Manager Process Improvement

SENIOR PROGRAM MANAGER

Thrive on complex challenges that address barriers to organizational

success. Enthusiastic, ethical, analytical and creative and proactive

process improvement and organizational change management professional with

10 years of pharmaceutical industry experience and over 10 years of

financial services experience. Expertly utilize graduate school training

in the most current and essential business process improvement tools and

strategies.

Skillfully and simultaneously manage both customer and organizational

needs. Incorporate six sigma and lean methodologies into program and

project management design and execution in order to successfully direct

organizational change.

Professional Strengths:

Project Management Six Sigma Greenbelt

Team Building Training and Coaching

Strategic Planning Needs Assessment

Relationship Management Supply Management and Logistics

Negotiation Problem Solving

Risk Analysis and Reduction Global Regulatory Compliance

Lean Methodology Sourcing and Budgeting Management

Professional background

aerotek scientific LLC, Wayne, PA

6/08 to 4/10

Program Manager: Contracted to Merck, West Point, PA.

Global Clinical Supply Operations Therapeutic Lead and Subject Matter

Expert

Simultaneous management of the non-drug supply budgets of 12 clinical

trials across 4 therapeutic areas.

. Directed 3 teams of therapeutically aligned buyers and supply

planners.

. Clinical Trial Team Award Recipient: 3rd Quarter 2009

. Created and Implemented Lean Six Sigma Process Improvement Projects

o Vendor Standing Order Processes

. Ongoing & Annual Review

o Leased Items Sourcing Process

o Vendor Comparison Cost/Benefit Analysis

. Successfully negotiated 1 year medical device lease extension with no

price increase.

. Moderated global clinical site training sessions and developed

successful trouble shooting guidelines for medical devices

WYETH Collegeville, PA.

7/00 to 6/08

Regulatory Associate: Post Pharmaceutical Drug Approval Strategist in

Chemistry, Manufacturing and Controls (CMC) Division of Global

Regulatory Affairs, Biologics Therapeutic Area

. Strategic Regulatory Lead: Global, Cross-functional, Virtual Full

Scale Manufacturing Site Transfer Team

o Led sub-team addressing unplanned significant chemical component

changes

o Negotiated global documentation requirements with Ex-US contract

manufacturer

. Prevented significant loss of finished drug product by identifying

important component change overlooked by manufacturing site

. Researched and authored global regulatory CMC filing strategies that

became the departmental standard for writing and developing filing

strategies

. Authored quick reference brochure for process improvement initiative

o Cohesive departmental tool for understanding new processes

. Led interim departmental change control process improvement initiative

o Reduced manual data input time and quantity

. Appointed to Global Regulatory Affairs Strategic Excellence Leadership

Team

o Developed and authored leadership team charter.

o Facilitated Intercontinental/CMC sub-team

GE CAPITAL MORTGAGE CORP. Cherry Hill, NJ.

8/98 to 7/99

Senior Underwriter: Credit, financial and real property risk

analysis and assessment. Maximum lending authority: $300,000.

. Received Six Sigma Greenbelt

UPLAND MORTGAGE Co. Bala Cynwyd, PA.

2/97 to 5/98

Senior Underwriter: Credit, financial and real property risk analysis and

assessment.

ADVANTA CORP. Ft. Washington, PA.

1/96 to 2/97

Senior Underwriter: Credit, financial and real property risk analysis

and assessment.

FOUNDERS BANK Bryn Mawr, PA. 3/95 to 1/96

Assistant Retail Services Manager: Supervised and managed branch

customer service and operations and staff of 4 tellers and customer

service representatives.

MERIDIAN MORTGAGE CORP. Wayne, PA.

2/92 to 5/94

Credit and Risk Coach: Trained, developed and guided the underwriting

function of 6 home loan processing teams.

MERIDIAN BANK Philadelphia, PA.

8/88 to 2/92

Assistant Banking Officer/Branch Manager: Managed all operations of

full service retail branch office of 10 employees.

. Increased branch deposits from $10,000,000 to $12,000,000

EDUCATION

Master of Philosophy in Organizational Dynamics - Projects, Programs &

Portfolios: University of Pennsylvania, Philadelphia, PA. 2009. G.P.A.:

3.63.

. Organizational Project Management Certificate

. Organizational Development & Change Certificate

Master of Science in Organizational Dynamics: University of

Pennsylvania, Philadelphia, PA. 2005. G.P.A.: 3.63.

. Organizational Leadership Certificate

Bachelor of Arts in Economics & Sociology: University of Pittsburgh,

Pittsburgh, PA.

Effective Leader and Communicator

Proactive Manager

Advocate for Change

Karen E. Hayes M. Phil., MSOD

*******@***.***

Phone: 610-***-****

____________________________________________________________________

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