Lilly Quality Lead, Drug Product External Manufacturing in Indianapolis, Indiana
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.
Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, Central and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.
The QA Lead for Contractor Manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to Lilly GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing and/or packaging product. The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre-Approval/ General inspections by various agencies. The QA Lead is integral for launching new products, packages, processes, and CM's.
The QA Lead is responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.
Lead/ provide support to launch new products/ packages/ CMs
Provide guidance and quality oversight of manufacturing issues, deviations, change controls and CAPAs
Participate on Joint Process Teams
Originate and investigate deviations
Work with Lilly support groups to resolve product related issues
Participate in the creation and revision of standard operating procedures
Participate on Six Sigma Projects to help improve productivity
Provide support on site or remotely during inspections
Author and track compliance to the CM Quality Agreements and CM Quality Plans
Routinely have face-to-face communications with CMs
Track and monitor Quality metrics for trends at the CM
Support Qualifications/ Validation document creation and reviews
Provide and coordinate designated sections for Annual Reports and Annual Product Reviews
Execute SOP assessments of CMs and track completion of outstanding issues
Support CMs effort to maintain and improve their quality systems
Support CMs effort to maintain and improve their quality systems
Provide technical leadership and project management oversight to drive improvements to CM quality systems
Build and maintain strong working relationships with CM key personnel
Benchmark with other Lilly sites to share best practices and drive improvements to CM oversight
Network with external partners and resources to share and learn best practices and trends within the industry
Influence development and revision of local and global quality systems
Act as a mentor and coach to develop the next generation of quality technical leaders
Represent Lilly in external industry forums
Complete other duties as assigned
At least 5 years previous parenteral product manufacturing and/or quality experience
Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experience
Proven ability to work independently or as part of a Team to problem solve
Experience with Lilly electronic systems (SAP, Trackwise, Regulus)
Project management skills
Coaching and mentoring skills
Six Sigma Certification (Green Belt or Black Belt)
Technical understanding of cGMPs and the Global Quality Standards
Knowledge of Pharmaceutical Manufacturing Operations
Strong written and verbal communication skills
Teamwork and interpersonal skills exhibited across functional areas
Ability to organize, prioritize, multi-task, and influence diverse groups
Strong decision making and problem-solving skills
Shift is days, but off-hours may be necessary to support operations
Travel is possible, up to 30%
This position is an onsite position that will require the employee to be onsite the majority of the time. This is not a remote position
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 ( LillyRecruitingCompliance@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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).