Site Compliance Leader
Eli Lilly and Company
3 months ago
On-site
Houston, TX
Clinical Research and Development
Site Compliance Leader
Key Responsibilities
- Ensure processes needed for the Houston quality management system are established and documented.
- Monitor and report on the effectiveness of the quality management system and needed improvements.
- Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Liaise with and influence central groups on corporate quality standards and initiatives.
- Sponsor site initiatives related to quality and compliance; support network initiatives for local implementation; connect global initiatives to 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 and supplier management, incoming controls, complaints, etc.
- Lead and model behaviors foundational to a strong quality culture.
- Coordinate and manage regulatory inspections and lead the site inspection readiness program.
- Liaise with Regulatory for site licenses and declarations, Site Master file, and other regulatory compliance documents.
- Benchmark with external sources to understand industry trends and share with internal quality organizations.
Educational Qualifications and Experience Requirements
- BSc/Hons BSc/MSc/PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
- 12+ years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
Additional Skills & Preferences
- Prioritize tasks effectively; work independently; strong written/verbal communication.
- Effective decision-making; build and maintain relationships with colleagues/stakeholders.
- Proficiency with computer applications; strong problem-solving.
- Experience creating procedures and training materials.
- Mentor and lead others.
- Strong follow-up skills to complete projects on time to required standards.
Additional Skills & Requirements
- Proficient in English.
- Travel: 20%.
- Authorized to work in the United States full-time; Lilly does not sponsor work authorization or visas.
Benefits (as stated)
- Company bonus (FTE employees, depending on performance).
- 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance/death benefits, time off/leave benefits, well-being benefits.
Key Responsibilities
- Ensure processes needed for the Houston quality management system are established and documented.
- Monitor and report on the effectiveness of the quality management system and needed improvements.
- Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Liaise with and influence central groups on corporate quality standards and initiatives.
- Sponsor site initiatives related to quality and compliance; support network initiatives for local implementation; connect global initiatives to 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 and supplier management, incoming controls, complaints, etc.
- Lead and model behaviors foundational to a strong quality culture.
- Coordinate and manage regulatory inspections and lead the site inspection readiness program.
- Liaise with Regulatory for site licenses and declarations, Site Master file, and other regulatory compliance documents.
- Benchmark with external sources to understand industry trends and share with internal quality organizations.
Educational Qualifications and Experience Requirements
- BSc/Hons BSc/MSc/PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
- 12+ years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
Additional Skills & Preferences
- Prioritize tasks effectively; work independently; strong written/verbal communication.
- Effective decision-making; build and maintain relationships with colleagues/stakeholders.
- Proficiency with computer applications; strong problem-solving.
- Experience creating procedures and training materials.
- Mentor and lead others.
- Strong follow-up skills to complete projects on time to required standards.
Additional Skills & Requirements
- Proficient in English.
- Travel: 20%.
- Authorized to work in the United States full-time; Lilly does not sponsor work authorization or visas.
Benefits (as stated)
- Company bonus (FTE employees, depending on performance).
- 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance/death benefits, time off/leave benefits, well-being benefits.