Lilly Quality Manager, Global Investigation Product Manufacturing 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.
Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare. For more information, visit www.avidrp.com .
The Quality Manager, Global Investigational Product Manufacturing serves as an integral role within Avid Quality Assurance executing site level QA responsibilities, providing sponsor quality oversight of contract manufactured investigational drug product, and for continuously improving associated Quality Assurance systems, procedures, and controls.
To achieve these objectives, this individual works closely with other functional QA team members, Avid CMC Development, Analytical Development & Quality Control, Technical Operations, Supply Chain, and external contract manufacturing organizations. This position serves as the primary QA representative, in collaboration with internal and external partners, for fulfilling these duties.
Providing QA guidance and consultation for the review of applicable corporate policies, local procedures, quality plans, quality manuals, business processes and workflows to ensure the investigational product GMP quality system and QA responsibilities are aligned with regulations, guidelines and applicable Lilly Standards and best practices
Assuring the performance of GMP quality systems by providing independent verification through internal (self) audits, performance reviews, and ensuring the resolution of quality related issues
Supporting GMP issue escalation to ensure specified events and significant quality related issues are escalated to appropriate levels of Quality management in a timely manner
Managing quality oversight responsibilities to ensure the quality and adequate GMP controls for the manufacture of investigational drug product, precursor, reference standard, and technology transfer projects
Supporting GMP operations in making decisions associated with deviations/OOSs/CAPA and leads QA responsibilities for critical to patient safety and/or product quality
Developing, improving, and executing the GMP external audit program support contract manufacturer qualification and routine oversight
Develop, maintain, and execute Quality Agreements
Providing input and support for periodic investigational product GMP performance reviews
Providing QA review/approval of GMP records such as change controls, technical protocols and reports, analytical validation protocols, process validation records, test methods, specifications, and manufacturing procedures,
Ensuring investigational product complaints are properly managed and investigated
Supporting internal corporate audits and regulatory agency inspections
Other duties as assigned
Basic Qualifications :
- Bachelor’s degree, preferably in a science discipline relative to drug development or the manufacture and/testing of pharmaceuticals and a minimum of 5 years of Quality Assurance oversight of pharmaceutical or medical device manufacturing or equivalent experience in a highly regulated GMP environment, or 10+ years experience in pharmaceutical manufacturing related to Quality Assurance and analytical testing.
Ability to interpret FDA/EU/ICH drug manufacturing regulations and guidelines and apply them toward job responsibilities
Ability to write and/or provide quality assurance technical review of GMP deviations, OOS investigations, and product complaints to ensure an adequate root cause analysis and CAPA recommendations
Well versed in QA review of Master or executed Batch Records, SOPs, change control records, process or analytical validation protocols and reports, QA agreements, and audit reports
Experienced and demonstrated ability to effectively audit aseptically produced drug product manufacturing processes and related quality systems
Experienced in drug manufacturing quality oversight and/or quality control, analytical, and microbiological testing
Experienced in, or quality assurance oversight of, technology transfer, scale up to commercialization
Familiarity with USP guidelines
Experienced working within GMP document management and electronic based tracking systems
Strong knowledge of MS Excel (with formula and macro functionality) preferred
Proficient in MS Office
Experienced in regulatory inspections
Able to communicate effectively in both written and verbal forms to both internal and external customers
Able to work independently and collaboratively in a team environment
Able to lead or facilitate team meetings and employ necessary and project management skills for meeting success
Able to plan, organize, and prioritize when there are competing projects/activities
Able to simplify and resolve complex processes/problems and propose alternate solutions
Able to identify and manage risks to project timelines
Able to assess Quality System related procedures for their effectiveness and make improvements, as necessary
Travel: Ability to travel domestically and internationally up to 25-30%
Location: Remote or Flexible, based on location
Lilly currently anticipates that the base salary for this position could range from between $58,000 to $113,00 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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.
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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).