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Associate Director, Supplier Quality Management

4 months 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.

The Associate Director, Supplier Quality Management, Avid leads quality oversight of a global supplier program supporting the manufacture of PET drug radiopharmaceuticals. The individual is responsible for fulfilling the quality oversight and management of suppliers and service providers involved with the manufacture of components, materials, custom materials, starting materials, warehousing, and logistical services.

The position works closely and collaborates with Supply Chain, Global Investigational Product and Commercial Quality Assurance, CMC functional teams and Contract Manufacturers to ensure qualification and management of suppliers and service providers providing both custom and off the shelf materials utilized in the manufacture of PET drug product. This role establishes and maintains standard operating procedures in alignment with corporate quality standards and current GMP expectations. In collaboration with QA management, this position provides strategies, and solutions to achieve these responsibilities, improve the local quality system, and identify workstream efficiencies.

Key Objectives/Deliverables:

Leads the identification, qualification and quality oversight of GMP suppliers and service providersDesigns and contributes to the design of the risk-based supplier quality management program and leads efforts for periodic review and updates of established procedures in alignment with Lilly quality standardsManages established supplier reporting systems and prepares supplier performance metrics and risk determination in alignment with Lilly global standardsConnects and communicates with suppliers to acquire supply chain and quality informationCollaborates with associated Avid/Lilly team members and external contract manufacturing partners to ensure supplier problem resolutionDevelops content and ensures execution and maintenance of supplier quality agreementsCoordinates the scheduling of supplier audits with corporate quality team members and serves as an audit team member, as requiredLeads management and evaluation program for supplier change notifications and complaint/corrective actionsAccountable for the Manufacturing Materials Review Board for supplier performanceSupports and contributes to drug product annual product reviewsManages review and release of packaged intermediate and reference standard materialsEducates and mentors team members on quality requirements and supplier management

Basic Requirements:Bachelor's degree or advanced degree (i.e., Masters, PhD ), in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry and a minimum 10+ years' experience in pharmaceutical or medical device manufacturing Quality Assurance with at least 3 of the years' relevant to parenteral product production and/or device manufacturing

Additional Skills/Preferences:Strong knowledge of commercial and investigational drug product supplier quality managementThorough knowledge of applicable regulations, such as global GMP regulations: US, EU, Japan, ICH Q7 along with IPEC and ISO standards and the ability to interpret and apply them.Experience writing and revising Quality AgreementsExperience in leading risk evaluations and risk managementProficient in root causes analysis, review and approval of deviations/investigations, quality assessment of CAPA Plans and change controlsAbility to simplify complex processes/problems and propose alternate solutionsQuality oversight experience with third party/contract manufacturingDemonstrated negotiation and influence skillsDemonstrated written, and interpersonal communication, and project management skillsKnowledge of PET radiopharmaceutical manufacturing GMP'sAble to communicate effectively in both written and verbal forms to both internal and external customers
Additional Information:Ability to travel domestically and internationally from 10-25%, as requiredPreferred location Indianapolis or Philadelphia and remote will be consideredLilly currently anticipates that the base salary for this position could range from between $122,250 to $179,300 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 ( ) 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