Directed Commissioning, Qualification, and Validation (CQV) OpEx and CapEx operations for 7 facilities (6 in NH and 1 in WI). Developed and led a cross-functional CQV organization to provide cost-effective and efficient solutions for Analytical Instrument Qualification (AIQ), Computer Systems Validation (CSV), Equipment/Facilities/ Systems/Utilities Qualification, and Process Validation (PV). Developed site validation master and sub-plans. Engaged in vendor contract negotiations. Reviewed and approved proposals and contracts for clients. Directed the remediation of Events, Deviations, and CAPAs related to CQV. Developed and updated the CQV QMS to align with updates. Participated in regulatory agency audits.Notable Contributions: • Built and developed the team from 2 to 9 full-time employees and 48 contractors.• Immediately recovered 3 $70M building projects after hire to bring them back on schedule.• Developed an internal quality system for a scalable, integrated, risk-based, and right-first-time CQV approach to greenfield CapEx projects, which reduced overall CQV costs by 45% and the timeline by ~25%.• Designed and implemented successful remediation and recovery strategies for pre-onboarding CapEx projects, resulting in on-time project delivery.• Spotlighted by Human Resources for Diversity, Equity & Inclusion (DEI) efforts.

Notable Engagements: Engineering, Validation, QA, and QS DirectorDirected equipment, systems, and utilities installation/upgrade projects for QC micro/bio. Drove the implementation of enterprise systems for clinical and regulatory groups. Oversaw the implementation of enterprise systems for QA and Engineering groups.o Developed and implemented Quality systems for GxP project management, engineering, and CQV, reducing labor costs.o Designed a training program for right-first-time GxP project controls and execution best practices, which aligned best practices to improve compliance and reduce labor costs.o Created a Data Integrity program and performed site-wide DI gap assessment for QC micro/bio, manufacturing, facilities, and utilities.Engineering DirectorBrought on to lead the design and execution activities at a $170M facility, including FUSE design, budget planning, and procurement plans. Coordinated CQV services, staff resources, vendors, project management, and engineering. o Prioritized installation, startup, troubleshooting, and CQV for process utilities, parts prep, media/buffer, bioreactor suites, QC, and purification. Validation LeadGuided the development of engineering and validation quality systems, defining needs and staffing for the engineering and validation groups, developing the site validation master plan, defining the annual budget, and developing a five-year budget forecast.o Directed CQV activities for the client’s new facility, including quality system development, start-up, and CQV for upstream, downstream, automation, utilities, and GxP systems.o Consistently reduced costs and timelines with better resource allocation; staffed and supervised cross-functional teams to perform assessments, identify deficiencies, and develop remediation strategies.o Managed cleaning and steaming validation activities and the global Data Integrity remediation program.

Directed operations for commissioning, qualification, and validation (CQV) and compliance groups for the US business unit. Spearheaded the effort to develop the ISO 9001 program.

Directed process and facilities engineering, commissioning, qualification, and validation (CQV) program for the physical plant remediation. Developed and directed cross-functional leads and support staff to drive cost-effective and efficient efforts for 19 major initiatives. Supervised a computer systems validation department consisting of 5 FTEs and 2 consultants. Managed RS3 and DeltaV qualification efforts to include the development and execution of IQ, OQ, PQ, and CQ protocols following cGMPs.

Defined, coordinated, and managed response and execution of resolution for automation, IT, facilities, and maintenance-related CAPAs that led to the closure of 483 line items.