Project Management

CLAUDE HATFIELD

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

Westborough, MA 01581 508-***-****

EXECUTIVE SUMMARY

20+ YEARS OF EXPERTISE IN PROFESSIONAL SERVICES & QUALITY DELIVERED TO THE LIFE SCIENCES INFORMATICS/LIMS MARKET

Broad background and skill set that draws on a rare and valuable mix of business, management, professional services, sales, compliance, and scientific experiences. Leverage uncommonly strong domain expertise to project a consummate sense of credibility and authority that has had an immeasurably positive impact on business development and growth. Key areas of expertise include:

Professional Services Management

Project Management Office

Global Project Management

GxP Compliance

Computer System Validation (CSV)

Software Quality Assurance (SQA)

Quality Management Systems (QMS)

Process Design & Improvement

Release Management

Agile Methodologies

Bring deep strategic thought and an entrepreneurial spirit to every endeavor, contributing to proven track record building and leading successful and innovative high-tech companies.

Collaborated in the vision, product development, and market launch of a pioneering software suite for compliance and productivity improvement that changed pharmaceutical laboratory operations in fundamental ways.

Co-founded and built a pharmaceutical software and services company.

Skillfully translate business and technical requirements into a streamlined and pragmatic approach that gets the job done whether that is the design and implementation of a new product, enterprise-level implementation of paradigm-shifting innovative technology, leadership of multidisciplinary teams, or building customer confidence.

PROFESSIONAL HIGHLIGHTS

SmartSense by Digi Boston, MA

Head of GxP Quality and Validation (2023 – Present)

Project managed all validation projects including interacting with the customer’s quality and validation teams to set expectations and define scope and approach

Provide leadership and direction to the Business Units and Quality teams on GxP compliance

Developed a comprehensive gap analysis of all processes, Standard Operating Procedures and Work Instructions across the organization to identify areas of improvement needed

Worked with the Software Quality team to improve processes and documentation practices

Provided recommendations to the Software Development and Hardware Engineering teams to enhance Quality Management System Standard Operating Procedures and Work Instructions

Created an entire System Validation offering for our pharmaceutical customers that included processes and a complete documentation library to support validation activities

Trained a team in the GxP compliant execution and documentation of validation test cases

Lead all GxP quality audits conducted by our pharmaceutical customers

Sapio Sciences Fort Lauderdale, FL

Vice President Professional Services and Quality (2022 – 2023)

Provided leadership to the Professional Services and Quality teams

Manage the entire project/product implementation lifecycle from scoping, project management, system deployment, system validation

Project managed complex projects and projects for critical customers

Drive operational excellence with reporting on key success metrics

Implement processes to manage and monitor resource allocation, capacity planning and measure resource utilization

Built a scalable, cost-effective professional services organization.

Leveraged extensive compliance background to form a QA team and develop a robust QMS and Computer System Validation (CSV) services offering

Ensure projects are delivered on time, within budget, and of high quality

Achieve project revenue and profit targets

LabVantage Solutions Somerset, NJ

SENIOR PROGRAM / PROJECT MANAGER, LIFE SCIENCES (2017 – 2022)

Project managed a portfolio of projects in the Life Sciences vertical, including multi-site engagements

Ensure projects are delivered on time, within budget, and of high quality

Achieve project revenue and profit targets

Deliver customer engagements that lead to successful client outcomes and high customer satisfaction

Development and maintenance of project plan/timeline and resource plan for all activities

Manage scope and change control including facilitating change order procedures as needed

Manage project issues, concerns, schedules of deliveries and completion estimates

Ensure successful sign-off on project acceptance and turnover to support

Accelrys, Inc. (now Biovia, a division of Dessault Systems) San Diego, CA

SENIOR DIRECTOR, PROFESSIONAL SERVICES (2012-2016)

Tasked with leadership to ensure the smooth transition and integration of VelQuest professional services and processes into the Accelrys Professional Services organization. Efficiently blended the merging teams and processes. Key areas included:

Assumed lead project management role for complex, multi-site projects

Provided leadership to the Professional Services team

Managed the entire project/product implementation lifecycle

Defined, priced, and set expectations for customer projects

Provided compliance expertise and helped define CSV strategies

Selected Results:

PROCESS IMPROVEMENT: Increased productivity by creating standardized processes to guide project implementation while allowing customization to meet unique customer requirements.

COMPLIANCE: Initiated and led modifications to the Accelrys QMS to adhere to more stringent GxP requirements on the commercial side of the pharmaceutical industry.

CHANGE MANAGEMENT: Drove positive organizational changes and achieve buy-in within the merging organizations to make necessary process modifications.

VelQuest Corporation (acquired by Accelrys in Jan 2012) Hopkinton, MA

SVP PROFESSIONAL SERVICES / CHIEF COMPLIANCE AND QUALITY OFFICER / CO-FOUNDER (1999 – 2012)

As a key member of the executive team that founded a groundbreaking start-up firm and grew it into the national leader in paperless lab execution systems for the pharmaceutical market, and was instrumental in all business-critical activities including:

Strategic Planning & Budget Management

Executive-level Business Development & Customer Relations

Quality Management System

Release Planning and Management

Product Development

Professional Services Management

Customer Support

Selected Results:

SOLUTION DEVELOPMET: Identified unmet market needs and developed a software suite to improve pharmaceutical laboratory productivity and compliance and replace inefficient, error-prone, paper-based processes with automated solutions that seamlessly integrated with existing IT systems.

PROFESSIONAL SERVICES: Built a scalable, cost-effective professional services organization. Built the team, defined and created processes and tool sets. Assumed the lead project management role for complex, multi-site projects.

PRODUCTIVITY IMPROVEMENTS: Created a competitive edge in the market by continually increasing rapid system deployment capabilities through initiatives that touched all aspects of implementation process within complex, enterprise-level engagements that translated to a 40+% reduction in time to implement and validate.

QUALITY MANAGEMENT/COMPLIANCE: Leveraged extensive compliance background to form a QA team and developed a robust and cost effective QMS that passed 100% of customer Software Quality Audits.

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