Lilly Sr. Principal Associate-Quality Assurance in Branchburg, New Jersey
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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. 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.
Independently works within the Lilly Branchburg Process Team environment per Manufacturing Standards for Operational Excellence (MSOE), 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. Assists with implementation of quality improvement plans. Provides QA presence in areas of responsibility (GMP laboratories) by conducting periodic walkthroughs. Ensures regulatory compliance and procedural consistency between manufacturing facilities. Prepares cross-functional partners for Regulatory Inspections. Provides assistance during regulatory/partner inspections. Ensures compliance observations associated with Lilly Branchburg Laboratories are adequately addressed and completed on schedule.
Evaluate complex deviations and ensure appropriate root cause/likely assignable cause(s) and assess quality impact. Recommend CAPAs and ensure CAPAs implemented are effective.
Evaluate change controls and associated risk assessments and ensures harmonization across multiple compliance functions. Perform change effectiveness evaluations.
Perform training within group or throughout organization as needed. Write/escalate Notifications to Management.
Ensure timely completion of all quality plan objectives and milestones. Support the on-time performance metric.
Create quality metrics and present to cross-functional management. Utilize metrics and other tools to monitor the state of compliance and implement continuous improvements accordingly. Keep Quality Management informed of compliance status.
Perform periodic walk-throughs of laboratories.
Lead continuous improvement initiatives to Quality programs.
Lead activities associated with technology transfers to and from Lilly Branchburg facilities.
Serve as core member on Process Team(s), a cross functional group charged with making medicine, continuous improvement, and site support.
Serve as key quality liaison between disposition and compliance by supporting lot release through ensuring timeliness resolve of compliance issues.
Mentor less seasoned quality professionals.
Ensure compliance with applicable regulatory guidelines, perform review of regulatory submissions.
Participate in Regulatory and partner inspections as necessary. Ensure timely follow up to any inspection findings.
Review/approve deviations, CAPA, change controls, procedures, protocols, reports etc. as needed.
Partner with cross-functional groups and management with inspection readiness activities and interact with the FDA and other regulatory agencies, as required.
Perform system Audit Trail Reviews to ensure Data Integrity.
BA/BS degree in the sciences with a minimum of 3-5 years' experience in Biopharmaceutical industry.
Strong quality compliance background and previous technical experience in laboratories (Bioassay/Biochemistry preferred).
Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.
Demonstrated ability to work independently.
Must possess depth and/or breadth of expertise within discipline.
Previous technical experience should be in biotechnology manufacturing processes (large scale cell culture, purification processes, validation, facilities).
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%.
Lifting not required.
Required to be on call.
Shift work may apply.
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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).