Manager, Quality Clinical Svc

About the role

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. Ess e nti a l Duties a nd R e s p o n s ib i liti e s : T o p e r f or m t h i s j o b su c c e s s f u l l y , a n i n d i v i d u al m u s t b e a b le to p e r f or m e a ch es s e n tial d u t y s a t i s f a c t or i l y . T h e es s e n tial d u ties a n d r es po n s i b ili t ies i n cl u d e t h e f o ll o w i n g b u t o t h er d u ties m a y b e as s i gn e d . 1 . 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 . 2 . 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 . 3 . 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 . 4 . 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 . 5 . Facilitate t h e d ai l y q u a li t y te a m p e r f o r m a n ce to e n s u 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. 6 . 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 e s 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 . 7 . 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 . 8 . 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. 9 . 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 . 10 . C o lla bor ate 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 . 11 . P ro v i d e 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 . 12 . A d h e r e n ce 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 . 13 . T h is po s ition m a y r e q u ire o v e r t i m e a n d / o r w e e k e n d w o r k . 14 . K n o w le d g e o f a n d a d h e r e n ce t o all P C I , cG M P, a n d G C P p o licies, pro c ed u r es, r u les. 15 . A tt e n d a n ce to w or k i s an e s s e n tial f u n cti o n o f t h is po s iti o n 16 . P e r f or m s 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 . Q u a lific at i o n s : T h e r e q u ir e m e n ts l i s ted b el o w a r e r e pr ese n t ati v e o f t h e k n o w le d g e, s k i l l, a n d / o r a b ili t y r e q u ired f o r t h e s tated po s itio n . R e a s o n a b l e a c c o mm od ati on s m a y b e m a d e to e n a b le i n d i v i d u a l s w i t h d i s a b ili t ies to p e r f o r m t h e es s e n ti