Site Compliance Leader

Lilly • Houston, TX

1d • $123,000 - $180,400 • Onsite

About The Position

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.

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.
• 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 and 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.

Nice To Haves

• Demonstrated capability to effectively prioritize tasks and responsibilities
• Ability to work independently
• Excellent communication skills, both written and verbal, allowing for clear and concise expression of ideas, instructions, and feedback.
• Effective decision-making
• Exceptional ability to build and maintain positive relationships with colleagues, clients, and stakeholders
• Fundamental knowledge of computer applications
• Strong problem-solving skills
• Experienced in creating clear and comprehensive procedures and training materials
• Proven ability to mentor and lead others, providing guidance, support, and motivation to help them achieve their goals.
• Strong follow-up skills, ensuring that tasks and projects are completed on time and to the required standard. This involves tracking progress, addressing any issues that arise, and maintaining clear and consistent communication with all relevant parties.

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.
• Coordinate and manage regulatory inspections and lead the 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior