Program Manager Resume

SUMMARY:

Business professional with 29 years of medical device industry experience. Quality lead for the Worldwide, US and regional Service teams. Validation Program Manager. Support implementation of corporate initiatives to ensure compliance and improved efficiencies.

PROFESSIONAL EXPERIENCE:

Confidential

Program Manager

Responsibilities:

Unit representative for a project to align US business units for Service Quality.
Project lead for instrument platform document standardization project.
Develop and implement Service data trending metrics using statistical methods.
Lead & participate in risk assessments for Service process changes.
Represent Quality Assurance on cross functional teams to assist in complaint resolution.
Lead & support Service process & system improvement, including global alignment.
Lead corrective and preventive action projects utilizing 8D root cause analysis.
Responsible for Service Quality System implementation and compliance.
Manage and maintain Business Unit Validation Program.

Confidential

Staff Quality Systems Specialist II / Program Manager

Responsibilities:

Led a unit level Quality Manual Standardization Project.
Led the business unit level metrics team that provided a monthly Quality scorecard.
Participated in FDA, ISO and internal audits.
Published quarterly Quality Management Review pre - reads and slides.
Managed one direct report for metrics automation.
Managed and maintained BDDS Unit Validation Program.

Confidential

Principle Engineer / Program Manager

Responsibilities:

Led the business unit BDDS SAP 6.0 Change Management Implementation team.
Distribution Center Quality Systems leader, including representing the business unit on the Worldwide DC Quality Network and the Cold Chain Management Council.
Assisted with successful product transportation domestically and internationally.
Managed and maintained the unit Validation Program.

Confidential

Program Manager, Validation

Responsibilities:

Used or supported the use of Lean and Six Sigma tools in validation activities.
Participated in Management Review, Executive Steering Committees, Quality Leadership Teams, and Champion and Sponsor reviews as required reporting on program status.
Facilitated BD Process Validation Toolkit .
Developed cleaning, analytical test method, & lyophilization validation Quality Policies.
Project lead for a stability gap analysis/mitigation project for all plants.
Partnered with IT to develop and validate an Executive level stability database.
Developed a unit level Quality Policy for Stability.
New Product Development Core Team member, Quality (Design Control)
Co-led a $500K project to implement a Laboratory Monitoring System for the Baltimore Campus to support R&D, Quality and Operations equipment and systems.