- Provide sponsor quality oversight of Commercially approved US based PET drug Contract Manufacturing Organizations via QA review and approval of product related GMP documentation including CMO batch disposition records, change controls, specification documents, manufacturing deviations, OOS investigations, Corrective and Preventative actions, qualification and validation of processes and analytical test methods
- Collaborate and support manufacturing projects, technology transfers, CMO GMP performance evaluations, and risk evaluations.
- Lead the sponsor quality review team for CMO deviations, OOS investigations, environmental monitoring investigations and support the related data trend management
- Lead/participate in internal or external CMO quality audits
- Monitor incoming product complaints, oversee CMO complaint investigations, and ensure timely investigation closure
- Lead and/or support the development and revision of Commercial QA Standard Operating Procedures
- Support the preparation and presentation of Quality Management Reviews, periodic CMO performance quality reviews, and Annual Product Reviews
- Participates in/supports regulatory inspections as neededBasic Qualifications:
- Bachelor's degree in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry and a minimum 3+ years' experience in pharmaceutical or medical device manufacturing quality assurance with at least 3+ years' relevant to parenteral product aseptic processing
- Strong knowledge of pharmaceutical drug GMP regulations and applicable guidance documents Additional Skills/Preferences:
- Knowledgeable in pharmaceutical GMP aseptic processing, facility design, environmental monitoring controls, workflows, process and equipment validation and qualification
- Experienced aseptic process microbiological contamination control strategies and identifying sources of contamination
- Experienced in quality oversight of PET radiopharmaceutical manufacturing and large network contract manufacturing organizations
- Proficient in the execution and reporting of GMP quality audits of aseptic manufacturing facilities, manufacturing processes, laboratories, environmental monitoring, and controls
- Able to interpret GMP/ICH regulations to develop site level procedures, and assure the adequacy of CMO procedures and risk-based control strategies
- Experienced in contract manufacturing quality oversight
- Knowledgeable of pharmaceutical analytical chemistry and microbiological test methods and microbiological evaluations of manufacturing environments
- Well versed in root cause analysis deviations and OOS investigations, failure modes analysis tools, risk evaluations, and the writing of standard operating procedures
- Experienced in developing site level procedures according to corporate level and current regulatory quality standards
- Well versed in QA review of Master or executed Batch Records, SOPs, change control records, process or analytical validation, QA agreements
- Familiar with manufacturing scale up and tech transfer
- Able to effectively communicate 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
- Knowledge of GMP regulations/guidance (21 CFR Parts 212, 11 and FDA guidelines for the manufacture of PET drugs radiopharmaceuticals and CGMPs as they pertain to the radiopharmaceuticals industry.Additional Information:
- Lilly currently anticipates that the base salary for this position could range from between $63,000 to $138,600 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.
- Travel: Approximately 20-30%, majority domestic, as required
- 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
- Eli Lilly and Company, Lilly USA, LLC, and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance. Please note, this email address is intended for use only to request a disability accommodation, please email Lilly Recruiting Compliance for further assistance. Inquiries which are not requests for accommodations may not receive a response.
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 ( ) 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.
#WeAreLilly
Associate/Manager - Commercial QA - Philadelphia, United States - Eli Lilly and Company
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 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.
Company Overview:
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.
Position Overview:
The Associate/Manager, Commercial QA serves an integral role within the Lilly-Avid Commercial Quality Assurance function providing drug sponsor quality oversight of PET Radiopharmaceutical Contract Manufacturing Organizations (CMOs), under a New Drug Application (NDA) in the United States. Under the direction of the Senior Director, Quality Assurance, this individual works closely with various functional areas within Quality Assurance, Quality Leadership, Radiopharmaceutical Commercial Manufacturing and external CMO partners to fulfill this responsibility.
Responsibilities: