Lilly Senior Manager, Commercial Quality Assurance in Philadelphia, Pennsylvania
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.
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.
This position is responsible for the planning, execution, and continuous improvement of Avid’s commercial manufacturing Quality Assurance operations and quality oversight of US contracted PET radiopharmaceutical manufacturing and packaging of starting materials. The position works closely with QA team members, functional area management, commercial manufacturing team members, and contract manufacturing partners to provide and execute quality oversight of contract manufacturing operations according to established procedures and current GMP expectations. In collaboration with QA management, this position identifies annual Commercial QA objectives, strategies, and solutions to achieve these goals and improve local procedures. This position works with R&D Quality, Clinical GMP and Commercial QA, and other functional joint team members to support the readiness contract manufacturing organizations for commercial manufacturing.
Create, revise, and assure the proper risk-based strategy and completeness of manufacturing Quality Agreements
Support the planning, presentation, evaluating and record of periodic CMO quality performance reviews
Provide manufacturing team support for short term strategies and solutions for areas if risk or compliance concerns
Identify and lead efforts to implement improvement opportunities with joint team members and contractor management
Lead efforts to create, revise, and ensure functional area procedures remain current to corporate quality standards, regulatory expectations, and sponsor quality oversight strategies
Lead or support efforts with contract manufacturers to continually strive to reduce risks in manufacturing and efficiencies in workstreams
Assure control strategies of contract manufacturers are aligned with current regulatory expectations and appropriate for the manufacture of aseptically produced parenteral PET Radiopharmaceuticals
Execute internal audits/self-inspections
Support efforts and execute periodic performance reviews of the Avid/Lilly commercial quality system, evaluate quality audit and manufacturing trends for risk and opportunities for improvement
Participate in routine operating mechanisms established for the routine review of commercial manufacturing performance to ensure functional leadership and joint team members are aware of quality performance and issues requiring escalation
Execute on-going inspection readiness and supports regulatory inspections
- Bachelor’s degree in a scientific discipline relevant to drug discovery and development and a minimum 5+ years’ experience in therapeutic pharmaceutical or medical device manufacturing Quality Assurance with at least 3+ years’ relevant to aseptic processing for parenteral products
Strong knowledge of commercial and investigational drug product US and EU GMP regulations (e.g. 21 CFR Part 211, Eudralex Vol 4 GMPs, and applicable guidelines), and able to interpret regulation to develop site level procedures, and assure appropriate procedures are established at Avid and CMOs
Very knowledgeable in pharmaceutical GMP aseptic processing, facility design, environmental monitoring controls, workflows, process and equipment validation and qualification
Proficient in the execution and reporting of GMP quality audits of aseptic manufacturing facilities, manufacturing processes, laboratories, environmental monitoring, and controls
Experienced in contract manufacturing quality oversight and developing risk based appropriate oversight strategies
Very knowledgeable in microbiological test methods and microbiological evaluations of manufacturing environments and/or analytical chemistry lab operations and test methods
Experienced in evaluating and improving risk based pharmaceutical quality management systems
Well versed in root cause analysis deviations and OOS investigations, failure modes analysis tools, risk evaluations, and the writing of standard operating procedures to prevent human error
Able to evaluate and generate practical, compliant, technical risk-based solutions on unique and complex problems
Experienced in writing corporate level quality standards and maintaining current to regulatory standards
Experienced in hosting audits and GMP regulatory inspections
Experienced in staff development, coaching, and identifying learning opportunities
Capable of influencing management, regulators, or external partners on key decisions and improvement opportunities
Demonstrated ability to drive results across multiple functions or large geographical area
Experience leading large-scale projects or programs with significant risk to achieve business objectives
Experience in managing departmental budgets
Familiarity with manufacturing scale up and tech transfer
Evaluation of microbiological organisms and sources of aseptic process contamination
PET Radiopharmaceutical quality control testing
Data integrity controls and Computerized systems validation
Professional pharmaceutical or relevant quality education and skill related certifications
Travel: Approximately 20-35%, majority domestic, as required
Location: Philadelphia, PA
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.
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. If you would like to request an accommodation for medical or religious reasons, you may do so at firstname.lastname@example.org.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!