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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. E n s u r e s QA oversig h t of QC ac t ivi t ies a n d t h e i n s p ec t i on r e a d i n ess o f t h e si t e.
Re s p o n s i b i l i t i e 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:
QA for QCL

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

St a bil i ty p r ogr a m

• 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.
• E n s u re t h e c o m p li a n c e w i t h s t a b ili t y r e g u la t ory c ommi t m e nt s.
• 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
• E n s u re t h at t h e s ch e d u l e d a u d i t s are p e r f or m ed a cc or d i n g t o th e SOP

• E n s u r e s t h e c o m p l e t ion of c or r ec t ive a c t i o n s s t e mmi n g f r o m t h e a ud i t s

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.
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