulatory and quality management system requirements.
- Liaise with and influence central groups on corporate quality standards and initiatives.
- Sponsor site initiatives for quality and compliance; support network initiatives for local implementation; connect global initiatives for local implementation.
- Create and manage the Site Quality Plan and Site Quality Manual; ensure governance of key quality processes (e.g., site quality lead team, management reviews).
- Provide direction for site-wide quality governance boards (e.g., deviation review board, change control review board).
- Ensure quality oversight for material/supplier management, incoming controls, complaints, etc.
- Lead and model behaviors foundational to a strong quality culture.
- Coordinate and manage regulatory inspections and lead inspection readiness.
- Liaise with Regulatory for site licenses/declarations, Site Master File, and other regulatory compliance documents.
- Benchmark external industry trends and share insights internally.
Educational Qualifications and Experience
- BSc/Hons BSc/MSc/PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
- 12+ years’ quality assurance experience in biotechnology or pharmaceutical manufacturing.
Skills/Preferences
- Prioritization, independence, strong written/verbal communication, decision-making, relationship building, computer proficiency, problem-solving, experience creating procedures/training, mentoring/leadership, strong follow-up.
Requirements
- Proficient English; travel ~20%.
- Authorized to work in the United States full-time (no visa sponsorship).
Benefits (as stated)
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (EAP, fitness, clubs/activities).
Key Responsibilities
- Ensure Houston quality management system processes are established and documented.
- Monitor and report quality management system effectiveness and required improvements.
- Ensure awareness of applicable regulatory and quality management system requirements.
- Liaise with and influence central groups on corporate quality standards and initiatives.
- Sponsor site initiatives for quality and compliance; support network initiatives for local implementation; connect global initiatives for local implementation.
- Create and manage the Site Quality Plan and Site Quality Manual; ensure governance of key quality processes (e.g., site quality lead team, management reviews).
- Provide direction for site-wide quality governance boards (e.g., deviation review board, change control review board).
- Ensure quality oversight for material/supplier management, incoming controls, complaints, etc.
- Lead and model behaviors foundational to a strong quality culture.
- Coordinate and manage regulatory inspections and lead inspection readiness.
- Liaise with Regulatory for site licenses/declarations, Site Master File, and other regulatory compliance documents.
- Benchmark external industry trends and share insights internally.
Educational Qualifications and Experience
- BSc/Hons BSc/MSc/PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
- 12+ years’ quality assurance experience in biotechnology or pharmaceutical manufacturing.
Skills/Preferences
- Prioritization, independence, strong written/verbal communication, decision-making, relationship building, computer proficiency, problem-solving, experience creating procedures/training, mentoring/leadership, strong follow-up.
Requirements
- Proficient English; travel ~20%.
- Authorized to work in the United States full-time (no visa sponsorship).
Benefits (as stated)
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (EAP, fitness, clubs/activities).