Janssen Supply Group, LLC is recruiting for a eLIMS Quality Application Owner, NA & LATAM with the preferred location in Titusville, New Jersey, with consideration given to candidate located near a Janssen Supply Group site in Spring House, PA, Horsham, PA, Malvern, PA, Puebla, Mexico, or Gurabo, Puerto Rico! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. The Quality Application Owner eLIMS has to diligently work with the different eLIMS sites, the eLIMS project team & the QC Operations organization to ensure that the business processes and the eLIMS application are aligned, that process harmonization is performed where appropriate, that user requirements are analyzed and challenged versus the lab strategy and, where appropriate, translated into functional requirements of the system, that the system performance is monitored and improved, Additional Post go live support as needed, Ensuring compliance is maintained within eLIMS. RESPONSIBILITIES: Or g a n i z i n g a n d l e a d i n g s i t e ke y us e r m e e t i ng s w i t h t h e o bj e ct i ve t o : • K ee p t h e s i t e ke y u s e r s al i gn e d a n d f u l l y t r a i n e d i n a ll a s p e cts o f t h e s y s t e m • L e ad a n d i n v o l ve s i t e ke y u se r s i n t h e c h a ng e m a n a g e ment d e c i s i o n p r i or i t i z a t i o n , t e st i n g a n d i m p l e men t a t i o n p ro cess • S u pp or t s s y s t e m ro l l o ut s t o n e w s i t e s • U nd er sta n d t h e s i t e s b u s i n e ss n e e d s • I d e nt i fy a re a s f o r i m p r o v e m e nt , e i th e r at t h e s y st e m l e v e l , e i th e r i n t h e bu s i n e ss p r o c e s se s l i n k e d to s y st e m usa g e • E sta b li sh a b e st p r a ct i ce s h a r i n g p ro c e s s a m o n g st t h e d i f f e re n t e L IMS u se r s Ma i nt a in d o cu m e nt a t i o n : • D e v e l o p a n d ma i nt a i n s y s t e m r e l a t e d b u s i n e ss d o cu m e nt a t i o n i n c l u d i n g e v e nt s, i nt ak e s/c l e a r qu e sts • D e v e l o p a n d ma i nt a i n s y s t e m r e l a t e d p r o c e dur e s, ma nu a l s a n d t r a i n i n g m at er i al • D e v e l o p a n d ma i nt a i n i n sp e ct i o n r e a d i n e ss ma t e r i a l • B u i l d s t ro n g par tne r sh i p w i t h ke y u s e r s a n d s t a k e h o l d e r s i n t h e d i f fe ren t s i t e s S u pp or t : • Provide support for the eLIMS Enterprise Lab System across segments within the Johnson & Johnson laboratories following Enterprise Lab systems procedures as well as support and/or ownership of Quality System records/documents using the JSC Quality Systems. • As P ro du ct O w ne r ( o r Qu a l i t y A pp l i ca t i o n O w n e r ) o f t h e c r o s s - sect o r e L IMS p l a t f or m, s uppo r t t h e a ct i v i t i e s d e f i n e d by th e S DLC p r o cess a s a b u s i n e ss re p r e s e nt a t i v e , o r t h e i r d e l e g a t e , th at o w n s th e s o ftw ar e a n d d r i v e s p ro du ct v i s i o n , ro a d m a p a n d o w n s t h e p ro du ct b ack l o g . • S u pp or t d e p l o y m e n t a n d go l i ve p r o cess f o r n e w s i t e s j o i n i n g e L i ms. • P e r f o r m t re nd i n g a n d g e ne r al g o v e r n a n ce o n s y s t e m p e r f or m an c e m e t r i c s , s y s t e m u sa g e a n d da t a c l e a n li n e s s . • I d e nt i fy a re a s f o r i m p r o v e m e n t a n d d r i ve ch ang e , w h e r e n ee d e d . • Act as sp o k e sp e r s o n i n s upp or t t o t h e s i t e s du r i n g r e gu l a t or y i n sp e ct i o n QUALIFICATIONS

• A m i n i m u m o f a B A/ BS d e gr e e ( Sc i e n c e , T e ch n i ca l ) o r e qu i va l e n t i s r e qu i re d
• A m i n i m u m 7 y e a r s o f p ro f e s s i o n al w or k e x p er i en ce i s r e qu i re d
• Knowledge & experience in LIMS (preferably LabVantage) is required
• 5- 10 ye a r s o f b u s i n e ss e x p er i e n ce w i t h i n Q C preferred
• S t ro n g p r o b l e m s o l vi n g a n d a n a l y t i c a l e xp er i e n c e us i n g r i sk -based ap p r o ach a n d a s s e s s m e n t preferred
• G o o d u n de r sta n d i n g o f IT s y st e m s a n d a r ch i t e ct u r e i n c l u d i n g co m put e r s y s t e ms va l i d a t i o n ( 2 1 C F R P a r t II, G A M P) preferred
• P ro j e ct ma n a g e ment s k i l l s preferred
• P r o v e n l e a d e r sh i p a n d i n f l u e n c i n g s ki l l s preferred
• C o m mun i ca t i o n s k i l l s preferred
• C r o s s - fu n ct i o n al e xp e r i e n c e preferred

The anticipated base salary range for this position is $88,000 - $142,025. At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (http://www.careers.jnj.com). #LI-PA1 PRIMARY LOCATION United States-New Jersey-Titusville-1125 Trenton Harbourton Road OTHER LOCATIONS North America-United States-Puerto Rico-Gurabo, United States-Pennsylvania-Malvern, United States-Pennsylvania-Spring House, United States-Pennsylvania-Horsham, Latin America-Mexico-Puebla-Puebla ORGANIZATION JANSSEN SUPPLY GROUP, LLC (6046) JOB FUNCTION Quality REQUISITION ID 2206081498W

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