Site Compliance Leader

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.

Key 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.

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 dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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 support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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