Site Compliance Leader

About the role

The Site Compliance Leader plays a critical role in managing compliance to all regulatory requirements in line with Lilly Houston procedures, policies and guidelines for next generation biotech facilities. You will work closely with cross-functional teams by having oversight of central quality systems and processes. Provide quality and technical expertise within the quality department of Lilly Houston.

Responsibilities

• Ensure that 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.
• Sponsors site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation; acts as connection for global initiatives related to quality and compliance for local implementation.
• Ensure creation and manage Site Quality Plan and Site Quality Manual and ensure adequate governance of key quality processes at the site (e.g., site quality lead team, management reviews of quality systems, etc.).
• Provide direction for the site-wide quality governance boards (e.g., site quality lead team, deviation review board, change control review board, etc.).
• Ensure adequate quality oversight for material and supplier management, incoming controls, complaints, etc.
• Lead and model behaviors foundational to strong quality culture.
• Cook up and manage Site Inspection Readiness Program.
• Acts as liaison with Regulatory for Site Licenses and declarations, Site Master file, and other Regulatory Compliance related documents.
• Benchmark with external sources to understand industry trends and share with internal quality organizations.

Requirements

• BSc, Hons BSc, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
• Minimum of 12+ years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
• Proficient in English.
• Travel 20%.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.