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.
Educational Qualifications and Experience 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.
Additional Skills & Preferences
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.
Additional Skills & Requirements
Proficient in English.
Travel 20%.
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.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong supp
Benefits
Health insurance
Additional Information
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
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.
Eli Lilly · Houston TX