Associate/Manager - Commercial QA

1 month ago

Philadelphia, Pennsylvania, United States Eli Lilly and Company Full time

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:

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 methodsCollaborate 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 managementLead/participate in internal or external CMO quality auditsMonitor incoming product complaints, oversee CMO complaint investigations, and ensure timely investigation closureLead and/or support the development and revision of Commercial QA Standard Operating ProceduresSupport the preparation and presentation of Quality Management Reviews, periodic CMO performance quality reviews, and Annual Product ReviewsParticipates 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 qualificationExperienced aseptic process microbiological contamination control strategies and identifying sources of contaminationExperienced in quality oversight of PET radiopharmaceutical manufacturing and large network contract manufacturing organizationsProficient in the execution and reporting of GMP quality audits of aseptic manufacturing facilities, manufacturing processes, laboratories, environmental monitoring, and controlsAble to interpret GMP/ICH regulations to develop site level procedures, and assure the adequacy of CMO procedures and risk-based control strategiesExperienced in contract manufacturing quality oversightKnowledgeable of pharmaceutical analytical chemistry and microbiological test methods and microbiological evaluations of manufacturing environmentsWell versed in root cause analysis deviations and OOS investigations, failure modes analysis tools, risk evaluations, and the writing of standard operating proceduresExperienced in developing site level procedures according to corporate level and current regulatory quality standardsWell versed in QA review of Master or executed Batch Records, SOPs, change control records, process or analytical validation, QA agreementsFamiliar with manufacturing scale up and tech transferAble to effectively communicate in both written and verbal forms to both internal and external customersAble to work independently and collaboratively in a team environmentAble to lead or facilitate team meetings and employ necessary and project management skills for meeting successAble to plan, organize, and prioritize when there are competing projects/activitiesKnowledge 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 requiredLilly 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 statusEli 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

  • Commercial Lines Account Manager

    4 weeks ago

    Philadelphia, Pennsylvania, United States Brandon Insurance Group Full time

    Why You'll Love Working HereBrandon Insurance Group is not just a workplace; it's a company where professionalism, engagement, responsive customer service, a family-oriented atmosphere, and a commitment to work-life balance come together to create an exceptional work environment. Professionalism is at the core of everything we do.What We Are SeekingOur...

  • Inside Sales and Proposal Associate

    4 weeks ago

    Philadelphia, Pennsylvania, United States Angeion Group Full time

    Inside Sales and Proposal Associate – Commercial ServicesOpportunityAngeion Group is looking to welcome a new Inside Sales & Proposal Associate to its rapidly growing team. This position is full-time/remote.About The CompanyAngeion Group is a leading provider of comprehensive settlement management services for class actions, mass tort, and bankruptcy...

  • Associate/Manager – CMC Regulatory

    3 weeks ago

    Philadelphia, Pennsylvania, United States Eli Lilly and Company Full time

    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...

  • Senior Client Solutions Associate

    1 day ago

    Philadelphia, Pennsylvania, United States GLG Full time

    GLG is seeking Senior Associates for our Client Solutions team who have a strong interest in excelling at best-in-class client service in a performance-driven, merit-based, and team-oriented environment.​Our Client Solutions team is the engine driving GLG – the World's Insight Network. Senior Associates work directly with our clients – professionals at...

  • Account Manager

    1 day ago

    Philadelphia, Pennsylvania, United States Michael Page Full time

    About Our Client At the heart of PageGroup's business are the thousands of people's lives we change, the outstanding service we provide to our clients and candidates and the exciting opportunities within our offices all over the world. We're proud to set the standard in the recruitment profession - our specialist service with a personal touch is how we...

  • Senior Project Manager-IT

    2 weeks ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the...

  • Associate Manager, Facilities

    2 weeks ago

    Philadelphia, Pennsylvania, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description Coordinate scheduled and unscheduled work activities while sustaining a safe work environment. Respond to emergency events such as power outages, broken pipes, weather events, etc. Manage moves and renovations as well as various vendors/contractors. Independently manage complex systems and a diverse team of 3-5 technicians to support...

  • Warehouse Associate

    6 hours ago

    Philadelphia, Pennsylvania, United States Impilo Full time

    Hourly Operations AssociateWe are looking for someone that can assist with our daily shipment and warehouse operations. Hours are flexible (office hours are 9am-5pm M-F ) Title: Operations AssociateHours: 40 hours a weekCompensation: $15/hourLocation: In-Office (Bridesburg, Philadelphia) ResponsibilitiesAssisting with the fulfillment of medical device orders...

  • surface maintenance repairer

    1 month ago

    Philadelphia, Pennsylvania, United States Department Of The Army Full time

    Summary THIS IS A NORTH DAKOTA NATIONAL GUARD TITLE 32 EXCEPTED SERVICE POSITION.This ND National Guard position is for a SURFACE MAINTENANCE REPAIRER, Position Description Number D and is part of the ND FMS 6, National Guard. Duties As a Surface Maintenance Repairer, you will perform maintenance, repair, troubleshooting, inspection, diagnosis, and/or...

  • Senior Cell Manufacturing Associate

    4 weeks ago

    Philadelphia, Pennsylvania, United States Proclinical Full time

    Senior Cell Manufacturing Associate - Contract - OnsiteProclinical Staffing is seeking a Senior Cell Manufacturing Associate to join a cutting-edge biotech company. This is a contract role located in Philadelphia, PA.Skills & Requirements:Bachelor's degree or some post-secondary education.3+ years of experience in biopharmaceutical based GMP manufacturing...

  • Corporate Underwriting Associate

    1 week ago

    Philadelphia, Pennsylvania, United States Munich Re Full time

    Corporate Underwriting Associate - Casualty Company Munich Re America Location Philadelphia , United StatesWe are adding to our diverse team of experts and are looking to hire those who are committed to building a culture that enables the creation of innovative solutions for our business units and clients.The Company Munich Re Specialty Insurance (MRSI)...

  • Full-Time HR Associate

    3 weeks ago

    Philadelphia, Pennsylvania, United States My Independence at Home LLC Full time

    Description: My Independence at Home (MYIAH) is looking to fill the position of the Full Time Human Resource Associate. MYIAH provides home care services to the elderly and adults with physical and intellectual developmental disabilities in Bucks, Chester, Delaware, Montgomery, and Philadelphia counties. The role of the Human Resource Associate is to provide...

  • P/T Associate Veterinarian

    2 weeks ago

    Philadelphia, Pennsylvania, United States VCA Animal Hospitals Full time

    VCA Knightswood Animal Hospital is seeking an experienced, P/T Associate Veterinarian to join our AAHA-accredited, small animal practice in Philadelphia, Pennsylvania . We've been serving the local community for more than 50 years Each doctor and staff are dedicated and compassionate providing the best medical care and service to our clients and patients....

  • Associate Medical Director

    1 month ago

    Philadelphia, Pennsylvania, United States gpac Full time

    gpac is excited to partner with an extrodinary opportunity in the Philadelphia, Pennsylvania area This practice is looking for an Associate Medical Director to join their team.This will consist of:75% - Service: provide veterinary care for animals and serve as an Attending Veterinarian in the absence of the AV. The AMD will oversee quality control,...

  • Global Application Investigation Leader

    3 weeks ago

    Philadelphia, Pennsylvania, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    bioMérieux Inc. Global Application Investigation Leader - F/M/NB bioMerieux has a position open for a Global Application Investigation Leader to be based in Philadelphia, USA. Within the Global Industry Customer Service (GiCS), the Global Application Investigation Leader is responsible of Complaint Handling Process. It includes the management, the...

  • Technical Support Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States bioMérieux Full time

    A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution...

  • Merrill Market Supervision Manager

    1 month ago

    Philadelphia, Pennsylvania, United States Bank of America Full time

    Job Description:At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we deliver for our clients, teammates, communities and shareholders every day.One of the keys to driving Responsible Growth is being a great place to work for our...

  • Dietitian/Wellness Manager

    2 weeks ago

    Philadelphia, Pennsylvania, United States Brock and Company Inc. Full time

    Description: Registered Dietitian/Wellness ManagerFull-Time Benefits EligibleHome/Hybrid Office-Based with 40% travel64K - 69KWe are recruiting a full-time registered Dietitian/Wellness Manager to create, coordinate, and deliver nutritional information in our education and corporate facilities for various ages. Our ideal candidate will have a background in...

  • Senior IT Project Manager Application Development

    2 weeks ago

    Philadelphia, Pennsylvania, United States Liberty Personnel Services Full time

    Senior IT Project Manager Application Development ( Remote)My client is looking for a remote long term consultant Senior IT Project Manager with an enterprise software focus.The manager would like to see :5+ years of current PM experience leading multiple projects with budgets over 200kMS project a must including effort-driven project planning techniquesMust...

  • Manager, Enterprise Procurement

    2 weeks ago

    Philadelphia, Pennsylvania, United States NBC Universal Full time

    Company DescriptionWe create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our theme parks and consumer experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, MSNBC, CNBC, NBC Sports, Telemundo, NBC Local Stations, Bravo, USA Network, and...