Job Description

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 35,000 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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description

This position will provide guidance and direction for day-to-day quality activities ensuring GMP compliance supporting the manufacturing facility*. Examples of day-to-day activities include partnering with the business to resolve critical and/or complex compliance issues, ensuring procedures are aligned with global quality standards and regulatory expectations and are consistent across multiple business areas, assuring data integrity with paper based and electronic processes, oversees implementation of risk-based strategies, leading operational excellence initiatives including productivity and process improvements with significant impact to the quality organization and across the site, ensuring site is inspection ready at all times, interact with FDA and other regulatory/health agencies when necessary. This position represents QA on the Quality Lead Team and other forums for area of responsibility per the Lilly Manufacturing Standards for Operational Excellence. Additionally, this position develops staff, organizational plans, and defines yearly departmental objectives.

Key Objectives/Deliverables

Manage for Results /Strategic Planning:

The following responsibilities apply to Quality Assurance respective to the specific area of oversight:

- Promote a positive quality culture and oversee on-the-floor quality presence in the respective business area (e.g. manufacturing).

- Provide quality direction for complex business and operational issues or technical challenges. Remove barriers as they arise.

- Oversee data integrity for paper based and electronic systems, including quality review of audit trail reviews. Ensure compliance with applicable Lilly global standards and regulatory guidelines (e.g. 21 CFR Part 11 related to computer systems).

- Evaluate and approve change controls, risk assessments, excursions, and deviation investigations. Recommend CAPAs and ensure CAPAs implemented are effective. Ensure that quality system related changes/deviations are evaluated consistently.

- Prepare site for regulatory inspections. Host regulatory and business partner inspections/audits and coordinate inspection/audit responses and commitments.

- Review/approve standard operating procedures, batch records, specifications, validation protocols and reports, instrument acquisitions/decommissions, work orders, as applicable. Ensure processes are harmonized across multiple business areas.

- Serve as key quality resource in lead teams and/or other forums as required and provide compliance guidance to manufacturing and other supporting business units.??

- Collaborate with cross-functional departments during planning and process/continuous improvement projects and initiatives to ensure timely completion (e.g. quality plans objectives and milestones).

- Identify and lead process improvement projects impacting multiple business areas.

- Provide quality oversight for technology transfers or product launches to and from Lilly Branchburg facilities.

- Oversee and monitor Quality metrics. Ensure data compiled is communicated in relevant forums and escalate compliance issues to Quality senior management.

- Mentor, coach, and manage staff performance and development.

- Plan, administer, and monitor the department budget.

Minimum Qualification Requirements:

BA/BS degree in the Chemistry, Biology, or a sciences-related field with a minimum of 5 years technical and/or quality experience in the Biopharmaceutical industry, preferred.

Additional Preferences:

- A minimum of 2 years of management/leadership experience preferred.

- A minimum of 5 years of previous technical and/or quality experience (i.e. production, validation, laboratories) in a GMP regulated environment.

- Requires technical knowledge/understanding of business linkages/drivers outside of own business area, the ability to make decisions guided by policies, and business plans that impact customer service and the work unit’s ability to meet performance objectives.

- Influences internal/external customers and senior management, has the capability to identify and solve a range of organizational and operational problems and technical challenges, able to proactively remove barriers, and influence a positive quality culture.

- Must possess a working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.

- Must have a thorough understanding of data integrity, computer systems validation per CGMPs, and an understanding of System/Software Development Life Cycle concepts.

- Must have experience in leading medium/large scale process improvement projects.

- Must have the ability to function in a fast-paced environment and communicate effectively cross-functionally, with staff, and management (both written and verbal).

- Must be proficient in Microsoft applications and quality systems.

Other Information:

Approximately 10% travel required. Lifting not required.

Required to be on call

*Depending on the role, the specific oversight may include one or more of the following responsibilities – computer systems, manufacturing, laboratory, contract organizations, and facilities, utilities, metrology, and engineering (FUME) - in a multi-product Active Pharmaceutical Ingredient (API) manufacturing facility to ensure compliance with respective industry and regulatory standards.