Central Quality Leader

1 week ago

Concord, North Carolina, United States Lilly Full time

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.

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.

Lilly is building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

The Central QA Manager is responsible for ensuring that operations have a robust quality oversight by developing and maintain quality systems and programs such as Change Control, CAPA, Complaints, Self-inspection, Stability, and Quality SOP and training. Is responsible for the coordination of the activities required as part of regulatory and corporate inspections and for the proper retention of GMP documents. Ensures QA oversight of QC activities and the inspection readiness of the site.

Responsibilities

Lead efforts to establish appropriate quality standards and expectations for Concord Quality System. Influence and advance the site's Quality Culture. Ensure ongoing robustness of the business processes that support key quality system programs (e.g. deviation, change). Plan and conduct inspection readiness activities for the site. Support internal audits and external inspections. Network with Lilly quality organizations, including but not limited to inspection readiness, implementation of compliant quality systems and share best practices.

Manage a team that is responsible for:

QA for QCL

  • Responsible for the oversight of Quality Assurance over the Quality Control area activities.

Stability program

  • Design and Manage the stability program, ensuring that the program components are operational.
  • Ensure the compliance with stability regulatory commitments.
  • Complaints
  • Manages the complaints system
  • Ensures that SOPs are current and that complaints are handled according to corporate requirements.
  • Monitors systems performance

Self-Inspection program

  • Ensures that a Site Master schedule for Self-inspection is generated and approved
  • Ensure that the scheduled audits are performed according to the SOP
  • Ensures the completion of corrective actions stemming from the audits

Deviations and Change Control systems

  • Manages the Change Control and deviation system
  • Ensures the proper functioning of the CAPA team
  • Ensures that SOP are current and in compliance with regulatory and corporate standards
  • Monitors systems performance

Basic Requirements:

A minimum of 5 years of relevant cGMP experience in pharmaceutical manufacturing, quality, technical services or engineering and associated Quality Systems with demonstrated technical proficiency.

Ability to function in a team environment as a leader and as a member of teams.

Ability to effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.

Demonstrated ability to partner/network with other sites.

Demonstrated participation in inspections and inspection readiness activities. - Demonstrated ability to lead change and influence at a site level.

Demonstrated ability to manage projects.

Proficiency with computer systems.

Parenteral Process/facility Knowledge.

Additional Preferences:

Device Related knowledge is preferred.

Other Information:

Travel required.

Required to be on call.

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 ( ) 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.

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