Lilly Senior Associate - Supplier Quality Management in Helena, Montana
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.
The Senior Quality Assurance Associate – Supplier Quality Management is responsible for fulfilling the quality oversight of Avid’s suppliers and service providers involved with the manufacture of components, materials, custom materials, starting materials, drug product, warehousing, and logistical services.
This position works closely leading and/or collaborating with multiple functional team members in support of drug product manufacturing, supply chain, quality control, and corporate counterparts toward supplier qualification and maintenance.
Execute quality oversight responsibilities of GMP suppliers and service providers
Provide input for 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 standards
Manage established supplier reporting systems and prepares supplier performance metrics and risk determination
Connect and communicate with suppliers to acquire supply chain and quality information
Collaborate with associated Avid/Lilly team members and external partners for success and problem resolution
Determine the identification and appropriate quality oversight strategy and controls for materials
Qualify and maintain suppliers and service providers
Develop and execute defined responsibilities associated with quality agreements
Coordinate the scheduling of supplier audits with corporate quality team members and serves as an audit team member, as required
Manage and lead efforts for supplier change notifications and complaint/corrective actions
Lead the Manufacturing Materials Review Board for supplier performance
Other duties as assigned
- Bachelor’s degree in a discipline relevant to drug discovery, development, and/or commercial pharmaceutical products or a minimum of 3 years of pharmaceutical quality or supplier quality management experience
Working knowledge of applicable regulations, such as global GMP/GLP/GCP regulations: US, EU, Japan and the ability to interpret and apply them
Experience writing and revising Quality Agreements
Experience in risk evaluations and risk management
Ability to work independently and escalate issues, when necessary
SOP writing and QA review
Ability to facilitate meetings with multi-functional team members and management
Quality oversight experience with third party/contract manufacturing
Proficient in root causes analysis, QA review and approval of Deviations/Investigations, quality assessment of CAPA Plans, Manufacturing Batch Records, change control review
Scale up, process validation, and active pharmaceutical manufacturing and regulatory guidelines
Knowledge of effective supplier quality management tracking systems
Demonstrated influencing skills
Demonstrated oral, written, and interpersonal communication, and project management skills
Knowledge of PET radiopharmaceutical manufacturing/GMP
Strong verbal and written communication skills
Ability to simplify complex processes/problems and propose alternate solutions
Ability to think creatively
Ability to travel domestically and internationally <30%
Lilly currently anticipates that the base salary for this position could range from between $58,000 to $113,500 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.
As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company
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 email@example.com.
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!