Sr Associate, QA Compliance
- Eli Lilly and Company
- Branchburg, New Jersey
- Start date
- Mar 29, 2023
- Quality, Quality Assurance, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Best Places to Work
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.
Each Lilly employee will embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.
Position Brand Description:
Independently works within the Lilly Branchburg environment per Manufacturing Standards for Operational Excellence (MSOE) within area of responsibility, resolves key technical/quality problems and drives solutions that impact the site. Leads large-scale projects or programs with high risk and/or complexity. Provides assistance to cross-functional groups and/or management with troubleshooting investigations and problem resolution. Ensure implementation of quality improvement plans. Ensure regulatory compliance and procedural consistency between specific facilities. Prepare cross-functional partners for Regulatory Inspections. Interact with the FDA and other regulatory agencies. Ensure compliance observations associated with Lilly Branchburg Facilities are adequately addressed and completed on schedule.
As applicable, this position is responsible for partnering with the Quality Leader and Quality Leadership staff to lead quality culture initiatives with high visibility and/or complexity resulting in increased capability, employee engagement, and improved business results and outcomes. This individual is responsible for developing strategies, benchmarking with other sites and corporate, and providing leadership for quality related projects, Quality Metrics analysis and presentation at Quality Lead Team and other relevant process/flow teams. This individual can be the site process owner for quality compliance processes (e.g. Quality Plan, product complaints, APR, notification to management etc.).
Manage for Results /Strategic Planning:
Own Quality Plan and/or Activity Plan Quality Management System processes. Ensure timely completion of all quality plan objectives and milestones. Support the on-time performance metric. Plan and participate in health authority and partner inspections, including virtual, as necessary. Ensure timely follow up to any inspection findings. Write/escalate Notifications to Management as applicable. Create quality metrics and present to cross-functional management as applicable. Utilize metrics and other tools to monitor the state of compliance and implement continuous improvements accordingly. Keep Quality Mgt informed of compliance status. Mentor less seasoned quality professionals. Ensure compliance with Lilly global quality standards. Participate in Quality Culture initiatives. Review/approve procedures, protocols, reports etc. as needed. Partner with cross-functional groups and management with inspection readiness activities and will interact with the FDA and other regulatory agencies, as required.
BA/BS degree in the sciences with a minimum of 5-7 years experience in the Biopharmaceutical industry.
Demonstrated ability to work independently. Must possess depth and/or breadth of expertise within discipline. Must possess thorough knowledge of domestic and international GMP regulations and other policies/regulations as applicable. Possesses a conceptual understanding of all Quality functions and business areas. Must have the ability to function in a fast-paced environment and communicate effectively with management. Must be able to work in a cross-functional environment. Must be proficient in Microsoft applications.
Travel required, approximately 10%.
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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.
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 (subject to applicable law).
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