Associate Director - Site Quality & Compliance QA for QC

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.

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

The Site Quality & Compliance Organization assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Manufacturing’s central quality processes.

The Associate Director for Site Quality & Compliance is responsible for leading the activities of Quality personnel supporting central quality processes which may include a combination of quality oversight for laboratories, stability, materials, data stewardship, complaints, regulatory interactions, inspection readiness, and quality system ownership.

This specific position focus is QA for QC.

Responsibilities

Team and Personnel Development

Responsible for maintaining a safe work environment, leading safety initiatives, and working safely, and accountable for supporting all HSE Corporate and Site GoalsParticipate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports, recruit new talent and grow team capabilities.Provide Feedback and Coaching to employeesDevelop individuals and team to ensure continuous professional developmentDevelop, lead, and support the site Safety, Quality, and Compliance initiatives and cultureScope of team may comprise of exempt and non-exempt employees.

Leadership

Support the site business plan and influence agenda to ensure reliable supply of quality medicine, strong quality culture and maintenance of cGMP compliance and inspection readinessActively assist in governance instances across the site based on assigned areas of focusServe as a conduit for site, network, and corporate communicationsInteract and engage with other areas in the siteBenchmark and network with other Lilly sites and Global Quality for communications and shared learning (best practices, takeaways, etc.).

Quality And Compliance Oversight

Exhibit critical business decision taking into consideration quality, compliance, and business aspects, raise critical quality issues, when appropriate, in a timely manner and proposing decisions into the escalation forumsSupport Site Quality Plan and lead continuous improvement compliance initiativesEnsure inspection readiness across the site focusing on areas of responsibilityAssist and lead others in support of regulatory inspectionsProvide guidance to significant investigations and compliance gaps across the siteApprove (or reject) technical and quality documents that per local procedures requiring quality M2 level approval such as moderate deviations, changes, complaints, etc.Ensure adequate quality oversight within their areas of responsibilityAct as primary back-up for other Associate Directors in Site Quality and Compliance, upon delegation of authority, the Sr. Director - Site Quality & Compliance.

Basic Qualifications

Bachelors Degree required. Prefer degree in scientific or technical field: chemistry, biology, microbiology, pharmacy, engineering, or equivalent scientific / technical degree.10+ years' experience preferredStrong influencing, interpersonal, and teamwork skills. Excellent communication skillsStrong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environmentDemonstrated experience in a regulated manufacturing environmentProficiency with computer systems including Microsoft Office productsDemonstrate strong oral and written communication and interpersonal skillsExperience with being a mentor, coach and / or giving and receiving feedback.

Additional Preferences

Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirementsExperience in Production, QC, QA, Technical Services, Engineering, or RegulatoryExperience in pharmaceutical industryDemonstrated successful leadership experiencePrevious experience performing with Lilly Quality Systems (deviations, analytical investigations, change, and / or complaints).

Other Information

Overtime may be requiredMay be required to respond to site compliance and business needs outside of core business hours and daysApplicant will be exposed to various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this positionSome OUS and US travel may be required.

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.

#WeAreLilly