Associate Director- Quality Assurance

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 Overview

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

The Associate Director – Quality Assurance is responsible for managing the activities of Quality Assurance personnel. The Assoc. Director Quality Assurance must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations.  The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.  The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.

Responsibilities

• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Performance management and development of staff.
• Partner within Quality Assurance and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
• Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio.
• Ensure adequate oversight and technical excellence for investigations and complaints.
• Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality
• Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
• Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.

Basic Qualifications:

• Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.

• 5+ years of experience in Quality Assurance in a pharmaceutical manufacturing environment.

Additional Preferences:

• Responsible for maintaining a safe work environment
• Ability to influence and lead diverse groups
• Influences complex regulatory, business, or technical issues within the site and function
• Experience in statistics
• Technical leadership, administrative and organizational skills
• 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
• 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:

• Minimal travel (<10%) may be required
• Some off-shift work (night/weekend) may be required to support 24/7 operations

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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