What are the responsibilities and job description for the Sr. Principal Associate - QA - Global Quality Auditing and Compliance position at Eli Lilly and Company?
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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
96,000 - $162,800
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 Global Supplier Auditor (Supplier Auditor) represents QA-Procurement, which is responsible for the Corporate Supplier Quality Auditing program supporting commercial and clinical manufacturing globally for Lilly human health drug products / devices.
Through auditing, the Supplier Auditor assures that the Supplier or GMP Service Provider has systems and processes in place that are aligned with established standards and are compliant with current regulations and guidelines. The position also assists in determining the appropriate quality oversight and ongoing evaluation needed for each supplier and GMP Service Provider. This position reports to a GQAAC QA-Procurement Associate Director.
The Supplier Auditor also provides support to the site / affiliates by supporting the management of material suppliers and GMP service providers, participating in self-assessment activities and supporting internal / external GQAAC audits / regulatory inspections of the Material / Supplier System.
GQAAC (QA – Procurement) is operating as a valued business partner with manufacturing and procurement and taking a proactive approach to further enhancing the quality status of business operations and regulatory compliance. The Supplier Auditor plays a key part in contributing to the implementation of this strategic approach to supplier quality auditing and the SQM program for Lilly.
Key Objectives / Deliverables :
The following activities will be performed according to established procedures, guidelines, forms and tools. These responsibilities are not intended to be all-inclusive :
- Auditing :
Scheduling, preparing, conducting and reporting local and global supplier audits to assess the level of compliance with established standards and current regulations and guidelines. This includes leading complex audits (“for-cause”, leading audit teams, etc.).
This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.
Contribute to the approval process of a new supplier or GMP service provider.
Assist purchasing, manufacturing and support groups in identifying and managing material suppliers and GMP Service Providers.
Support training to less experienced auditors.
Basic Requirements :
Additional Preferences :
Other Information :
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https : / / careers.lilly.com / us / en / workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
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).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.
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Salary : $96,000 - $162,800
