Entry Level Leader

3 weeks ago

Concord NC, United States Lilly Full time

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 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. 
T h e Central QA Manager is r es p o n si b le f or e n s u ri n g t h at o p er a t io n s h ave a r o b u st qu al i t y o v e rsig ht by d evel o ping a n d mai nt ain q u al i t y s y s t e m s a n d p r o grams s u c h as Cha n g e C o nt r o l, CAPA, Com p lai n t s, S e l f - inspection, S t a b ili t y, a n d Quality SOP a n d t rai n i n g. Is r es p o n si b le f or th e c oor d i n a t ion o f th e ac t ivi t ies r e q u ired as p a r t o f r e g u la t ory a n d c o r p o ra t e i n s p e c t io n s a n d f or t h e p r o p er r e t e n t ion o f G M P d o c u m e nt s. 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:
Responsible for the oversight of Quality Assurance over the Quality Control area activities.

Design and M a n age t h e s t a b il i t y p r o gram, e n s u ri n g t h at t h e p r o gram c om p o n e nt s are o p er at i o n al.
Complaints
Manages the complaints system
Ensures that SOPs are current and that complaints are handled according to corporate requirements.
Monitors systems performance
S e l f- Inspection p r ogr a m
E n s u r e s t h at a S i t e M a s t er s c h e du le f o r Se l f - inspection is ge n er a t ed a n d a pp r o v ed
Manages the Change Control and deviation system
Ensures that SOP are current and in compliance with regulatory and corporate standards
Monitors systems performance
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 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 manage projects.
- Proficiency with computer systems.
- Parenteral Process/facility Knowledge.
Travel required.
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. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. 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.

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