Sr. Associate-QA Compliance

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.

Organization Overview:

The QA Compliance (QAC) organization is responsible for assuring quality and GMP compliance for commercial and clinical products manufactured by Lilly Branchburg. QAC ensures that the local quality system is implemented and maintained in alignment with Lilly Corporate Quality Standards. QAC champions continuous improvement and technology advancements for the quality systems while ensuring the site is in a state of inspection readiness at all times.

Responsibilities:

• The QA Compliance Professional is responsible for driving Operational Excellence at the site as it relates to key quality processes. 
• This position will partner with Quality and Site Leadership (Quality Lead Team, Flow Team, Process Teams, etc.) to drive initiatives that will result in increased capability, employee engagement, improved business results and outcomes, and ultimately, a stronger quality culture.
• This position will be the site process owner for key quality processes (e.g. deviation, change), provide consultation to site resources responsible for executing these quality processes, and facilitate key governance forums in support of these quality processes (e.g. QLT, DRB). 
• This position is also responsible for analyzing quality data to help identify opportunities for improvement and presenting these analyses at the appropriate avenue/forum (e.g.  Quality Metrics at Quality Lead Team and other relevant process/flow teams).
• This position will partner with cross-functional groups and management with inspection readiness activities and provide assistance during regulatory agency/partner inspections including direct interaction, as required.

Key Objectives/Deliverables:

• Serve as the site process owner for key quality processes.  Provide consultation on these processes to ensure the consistent and compliant execution of these processes.
• Lead large scale quality projects or initiatives with varying levels of complexity for the site.
• Interface, as appropriate, with corporate groups and other sites to ensure alignment across the quality network.
• Establish, analyze, and report quality metrics for Process, Flow and Quality Lead Teams and support the on-time performance metric. Utilize metrics and other tools to monitor the state of compliance and recommend/implement improvements accordingly.
• Lead and manage the revisions to site quality compliance programs, as required.
• Develop and conduct quality systems training for the site (e.g. change management, deviation management, TrackWise, etc.)
• Facilitate key quality forums such as Quality Lead Team, Deviation Review Board (manage agenda, minutes, and follow-up actions)
• Author/Investigate/Evaluate/Review/Approve deviations, changes, documents, as required.
• Ensure timely completion of all quality plan objectives and milestones.
• Prepare site for regulatory and partner inspections.  Interact with regulatory agencies as required.

Basic Requirements:

• BA/BS degree in the sciences with a minimum of 3-5 years experience in the Biopharmaceutical industry.

Additional Skills:

• Demonstrated ability to work independently.
• Must possess depth and/or breadth of expertise within discipline and have strong presentation skills.
• Previous technical experience should be in biotechnology manufacturing and/or laboratory processes
• 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, cross-functional environment and communicate effectively with management and employees.

Additional Information:

• Travel 5%
• Not required to be on call
• Position located in Branchburg, NJ

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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