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Project Delta Communication Package - Dec 7 Final

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Project Delta Communication Package - Dec 7 Final

  1. 1. Project Delta – GPO Quality Assurance Regional Operating Model December 7, 2006
  2. 2. 2 Project Delta – GPO QA Regional Operating Model A competitive advantage is the capacity to reinvent your business model before circumstances force you to. The QA regional model has been developed to: – Manage quality within GPO – Ensure appropriate compliance (local requirements) at a market competitive cost, – Utilize flexible and adaptable Quality systems / processes, and – Foster and recognize talent in a performance based culture
  3. 3. 3 Project Delta – GPO QA Regional Operating Model • Drive transformational change that creates a best-in-class Quality organization capable of competing in a highly cost competitive and dynamic pharmaceutical manufacturing environment. • Goal is to: – Develop a Quality System operating model and organizational structure that is flexible and adaptable to changing business needs while fostering and rewarding strong individual performance. – Ensure the services, talent and accountability are at the optimal level in the organization to drive business value. – Ensure appropriate compliance to local requirements at a market competitive cost.
  4. 4. 4 Project Delta – GPO QA Regional Operating Model • Move from a centralized to a more decentralized (Regional/ Plant) model. • Ensure that truly global business initiatives and strategies are managed by Global Division. • New model best supports our business needs – Within 5 years 88% of PPG’s products will be competing for market share with generic competition – Increasing cost competitiveness among pharmaceutical manufacturers – Growing pressures on healthcare costs – Rising expectations from regulatory agencies – Need for further clarity of roles and responsibilities within GPO QA • New model is similar to those operated by J&J, Novartis and is currently being rolled out by GSK.
  5. 5. 5 Regional Operating Model Region 2 Plant D Plant E Plant F Region 1 Plant A Plant BPlant C Region 3 Plant G Plant H Plant I Global Division
  6. 6. 6 GPO QA Regional Operating Structure PAA LA Global Division U.S./Puerto Rico Abbott Park North Chicago Wyandotte Whippany Barceloneta Jayuya Ludwigshafen Queen- borough Sligo St. Remy Liestal Campo- verde Karachi Goa Katsuyama Cimangis Shanghai Barceloneta Worcester Biologics Mexico Rio de Janeiro Buenos Aires Europe
  7. 7. 7 Project Delta – GPO QA Regional Operating Model The expected benefits from Project Delta are aligned with Abbott’s core values: • Pioneering – Developing sustainable systems that drive compliance and quality by design – Enabling a culture that provides tools and skills that drive innovation – Supporting a strong talent management program to provide leadership for future business needs • Enduring – Adapting proactively to changing business and regulatory needs – Investing in our future (people and financially)
  8. 8. 8 Project Delta – GPO QA Regional Operating Model • Caring – Demonstrating mutual respect with our employees, business partners and the community – Understanding everything we do is for the benefit of our patients • Achieving – Implementing meaningful ideas and improvements that add value for our customers and patients – Creating a simplified business structure leading to clear roles, responsibilities and accountability
  9. 9. 9 Critical Success Factors • Collaborative Leaders at all levels • Change Management • Implementation of Expert Councils • Organizational Transformation
  10. 10. 10 Change Management • A formal change management program is being implemented to facilitate the next steps of the transition to the regional model. The transition includes business processes, culture, talent management, organizational structure, roles, responsibilities and accountability. – First change management session will be scheduled in Lake County in December, 2006. – Change Management sessions will be made available to all regions and will be scheduled during 1st Quarter 2007. • Program will include continuous communication and feedback to the Transition Team
  11. 11. 11 What are Expert Councils? • Functional teams with representation across plants, regions and Strategic QA • Responsible for: – Liaison with CRQS – Policy Development – Quality System Process Improvements – Communication – Benchmarking – Best Practices – Consistency across plants and regions – Evaluation of industry and regulatory trends
  12. 12. 12 Expert Councils – Matrix Organization Plant A Plant B Plant C Region 1 Plant D Plant E Plant F Region 2 Plant G Plant H Plant I Region 3 Plant J Plant K Plant L Region 4 Expert Councils
  13. 13. 13 Expert Councils – Validation – CAPA – Complaints – Quality Engineering – Document Control – Training – Compliance – Microbiology/Environment Monitoring – Lab – Analytical – Lab - Stability – Distribution QA – Commercial QA – TPM QA – Supplier QA
  14. 14. 14 Expert Councils - Benefits •Better Utilization of Resources •Connection between plants/regions •Knowledge Sharing/Benchmarking – Regionally and Worldwide •Decisions and Initiatives at Appropriate Areas and Levels •Continuous Improvement •Development of Employees •Prevention of Quality Issues •Active Engagement by the Organization •Drive Consistency Where Needed Across Regions and Worldwide
  15. 15. 15 Expert Councils – Next Steps • Identify Council members by subject, plant and region end of 2006. • Training for Council members during 1st Quarter 2007.
  16. 16. 16 M a ria n n B r u n k e r A d m in A s s is t R o b e rt O 'H a g a n A B C Q A D ir G r is e ll G o m e z A B L Q A M g r R o lf R a tk e M a n a g e r H u m ir a D P , Q u a lity D a v id N e s s R e g io n a l S e r v ic e s D ir B ill G a n z e r D V P B io lo g ic s R e g io n J o rg e R o c c a ta g lia ta A r g e n tin a Q A D ir J u n ia R o d rig u e s B r a z il Q A D ir F r a n c is c o P e re z M e x ic o Q A D ir J o s e A n to n io M a rt in e z R e g io n a l S e r v ic e s D ir L a u r a O b e n a u f D ir e c t o r L a tin A m e r ic a R e g io n S u n il A c h a r y a In d ia Q A M g r C h u n X ia n g W a n g C h in a Q A M g r F a rr u k h H a fe e z P a k is t a n Q A D ir T r iy a n ti H u n iy a t i In d o n e s ia Q A M g r Y o s h ie T a k a h a s h i J a p a n Q A M g r V in c e n t C h a n g R e g io n a l S e r v ic e s D ir J a v ie r R iv e ra D ir e c to r P A A /J a p a n R e g io n M ig u e l C r e s p o Q A D ire c t o r S y n t h ro id Q u a lity S t e v e R itt e r W y a n d o tt e Q A M g r L e ila F u e n te s J a y u y a Q A D ir R ic k M o s s W h ip p a n y Q A D ir N a n c y L in d s e y A P L Q A D ir B r ia n B r a u n L C Q A D ir N ic o la s M a ld o n a d o R e g io n a l S e rv ic e s D ir J e s u s F e rn a n d e z D V P U S / P R R e g io n S t u a rt S ta m p U K Q A D ir J im O 'R e g a n S lig o Q A D ir P a u l-L o u is G a y re l S t R e m y , Q A D ir C la u d io V e rg a r i C a m p o v e rd e Q A D ir L o rra in e T h o m p s o n L ie s ta l Q A M g r U lr ic h B e c h t L u d w ig s h a fe n Q A D ire c t o r T o d d C h e rm a k D ir e c t o r E U M o d e r n iz a t io n & P r o je c t F o r w a rd Y v o n n e F re n c h R e g io n a l S e rv ic e s D ir R o g e r D r a p e r D V P E u ro p e R e g io n K a th ry n W h ite D ir , C o m p lia n c e & O p e ra tio n s T ra in in g G e n e G r a c e y D ir e c t o r, S tr a te g ic B u s in e s s & P ro j J o d y V o ig h t D ir e c t o r G P O Q A C o m p lia n c e O p e ra tio n s T im S c h u e t te r D ir e c t o r G P O Q u a lity S y s te m s S h irle y K r e u tz fe ld t D ir e c to r Q A S tr a t e g ic In itia tiv e s T im T o m k o v ic h K e n L y o n J a c k ie V e iv ia J o h n M a r g e ts o n P a u la S ta p le s F r a n k L im o n e s M a r ily n F ro n tz D ir e c t o r Q A O rg T r a n s itio n T e a m B o b S te w a rt D V P G P O G lo b a l Q A GPO Global Quality Assurance
  17. 17. 17 R o b e r t O ' H a g a n A B C Q A D ir e c t o r G r is e ll G o m e z A B L Q A M a n a g e r R o lf R a t k e M g r , H u m ir a D P Q u a lity C a r la A lo n g i G lo b a l C h a n g e C o n t r o l D e m e t r a M a c h e r a s G lo b a l C h a n g e C o n t r o l B r ia n H o f f m a n C A P A S p e c ia lis t P a m W a r la n d R e g u la t o r y C o m p lia n c e J o n O g le T P M Q A D a v id N e s s R e g io n a l S e r v ic e s D ir B ill G a n z e r D V P B io lo g ic s R e g io n Biologics Region
  18. 18. 18 J o r g e R o c c a t a g lia ta A r g e n t in a Q A D ir J u n ia R o d r ig u e s B r a z il Q A D ir F ra n c is c o P e r e z M e x ic o Q A D ir Iv a n T o r r e s Q u a lit y E n g in e e r D e a n n e S t a h l M g r , C o m m Q A / D is tr J u s t in S t r a u b Q u a lit y P r o j M g r L y d ia V la is a v lje v ic M g r , T P M S / A u d it J o s e A n t o n io M a r t in e z R e g io n a l S e r v ic e s D ir L a u r a O b e n a u f D ir e c t o r L a t in A m e r ic a R e g io n Latin America Region
  19. 19. 19 S u n il A c h a ry a In d ia Q A M g r C h u n X ia n g W a n g C h in a Q A M g r F a rru k h H a fe ez P a k is ta n Q A D ir T riy a n ti H u n iy a ti In d o n e s ia Q A M g r Y o s h ie T a k a h a s h i J a p a n Q A M g r J o J o M u n ji T P M Q A O m a r R iy a l C o m m e rc ia l Q A /D is trib C h ris T o rk e ls o n Q u a lity E n g in e e r V in c e n t C h a n g R e g io n a l S e rv ic e s D ir J a v ie r R iv e ra D ire c to r P A A /J a p a n R e g io n PAA/Japan Region
  20. 20. 20 M ig u e l C r e s p o Q A D ir e c to r S y n th r o id Q u a lity D a v id H ill C o m p la in c e M g r. B r ia n H in tz Q C L a b M g r. S te v e R itte r W y a n d o tte Q A M a n a g e r E r ic k N ie v e s Q A O p s M g r C a r m e n T o r r e s C o m p lia n c e M g r. E v e ly n S a n c h e z Q C L a b M g r R a m o n ita R o d r ig u e z C o m p lia n c e O ff ic e r Iv a n F lo r e s C o m p lia n c e O ff ic e r L e ila F u e n te s J a y u y a Q A D ir e c to r R a y B a s tia n M fg Q A M g r. F r a n k A d a ir M ic r o b io lo g y M g r. A m y J o h n s o n Q C L a b M g r. S in d y F o s te r T r a in in g & C o m p lia n c e M g r. J a n ie W a lla c e D o c u m e n ta tio n M g r. R ic k M o s s W h ip p a n y Q A D ir e c to r M a ria A . G a r c ia P la n t O p s . Q A M a n a g e r A P L F G O p e r a tio n s P a u l H e ls tr o m P la n t O p s . Q A M a n a g e r A P L A P I O p e r a tio n s Y a n ir a C o lo n A P L Q C L a b M g r C a r m e n M o n ta lv o A P L C o m p lia n c e M g r N a n c y L in d s e y A P L Q A D ir e c to r M a r k K a p p e l P la n t O p s . Q A M a n a g e r A P F G O p e ra tio n s L a rr y M ills P la n t O p s . Q A M a n a g e r N C A P I O p e r a tio n s M ik e B e a u m o u n t L C Q C L a b M g r P a t D e a s o n - B ie d r o n D o c M a n a g e r F G R o b in C o m e in E n v ir o n m e n ta l M g r M a g d a V e g a M a n a g e m e n t R e v ie w A m y S c h u lte C o m p lia n c e Q A M g r N C F G O p e r a tio n s B r ia n B r a u n L a k e C o u n ty Q A D ire c to r M r id u la M e n o n M a n a g e r P D M A C o m p lia n c e N e lly M ilm a n C o m p lia n c e M a n a g e r P h y llis S e d a r S u p p lie r / T P M Q A D ir e c to r J u lie S m ith L a b e l C o n tro l M a n a g e r L a r r y R h o d e s M a n a g e r, S ta b ility S e rv ic e s N ic o la s M a ld o n a d o R e g io n a l S e r v ic e s D ir J e s u s F e r n a n d e z D V P U S / P R R e g io n US / PR Region
  21. 21. 21 J a y M c G u f f in J u lie R u t h e r f o r d L in d a W r o b e l J a im e A b r e g o A n a B u s t o s H e c t o r C le m e n t e M e lis s a G o n g o r a D o n n a W in f r e y N a t h a n H il l L a b e l E d it o r P r o o f r e a d e r S u p L u k e J a c o b s e n M a r t h a L o p e z B e n O n d o M e lb a A y a la ( A I) K o n n ie O s b o r n ( A I ) M ic h a e l F r e e b o r n G r a p h ic s / A I L a b e lin g S u p D in a D o r r C in d y Y e ld o n J u lie S m it h L a b e l C o n t r o l M g r J a c q u e lin e P e t e r s o n R is a B a ld y A n d r e a N o f s in g e r P a t r ic ia W e lle r S a r le y H a ll P a t r ic ia F r a n k lin B r ia n D ie t z D o m in iq u e K e n d r ic k C o m p la in t s S e c t io n M a n a g e r M a r g e D ie t r ic h J e f f H u lb e r t L a r r y M a x w e ll L u is R o s a le s C h ic a g o D C M a n a g e r P h il Z a c h N e lly M ilm a n C o m p lia n c e M a n a g e r J u d y E m m e r t F r a n k W a g n e r D e b b ie W h it s o n J u lie W e b e r T o n i U r ib e G a r y D a n c a M a r ily n G a r b a r in o N ic o le J e a n b la n c K a r e n M a g n u s o n L u is N ie v e s L a u r a J o h n s o n D o n S c h a e f e r M ik e Z ie lk e S t e v e D a lt o n P e d r o R iv e r a T P M C E P H E li C o lo n T P M C E P H B o b B o w m a n G a il P r a t t J im M o g g e d J ill F e ld m a n A n g e la K e lle h e r P h y llis S e d a r S u p p lie r / T P M Q A D ir M a r ia L a F le u r Q A P r o je c t M g r T o m H u s k e C o m p lia n c e A n a ly s t M r id u la M e n o n P D M A C o m p lia n c e M g r C . V ila y c h a c k E v a P ih u e la c D e b b ie E g g e r D a n a A n E r ic W a r d J o h n R iv e ra D o u g N e ls o n M ik e K a p la n J o c e ly n C a d y R ic k O r t iz W a lt e r R o u t h D o n n a S a n t u c c i S h a r o n P ie r c e L a r r y R h o d e s M g r , S t a b ilit y S e r v ic e N ic o la s M a ld o n a d o R e g io n a l S e r v ic e s D ir U S / P R R e g io n L a k e C o u n t y US / PR Regional Services
  22. 22. 22 S tu a rt S ta m p U K Q A D ir J im O 'R e g a n S lig o Q A D ir P a u l-L o u is G a y re l S t R e m y Q A D ir C la u d io V e rg a r i C a m p o v e rd e Q A D ir L o rra in e T h o m p s o n L ie s ta l Q A M g r U lric h B e c h t L u d w ig s h a fe n Q A D ir T o d d C h e rm a k D ire c to r E U M o d e rn iz a tio n & P ro j F o rw a r d T h e re s a J o n e s Q A S e rv ic e s M g r T e s h P a te l C o m m e rc ia l Q A M g r B ria n B a c k T P M E U E m m a M c E v o y T P M E U M a rk u s H u s e T P M E U D a v id N e s s (In te rim ) S u p p lie r/T P M Q A J o s e R a m o n S o la Q A M g r S p a in E ric d e W it Q A M g r B re d a E lin e v a n G e e s t Q A M g r A L O G M a rc h e l M o l Q A M g r - L R P E d H a rrig a n L o g is tic s Q A D ir Y v o n n e F re n c h R e g io n a l S e rv ic e s D ir R o g e r D ra p e r D V P E u ro p e R e g io n Europe Region
  23. 23. 23 T e r i D illo n M a n a g e r T r a in in g D e v e lo p m e n t D iv y a T r iv e d i M a n a g e r T r a in in g D e v e lo p m e n t D a v id R a u s c h e n b e r g M a n a g e r , I s o T r a i n K a th r y n W h it e D ir e c to r C o m p lia n c e & O p e r a t io n s T r a in in g M a r c e ll R e i d M a n a g e r S u p p lie r E x c e lle n c e D a v e D o lg i n M g r . Q u a lif ic a tio n L o r e n z o G u t ie r r e z M g r . V a lid a tio n D a v e U lr ic h S t r a te g ic D is t. Q A P a u l W h it s o n Q u a lit y E n g in e e r ( L ie s t a l ) F e r o z P a r d e s i Q u a lit y E n g in e e r L e s s a B u tle r Q u a lit y E n g in e e r D a v e B o e b e l Q u a lit y E n g in e e r R o g e r R a t h u n d e Q u a lit y E n g in e e r J a n e t A n d r e Q A P r o g r a m M a n a g e r M a r c G r e e n f ie l d Q A P r o g r a m M a n a g e r A n n a L a u r a S a v e ll a Q A P r o g r a m M a n a g e r L o c a t e d - C a m p o v e r d e , Ita l y C a th y L e e Q A P r o g r a m M a n a g e r M a r k S a t t e r Q A P r o g r a m M a n a g e r G e n e G r a c e y D ir e c to r S tr a t e g ic B u s in e s s a n d P r o je c t s G r e g K a s t e r C o m p e n d ia l S e r v ic e s / R e f e r e n c e S t a n d a r d s F r a n k K r a ja c i c R is k A s s e s s m e n t /B S E T S E P a t C a r n e y M g r I n t e r n a l A u d i t G a b r ie la W h ip p l e P r o je c t M g r G a r y N o v a k G P O P o lic y M a n a g e r T im Y o s t C o m p lia n c e M a r g e F r e u n d C A P A L in d a B r u c h e r t R e c o r d R e te n tio n /P r o te c t io n M r g . K e n J o h n s o n P r o g r a m M a n a g e r J o d y V o ig h t D ir e c t o r Q A C o m p lia n c e S e r v ic e s D e b r a B a r t e l I T P la n n in g /S e r v ic e s A m y D a w s o n P r o g r a m M a n a g e r G lo b a l D o c T r a n s f o r m a tio n C a r la R e s c h M a n a g e r Q u a lit y A s s u r a n c e D o c u m e n ta tio n K e it h R ic h t e r G Q M S P r o g r a m M g r A d o n n a P h ilip p V M S P r o g r a m M g r W e n d y D o n Q A C o m p la in t P r o g M g r T im S c h u e tt e r D ir e c to r Q u a lit y S y s te m s S h ir le y K r e u t z fe ld t D ir e c t o r G P O Q A S t r a te g ic In itia tiv e s Strategic QA
  24. 24. 24 Strategic QA - Training K e n J u r a n e k K ir k R o b e r t s o n C h r is S c h r o d e r S a n d r a V illa r r e a l T e r i D illio n M g r . T r a in in g D e v e lo p m e n t L is a M e n d o z a D iv y a T r iv e d M g r . T r a in in g D e v e lo p m e n t M it c h e ll G o ld m a n G e ls o m in a I s e n b e r g D a v id R a u s c h e n b e r g M a n a g e r , I s o T r a i n K a t h y W h it e D ir e c t o r C o m p lia n c e a n d O p e r a t io n s T r a in in g
  25. 25. 25 Strategic QA – Strategic Business and Projects M a r k S a t t e r Q A P r o g r a m M a n a g e r M a r c G r e e n f ie l d Q A P r o g r a m M a n a g e r A n n a L a u r a S a v e ll a Q A P r o g r a m M a n a g e r L o c a t e d - C a m p o v e r d e , I t a l y C a t h y L e e Q A P r o g r a m M a n a g e r J a n e t A n d r e Q A P r o g r a m M a n a g e r P a u l W h it s o n Q u a lit y E n g in e e r ( L ie s t a l ) F e r o z P a r d e s i Q u a lit y E n g in e e r L e s s a B u t le r Q u a lit y E n g in e e r D a v e B o e b e l Q u a lit y E n g in e e r R o g e r R a t h u n d e Q u a lit y E n g in e e r A n n e W a r n k e M a r c e ll R e i d M a n a g e r S u p p lie r E x c e lle n c e K e r i M u ld o o n R o b S w o b o d a W a u n e t k a C la r k D a v e D o lg i n M g r . Q u a lif ic a t io n M a r y Z o r c M ic h e lle H a in e s P e g g y B u s t a m a n t e J ill T a y lo r L o r e n z o G u t ie r r e z M g r . V a lid a t io n C h e r r y l C h o i D a v e U lr ic h S t r a t e g ic D is t . Q A G e n e G r a c e y D ir e c t o r S t r a t e g ic B u s in e s s a n d P r o je c t s
  26. 26. 26 C a r o le B o u n d s K im T h o m a s M a rc e lla P ie r re D e W a y n e H a r m o n N ic o le A lfa ro K a r e n T u g g le S t e v e G r e g o ry B a r b D e W a ld L in d a B r u c h e rt R e c o r d R e t / P r o t e c t io n M g r G r e g M a t h ie u C o m p e n d ia l S M E E d S h a d a C o m p e n d ia l S M E M o n ik a P e lle t ie r M a r g a r it a S a la z e r T h e o K o llie R e f . S t d s W illia m M y in t W e - S in g C h a n g T o d d M a r t in g F a n h o n g Z e n g B r ia n C a o M a y ra A b re n ic a G r e g K a s t e r R e fe r e n c e S t a n d a r d s C o m p e n d ia l M g r R a c h a e l M o o re A p ril H e is le r G a b r ie la W h ip p le P r o je c t M g r J o h n C a p e lli L o u is a G a c e k C o lle e n M c K e n n a G a r y N o v a k P o lic y M a n a g e r W a y n e H e it m a n n M a h a N o u je im e D r a g a n O b r a d o v ic h P a t C a r n e y M g r . In t e r n a l A u d its A r d r e n e Y a n c e y R e g u la t o r y C o m p lia n c e (B S E / T S E ) J e n n ife r S c h n e lle r F r a n k K r a ja c ic R is k A s s e s s m e n t / T S E / B S E T im Y o s t C o m p lia n c e C h e r y l B a r a n o w s k i K a r a S m ith M a r g e F r e u n d C A P A K e n J o h n s o n P r o g r a m M a n a g e r J o d y V o ig h t D ir e c t o r Q A C o m p lia n c e S e rv ic e s Strategic QA – Compliance Services
  27. 27. 27 Strategic QA – Quality Systems L o r ile e A d a m s K e n N e ls o n L y n n S t r ie d A lis o n R o t s c h C o n n ie T o lp p i J im C o c k e r ill L y n n B le s s in g L a u r a A m a y a J a c k B a s e le y (H o n g ) T in a P e n g N in a S t e in S c o t t R a s m u s s e n T e r r i R a c h F r e d T e s t L is a W h it e K e n W e b e r D e b r a B a r t e l M g r . Q u a lit y S y s t e m s IT P la n n in g & S e r v ic e s J u d y C a r ls o n R a y H e r m a n E s s e n c e L in d s a y V ir g in ia P e t ro J o h n B a t e s X M L P r o je c t M g r A n g e la S m ith Q M D P r o je c t M g r K e lly S e r a f in i P r o je c t M g r M a r c ia P e a r s o n R u s s R e d e r Q M D D e p lo y m e n t D e b b ie S c h n id e r Q A P r o je c t M g r A m y D a w s o n P r o g r a m M g r G lo b a l D o c T r a n s W a n d a C o llin s B o b b ie M o r r is In t . D o c S p e c ia lis t D a w n B a r c z a k B ill C o n le y C r a ig S m it h L a r a in e D e la h a n t y J u d ie H o e n ig M a r t y L a w le s s M a r y P e c T h o m a s W h it b e c k B r y n n S c h a n d e r C h a n g e C o n t r o l M g r B r ia n A f r y l J u lit t a C e b r z y n s k i In g e H a m m o n d L iz H e ls t a d S h a n n o n J o h n s o n L o u is e L e w i s T h o m a s M a r k u s J u d y P r e s t a y T a m m y R y m e r M a r c ia V a v r e k B o b b ie G r if f i n A lm a B a ile y D o c u m e n t S u p e r v is o r A l H a r t m a n M g r , Q A D o c C e n t e r C a r la R e s c h M a n a g e r Q u a lit y A s s u r a n c e D o c u m e n t a t io n K e it h R ic h t e r G Q M S P r o g r a m M g r W e n d y D o n C o m p la in t P r o g r a m M g r S h a u n t e a T o lliv e r - D e n t o n A d o n n a P h ilip p V M S P r o g r a m M g r T im S c h u e t t e r D ir e c t o r Q u a lit y S y s t e m s
  28. 28. 28 T im T o m k o v ic h K e n L y o n J a c k ie V e iv ia J o h n M a r g e t s o n P a u la S t a p le s F r a n k L im o n e s M a r ily n F r o n tz D ir e c t o r G P O Q A O r g a n iz a t io n a l T r a n s it io n T e a m QA Organizational Transition Team
  29. 29. 29 Project Delta – GPO QA Regional Operating Model • We will continue to drive transformational change that creates a best-in-class Quality organization capable of competing in a highly cost competitive and dynamic pharmaceutical manufacturing environment. • We will have an organization and culture that prides itself on: – Solid execution – A simplified business model – Efficient business processes (quick, flexible, effective) – Right balance of resources with compliance risks – High performing workforce – Clear accountability

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