Associate Director - Analytical Quality Assurance – Lilly Medicine Foundry

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.

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Associate Director - Analytical Quality Assurance ensures that laboratory activities conducted in the Lilly Medicine Foundry and with external partners are carried out in accordance with global and site quality standards and/or are following current Good Manufacturing Practice (cGMP). This role leads the team responsible for assuring the laboratory maintains a state of control with regards to the generation, reporting, and maintenance of analytical data.

As the Foundry is currently in design and construction, this position will provide Quality oversight for the detailed design and quality processes related to quality control testing and analytical development. The position is responsible for ensuring that the quality management system is established and adhered to for this area. This position is responsible for monitoring capacity and allocating Quality representatives to provide sufficient support and the project schedule remains on track.

Responsibilities

• Lead a team of people which includes coaching/feedback for performance and development of QA employees as well as recruiting new talent.
• Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness.
• Translate global quality standards, cGMP, and regulatory requirements into site-level procedures.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicating and managing internal and external stakeholders.
• Proactively managing issues, proposing, and implementing plans to resolve as needed.
• Provide quality oversight in Analytical testing, namely: molecule support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of quality documentation (e.g., deviations, change records).
• Ensure that appropriate quality systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards.
• When necessary, evaluate potential impact of incidents on quality of materials, or the integrity of data.
• Coach/mentor others regarding investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation.
• Network with Lilly quality organizations in the implementation of quality laboratory systems and share best practices.
• Promote a positive quality culture and oversee quality presence in the respective laboratory areas.
   

Basic Requirements:

• Bachelor’s degree in Chemistry, or related field with a minimum of 5 years in laboratories and analytical testing and/or quality experience in the pharmaceutical industry, preferred.
• Relevant industry experience in highly paced working environments. Relevant experience of working on large-scale capital project deliveries is highly desirable.
• Strong knowledge of the current GMP expectations and application of quality management systems in execution.
• Previous management experience with responsibilities including performance evaluations and personnel development.

Additional Preferences:

• Ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.

• Ability to input and influence decision making for complex technical issues.
• Ability to influence across multiple functional areas and/or external partners.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Experience with networking across industry, such as w