Project Manager Quality

I am an independent contractor and have just completed a 3 year assignment working as a Sr Validation Consultant on a contract basis for Arbour Group at an East Coast pharmaceutical company. My previous employment was as a Senior IT Project Manager for Abbott Laboratories. Over the past 30+ years, as an accomplished IT professional, I have:

• held various roles with increasing levels of responsibility for Abbott Laboratories.

• established a consulting practice that specializes in IT audit readiness, compliance risk assessment and IT process improvement.

The various positions and experience while working at Abbott and Arbour are highlighted below.

Sr. Validation Consultant

Accomplishments Include:

• QA representative on multiple Validation executions of the Clinicopia, clinical sample management system.

• Provided guidance on the preparation for and successful response to MHRA audit in 2009 that included resolution of previous serious audit findings related to the validation of ARGUS adverse event tracking and safety system.

• Prepared a compliance risk assessment model for use in scaling validation efforts.

• Provided document updates on several critical Quality System SOPs, Work Instructions and Templates.

Sr. Project Manager - Audit Readiness / Continuity Planning

Accomplishments include:

• Project Manager for Change Management Group implementation of Clarity project and portfolio management tool for use in managing ADD Quality and Manufacturing document change control process.

• Managed ADD SOX IT documentation and testing for domestic and international sites according to the COBIT standard were completed on a timely basis.

• Managed ADD IT's Training Plan to ensure that it addresses both compliance and business requirements.

• Managed ADD IT's document system.

ADD I.S. Principal Compliance Analyst.

• Responsible for ADD's IT year 2000 compliance effort. This included establishing the division IT organization’s Y2K methodology, project plan requirements, monitoring to ensure progress, performing site audits, and ensuring that no business impact on ADD as the result of Y2K systems issues.

Sr. Project Manager QA & Strategic Planning

• Provided computer system support for ADD Division Quality and Regulatory functions.

Quality/TPD/R&D Systems Sr. Project Manager

• Department manager for business systems departments providing systems development, operations and support to ADD Reagent Assay Quality, with a total headcount of 17 plus 11 contract personnel and budget of 2.5 million dollars.

ADD Business Systems R&D Systems Sr. Systems Analyst

ADD Business Systems Sales Admin Sr. Systems Analyst

CMIS Project Manager / Sr. Programmer Analyst

Programmer Bankers Life & Casualty

Post Doctoral Research Associate Notre Dame Radiation Lab

EDUCATION

PhD, Inorganic Chemistry, 1976, Oregon State University, Corvallis, OR

B.S., Chemistry, 1970, Carroll College

PROFESSIONAL Training

Project Management training.

References

Available on request.

Contact Information:

Phone: 847-***-****

eMail: ***********@*******.***

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