Manager, Quality Clinical Svc

PCI Pharma Services • Rockford, IL

8h

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. S u m m a ry o f O bj e c t i v e: P la ns , d ire c t s , a n d c oord i n ates Q u ali t y a c t i v ities o f a d esig n a ted C li n ic a l C us t o m er F o c us e d T e a m to e n su r e t h at g o als a n d ob j e c ti v es o f t h e te a m a r e a c c o m p li s h ed w it h in p r esc r i b ed t i m e f r a m es a n d in b u d g et. Select, s u p e r v i s e, e m p o w e r , c o a c h , d e v el o p a n d r etain a te a m o f q u al i f ied i n d i v i d u a l s i n c l u d i n g : Q u al it y S p e c iali s t( s ) a n d Q u ali t y C oord i n at or( s ) w h ile p a r t n e r i n g w i t h t h e Sr. C li n ical P ro j e c t M a n a g er to e n su r e t h at w e d e l i v er a q u ali t y prod u ct, o n t i m e. D r i v e s pro j e c t s u c c ess t h ro u g h a c t i v e lea d e r s h ip to p r o v i d e P C I a c o m p etit i v e a d v a n ta g e i n l on g - te r m q u ali t y c us t o m er m a n a g e m e n t.

Requirements

• B a c h el or 's D e g r ee in a r elat e d f ield a n d / o r 7 - 10 y e ar s r elat e d e x p e r ie n ce a n d / o r trai n i ng .
• Stati s tical a n d A d v a n c e d M a t h e m a tical S k il l s
• A d v a n c ed C o m p u ter S k il l s : A b ili t y to p e r f or m t h e m o s t c o mp lex c o m p u ter ta s k s a n d op e r ate v a r i o u s c o m p u ter pro g r a m s .
• F u ll P ro f e s s i o n al P ro f ici e n c y : A b ili t y to s p e a k , r e ad , a n d w r i te f l u e n tl y a n d a c c u rate l y o n a ll le v e l s p e r ti n e n t to pro f es s i o n al n e ed s .
• Hi g h R e a s o n i n g : A b ili t y to s o l v e pr a c tical prob le m s a n d d e a l w i t h a v a r ie t y o f c o n c r ete v a r i a b les in s it u a ti o n s w h e r e t h e r e is o n l y li m ited s t a n d a rd izati o n . A b ili t y to i n te rpr et a v a r ie t y o f i ns t r u cti o n s t h at m a y b e pro v i d ed in v a r i o u s f o r ms .

Nice To Haves

• P r o j e c t A c c o m p li sh m e n t E x p e r ie n ce

Responsibilities

• Select, su p e rv i s e, e m p o w e r , c o a c h , d e v el o p a n d r etain a team o f q u a l i f ied i n d i v i d u als t h ro u g h e ff e c t i v e e m p l o y ee d e v el o p m e n t, p e r f o r m a n ce m a n a g e m e n t, s u c c e s s i o n p la n n i n g a n d r e c o gn iti o n .
• E n s u r e t h e a ppropr iate team st r u ct u r e is i n p lace b y p e r f o r m i n g w ork l o ad a n a l ys is to m a n a g e h e ad c ou n t a n d to e n s u r e w e d eli v er o n c u s t o m er a n d b us i n ess c o m m i t m e n t s .
• E s ta b li s h q u ali t y te a m a n d i n d i v i d u al g o als a n d ob j e c ti v es in ali g n m e n t w i t h C l i n ical C us t o m er F o c u s ed T e a m g o als a n d c us t o m er r e q u ir e m e n t s .
• E n s u r e s tr on g ali gn m e n t a n d c oord i n ati o n w i th o t h er b us i n e s s u n its a n d f un c ti o n al g ro u p s .
• C o lla bor ate o n b est pr a c tices w i t h o t h er C l i n ical Q u ali t y M a n a g e r s a n d lea d e r sh i p .
• Facilitate t h e d ai l y q u a li t y of te a m p e r f o r m a n ce to e n su r e g o a l s a n d ob j e c ti v es a r e m et a n d t o b u ild a c u lt u r e o f s a f e t y , q u ali t y , p e r f o r m a n c e , c us t o m er s e r v ice a n d c o n t i nu o u s i m pro v e m e n t.
• M a n a g e t h e tra i n i n g a n d d e v e l op m e n t o f t h e te a m i n c l u d i n g c ro s s trai n i n g i n iti a ti v es a n d o n - bo a rd i n g o f n e w e m p l o y e e s to t h e te a m .
• P ro v i d e su ppor t f o r c us t o m er a u d it s , v i s i t s a n d c on f e r e n ce c all s .
• Wor k w i t h C li n ical C us t o m er F o c us ed T e a m to d e v el o p sys t e m ic c orr e c ti v e a c ti o n s to a n y d e v iati o n s n o te d .
• O v e r s ee i nv e s t i g ati on s , c o n s u m er c o m p la i n t s , C A P As, D E A a c t i v iti e s , NMR i s s u es, etc.
• C o lla bor ate w i t h t h e o t h er team m e m b e r s to m a n a g e t h e te a m p e r f o r m a n ce m e trics a n d c u s t o m er s c or e c a rd .
• Collaborate w i t h t h e a ppropr iate A c cou n t E x e cu ti v e a n d Sr. P r o j e c t M a n a g er to c oo r d i n ate a n d f a c ili t a t e t h e c us t o m er Q u a r te r l y B us i n e s s R e v i e w ’ s .
• Provide p r o a c ti v e q u ali t y a s s ur a n ce a n d r i s k a ss e s s m e n t u s i n g FM E A , H C C A P , a n d Q u a l i t y b y Des i g n .
• Adherence to P C I a n d cG M P po licies, pro c ed u r es, r u les a n d r e gu lati o ns .
• Performs o t h er d u ti e s as a s s i g n ed b y M a n a g e r / S u p e r v i s or .

Benefits

• PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager