Associate Director - Quality Assurance - API EM

Associate Director Quality Assurance (QA) API External Manufacturing

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 39,000 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. #WeAreLilly

Responsibilities

The Associate Director Quality Assurance (QA) API External Manufacturing is responsible for managing the activities of QA personnel supporting the oversight of externally manufactured small molecule (SM) APIs and Intermediates. The Assoc. Director QA must balance coaching the QA staff, prioritization and staffing for routine production support activities, implementation of Quality projects, technology transfers, and commercialization. The API EM QA Associate Director is responsible for quality projects supporting API EM, the productivity and development of the QA employees, and the quality of the API EM SM portfolio of products manufactured by the Contract Manufacturers (CM). The API EM QA Associate Director ensures the quality systems of the CM meet cGMPs and are compliant with Quality Agreement(s). The Associate Director will oversee the department's performance, resolution of quality issues, and overarching compliance. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate / industry standards for product commercialization and commercial production. The role requires the ability to work cross-functionally within the site, network, commercialization teams, and multiple global suppliers to deliver on business plan and quality objectives.

Responsibilities include :

• Making decisions regarding the quality of batches, resolution of quality issues and quality performance for partners.
• Leading the API EM QA team, providing coaching / feedback to develop QA employees, including performance management, talent assessments, mentoring, succession planning, and organizational planning.
• Building working relationships with API EM management, key internal customers / partners, and strengthening CM alliances.
• Establishing and improving business processes to provide any necessary interface between the CM's and Lilly's quality systems.
• Supporting API EM's efforts to maintain and improve our quality systems and ensure alignment with Lilly Global Quality Standards and regulatory agency expectations.
• Coordinating quality activities for outsourcing of Lilly's targeted projects to CMs, including maintaining and improving compliant oversight practices.
• Supporting regulatory agency inspections at the CM, providing management status updates and participating in the resolution of regulatory findings by coordinating CM and Lilly responses.
• Ensuring adequate oversight and excellence for investigations and complaints.
• Networking globally to share best practices, rationale, and strategies to ensure harmonization and alignment between sites.

Basic Qualifications

Bachelor's Degree in scientific disciplines of Chemistry, Biology, Biotechnology, Pharmacy, Engineering or other related field. 8+ years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines : TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs.

Additional Skills / Preferences

Responsible for maintaining a safe work environment. Proven leadership, administrative and organizational skills. In-depth knowledge of cGMPs and regulatory expectations. Ability to influence and lead diverse groups. Influences complex regulatory, business, or technical issues within the site and function. High attention to detail and a commitment to quality and compliance. Builds relationships with internal and external customers and partners. Proficiency in delivering highly complex tasks and / or tasks that are highly cross-functional. Demonstrated Project Management skills and ability to coordinate complex projects. Strong analytical and quantitative problem-solving skills, with a proactive approach for identifying and addressing challenges. Ability to communicate and influence effectively across functional groups and stakeholders. Strategic thinking and ability to balance short term needs with long term business evolution. Enthusiasm for changes, team spirit and flexibility. Demonstrated ability to learn & apply technical / scientific knowledge.

Additional Information

10 20% travel may be required. Some off-shift work (night / weekend) may be required to support 24 / 7 operations across global supplier network. This role is based onsite in Indianapolis, IN and is not approved for remote work.

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 for further assistance.

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.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $198,000. 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.