Project Manager Resumes in ---------: Katherine

Project Manager Resume

Contact Candidate

Name:

Katherine

Location:

---------

Experience:

10+ yrs

Willing to Relocate:

Yes

Willing to Travel:

Yes

Most Recent Job Title:

Project Manager

Personal Website:

https://sites.google.com/site/kfedresume/

Objective:

With significant experience in the pharmaceutical and medical device industry, I am seeking a senior management position to effectively utilize my proficient skills in program and project management, problem-solving, process improvements and staff development.

Resume Text:

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/> B.A. Biology

AREAS OF EXPERTISE

-Program/project management
-Six Sigma green belt
-Quality Systems Regulations
-Staff management/development -Budget/timeline management -Facilitation/mediation
-Process/productivity optimization -Policy development
-Contract negotiations
-Operations management -Product lifecycle management
-Risk management
-FDA Liaison -Corrective action planning
-Technical writing

CAREER SYNOPSIS

KFEDER CONSULTING 2006-present

Independent consulting services focusing on program and project management, organizational development and continuous improvements.

BAXTER HEALTHCARE, Round Lake, IL 2007-2008

Project Manager, Medication Delivery Compliance
* Ensured operations achieved and sustained compliance to Quality System Regulations and corporate standards by providing leadership, expertise and motivational influence to improve efficiencies of critical design projects. Identified and prioritized business and compliance risks and drove to resolution.
* Reduced the corporation's regulatory exposure by leading the efforts with global teams to improve and standardize business unit procedures and processes and develop integrated Quality System sustainability strategies and corrective action plans. As a result, the corporation averted paying further regulatory fines.
* Prioritized and coordinated audit activities related to FDA-imposed Consent Decree including planning and staffing third-party and internal corporate audits.
* Six sigma lead facilitator for product complaint investigations. The investigations were successfully completed, corrective action plans implemented and audit observation responses submitted to FDA in advance of regulatory timelines.

ABBOTT LABORATORIES, Abbott Park, IL 1990 to 2005
Leading global manufacturer of healthcare products

Global Operations Program Manager, Global Pharmaceuticals R&D (2004 - 2005)
* Established program vision, short and long-term goals ranging from policy and procedural changes,expenditures and capital allocations, while managing stakeholder and sponsor communications.
* Developed strategic initiatives and tactical oversight and implemented innovative, sustainable process improvements to ensure global business operations units ran efficiently. This new infrastructure aligned the domestic and international business units into a single, unified global department.
* Managed $40M functional and clinical project budgets. Reduced budget by 17% while significantly improving operations within the first year.
* Ensured achievement of strategic objectives through development of marketing strategies for new products.
* Managed entire pharmacoeconomics' project portfolio including timeline, budget, contract
negotiations and staffing. Organized and facilitated the projects' cross-functional team meetings and ensured project deliverables were on-track to completion.
* Coordinated and facilitated senior management project portfolio management reviews to assess pipeline delivery issues and appropriate course corrections.

Senior Quality Project Manager, Quality Systems Initiative (2002 - 2004)
* Directed and executed several corporate-critical assignments enabling continuous
right-to-manufacture and ensure product availability for on-market products.
* Led a management team that developed an effective and sustainable corporate strategy that ensured FDA compliance while improving product availability. The strategy fostered a 25% reduction in
product backorders and 40% reduction in open CAPA (Corrective Action Preventive Action).
Received "Operations Award of Excellence" for results achieved.
* Accelerated productivity and achieved significant cost savings (reduced headcount) by developing a methodology to reduce cycle time for package insert approval process from eight weeks to seven days. Due to accomplishments, received the Divisional Vice President's award for "outstanding contribution by an individual."
* Generated revenue by identifying opportunities to resolve broad range of issues for over 200 products, including productivity, recall and supply chain.

Senior Project Manager, Technical Product Development (2000 - 2002)
* Achieved targeted goals to correct GMP issues by developing and implementing solutions for substantial compliance resulting in the prevention of further product recall as it related to the manufacturing process.
* Streamlined validation time for proprietary device by 50% by developing an innovative process and eliminating uncovered instrument design flaws that had contributed to product recalls. As a result, new corporate standards were established.
* Led cross-divisional effort to achieve corporate compliance to federal regulations. Developed and implemented a global process to retire legacy systems. This effort led to a $1.4M cost savings for the corporation.
* Developed and implemented manufacturing process improvements. Created training program on new processes for manufacturing technicians.
* Revised divisional SDLC program to industry standards. Trained software engineers on updated processes.

Senior Business Systems Analyst, Logistics Operations (1999 - 2000)
* Project Lead for development, implementation and support of a multi-divisional, global logistics system. The system was implemented one month ahead of project schedule.
* Reduced risk of downtime in high-throughput environment preventing potential revenue loss by resolving serious vendor delivery problems and increasing user involvement to successfully install systems software.
* Authored user requirements, functional and system design specifications.

Software Systems Engineer, Diagnostics Division Laboratory Systems (1998 - 1999)
Quality Engineer, Diagnostics Division Laboratory Systems (1996 - 1998)
Business Systems Analyst, Pharmaceutical Products Division (1994 - 1996)
Information Analyst, Research Computing and Information Science (1992 - 1994)
Research Technician, Diagnostics Division, Reagent Development (1990 - 1992)

CERTIFICATIONS
-Six Sigma Green Belt
-Quality Systems Regulations/cGMP (AAMI)
-Fraud and Abuse in the Pharmaceutical Industry
-Risk Management for Medical Devices (HACCP)

TRAINING
-Project Management Professional Development
-Medical Device Product Development Process
-Pharmaceutical Drug Development
-ASQ Certified Quality Engineer

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