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.
Each Lilly employee will embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and the House of Manufacturing and under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.
Position Brand Description: This position will provide guidance and direction for day-to-day quality activities ensuring GMP compliance supporting the downstream purification operations at Lilly Branchburg. 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 while remaining consistent across multiple business areas, assuring data integrity with paper based and electronic processes, overseeing the 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 the site is inspection ready at all times, interacting with FDA and other regulatory/health agencies when necessary. This position represents QA downstream purification on the Quality Lead Team and other forums as per the Lilly Manufacturing Standards for Operational Excellence (MSOE). Additionally, this position guides/develops staff, provides strategic direction for their area of responsibility, creates organizational plans, and defines yearly departmental objectives.
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 trails. 4. 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/reports, instrument acquisitions/decommissions, job plans, work orders, as applicable. Ensure processes are harmonized across multiple business areas.
- Serve as key Quality resource on Lead Teams and/or other forums as required and provide compliance guidance to Manufacturing, QC, FUME 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 Plan 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 are communicated in relevant forums and escalate compliance issues/concerns to Quality senior management.
- Mentor, coach, and manage staff performance and development.
- Plan, administer, and monitor the department budget.
- BA/BS degree in Chemistry, Biology, Computer Science, Engineering, or a science related field, as applicable.
- Requires a minimum of 5 years technical and/or Quality experience (i.e., production, validation) in a GMP regulated environment, Biopharmaceutical industry preferred.
- A minimum of 2 years of management/leadership experience is required.
- A minimum of 1 year of experience supporting protein purification processes or technologies (i.e., laboratory, development large scale).
- 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 Lifecycle 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.
- Approximately 10% travel required.
- Lifting not required.
- Required to be on call.
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.