Sr. Director - Program Commissioning and Qualification - Global Facilities Delivery

Eli Lilly and Company; Indianapolis (IN); On-site; USD 147,000 - 216,000; Full time

Job summary

An established industry player is seeking a Sr. Director for Program Commissioning and Qualification within their Global Facilities Delivery team. This pivotal role involves leading commissioning and qualification activities for a major greenfield site, ensuring compliance with regulatory standards and delivering high-quality programs. The successful candidate will collaborate with engineering and operational teams, manage large-scale projects, and contribute to building a culture of excellence in GMP manufacturing. This is an exciting opportunity to influence the future of pharmaceutical manufacturing and make a significant impact on global health.

Qualifications

• 15+ years of experience in C&Q activities within pharma or biotech industries.
• Strong knowledge of ASTM E2500 and verification methodologies.

Responsibilities

• Develop and lead safety programs during project C&Q.
• Manage development and execution of C&Q strategies, schedules, and budgets.
• Provide technical oversight to ensure compliance with industry standards.

Skills

C&Q Activities

Project Management

Regulatory Compliance

Leadership

Communication Skills

Education

Bachelor's degree in Engineering

Bachelor's degree in Science

Bachelor's degree in Project Management

Job description

Sr. Director - Program Commissioning and Qualification - Global Facilities Delivery

Join to apply for the Sr. Director - Program Commissioning and Qualification - Global Facilities Delivery role at Eli Lilly and Company.

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 worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We are committed to our work and prioritize people. We seek individuals dedicated to improving lives globally.

Lilly is constructing an advanced manufacturing facility for API production in Lebanon, IN. This greenfield site is Lilly’s largest investment in manufacturing capacity, supporting current and future products. This role offers a unique opportunity to be part of the startup leadership team, helping to build the organization, the facility, and the culture for successful GMP manufacturing operations.

Job Summary:

The Sr. Director of Program Commissioning and Qualification will lead C&Q activities for major greenfield site capital projects within the Global Facilities Delivery team. Responsibilities include ensuring systems and equipment meet regulatory and business standards, working closely with project managers, engineering teams, and operational readiness teams to deliver high-quality C&Q programs.

Key Responsibilities:

1. Develop and lead safety programs from procedures to field execution during project C&Q.
2. Create and implement comprehensive C&Q strategies for large capital projects, including parallel commissioning of multiple facilities in a GMP environment.
3. Manage development and execution of C&Q strategies, schedules, and budgets to ensure timely, cost-effective delivery.
4. Provide technical oversight to the C&Q team, ensuring compliance with industry standards.
5. Coordinate with project teams to oversee engineering and construction services implementation.
6. Ensure all commissioning packages are approved per trace matrices.
7. Maintain traceability matrices demonstrating testing met user requirements.
8. Build and support a C&Q organization aligned with project schedules and budgets, collaborating with Process Equipment COE and other providers.
9. Monitor market conditions to inform project decisions with current data.

Qualifications:

• Bachelor's degree in Engineering, Science, Project Management, or related field.
• At least 15 years of experience in C&Q activities within pharma or biotech industries.

Preferred Qualifications:

• Proven experience managing large-scale C&Q programs from design to closeout.
• Strong knowledge of ASTM E2500 and verification methodologies.
• Excellent leadership, communication, and organizational skills.
• Experience with greenfield projects and pharma safety processes.
• Knowledge of regulatory standards for C&Q.
• Project management certification (PMP) is a plus.

Work Environment:

• Regular collaboration with project managers, engineering, and QA teams.

Lilly is dedicated to inclusivity and offers accommodation requests for applicants with disabilities. We are an EEO employer, valuing diversity across all protected categories. Our employee resource groups support a diverse workforce. Compensation depends on experience, education, and location, with an anticipated salary range of $147,000 - $215,600, plus potential bonuses and benefits.