Summary
Overview
Work History
Education
Skills
Computer Software Expertise
Certification
References
Work Availability
Timeline

KEVIN CHALMERS

MECHANICSVILLE,VA

Summary

Experienced Quality Assurance professional with a strong attention to detail and expertise in developing and implementing effective quality procedures, standards, and specifications. Demonstrated ability to clearly communicate quality requirements and monitor performance. Proven track record of making timely, quality-based decisions through analysis, experience, judgment, and technical knowledge.

Overview

32
32
years of professional experience
1
1
Certification

Work History

Managed Services Consultant, Quality

VEEVA SYSTEMS
Remote
11.2021 - 09.2024
  • Provide post go-live configuration and administrative assistance to multiple clients
  • Solutioning and configuration of Vault applications to meet customer needs, including, but not limited to Documents, Lifecycles, Objects, Security and Workflows
  • Import/Export of content and data
  • Analysis, deployment and support of new product features
  • Maintenance of multiple Vault environments
  • Creation of client reports
  • Develop customized solutions leveraging existing Vault applications

Director, QA Operations

KALEO
Richmond, VA
01.2019 - 07.2021
  • Led a team of five and managed responsibilities in Quality Control, Validation, and Quality Assurance.
  • Collaborated with manufacturing department to maintain consistent kaleo message for suppliers
  • Partnered effectively with suppliers in order to maintain regulatory standards for manufacturing of combination product
  • Hosted Pharmacovigilance audit resulting in zero observations
  • Reviewed and approved supplier deviations, investigations, and change controls
  • Ensured effective partnerships and valuable insights through regular participation in Joint Steering Committee meetings
  • Prepared and submitted FDA Field Alert Reports, as needed
  • Worked together with suppliers to rectify concerns highlighted in their audit reports

Manager, Regulatory Compliance

INDIVIOR
Richmond, VA
04.2015 - 01.2019
  • Designed and implemented advanced training frameworks in ComplianceWire to support the Global Regulatory Affairs team
  • Reviewed and approved Standard Operating Procedures related to Regulatory Affairs processes
  • Contributed to the assessment and revision of product labeling processes.
  • Reviewed key documents for mock and Health Authority inspections

Associate Director, Quality Operations Audits & Compliance

FAREVA RICHMOND, INC
Richmond, VA
09.2011 - 04.2015
  • Managed a team of nine professionals, consisting of eight exempt employees and one temporary worker
  • Managed Audit, Complaint, Annual Product Review, and Supplier Management departments
  • Successfully hosted various Health Authority inspections while minimizing 483 observations
  • Coordinated development of a site's new risk-based GMP gowning policy
  • Oversaw frequent customer audits and coordinated internal and regulatory audit activities
  • Ensured new Supplier Management process meets potential future regulatory expectations
  • Managed the implementation of MasterControl to streamline Supplier Management and Complaint processes.
  • Coordinated site meetings for critical GMP issues
  • Ensured prompt dissemination of crucial GMP issues to customers
  • Ensured facility was consistently prepared for inspections through frequent walk-through audits
  • Ensured all consumer complaint evaluations are completed within required customer timeframes

Associate Director, Quality Operations TPPU

PFIZER / WYETH
Richmond, VA
11.2008 - 09.2011
  • Managed a group of five exempt professionals
  • Managed record review, investigations, and technical specifications
  • Streamlined record review process by implementing organizational improvements in existing department
  • Reduced release cycle times for finished products
  • Reviewed, approved and enhanced site change controls, investigations and procedures
  • Managed and enhanced CAPA program
  • Served as the primary point of contact to align site investigation process with new expectations

Manager, Quality Assurance Investigations/Complaints

Wyeth
Richmond, Virginia
08.1992 - 04.2008
  • Managed a group of 3 to 7 exempt professionals
  • Reviewed, revised and/or approved site investigations and procedures
  • Ensured safety measures were in place when evaluating complaint samples
  • Led efforts towards developing effective LIR and MIR writing guides
  • Led the team in creating a comprehensive guide for managing customer complaints
  • Effectively managed and coordinated the Global Product Conformance initiative at the Richmond facility
  • Contributed to the development and successful implementation of SAP CAPA system
  • Reviewed site investigations
  • Established a comprehensive set of guidelines aimed at promoting clarity and consistency in laboratory investigation writing
  • Created Excel templates used for result generation and equipment logbooks
  • Executed method validations

Education

BACHELOR OF SCIENCE, CHEMISTRY -

Longwood College, Farmville, VA
01.1992

Skills

  • Analytical mindset
  • Compliance Monitoring
  • Continuous Improvement
  • Decision-Making
  • Document Management
  • Mastery of quality processes
  • Problem-solving abilities
  • Quality Management Systems
  • Quality Inspection
  • Records Management
  • Self-Directed
  • Vendor / Supplier Performance Management
  • Audits management
  • Investigative skills

Computer Software Expertise

  • Microsoft Applications (Excel, Outlook, PowerPoint, SharePoint, Teams, Word)
  • SAP (CAPA, Change Control, MRP)
  • MasterControl (CAPA, Complaints, Deviations, Document, Issues, MOC, Supplier Management)
  • Veeva (Platform, QualityDocs, QMS, Training)

Certification

  • Veeva Administrator White Belt (Platform, QualityDocs, QMS)

References

References available upon request.

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Managed Services Consultant, Quality - VEEVA SYSTEMS
11.2021 - 09.2024
Director, QA Operations - KALEO
01.2019 - 07.2021
Manager, Regulatory Compliance - INDIVIOR
04.2015 - 01.2019
Associate Director, Quality Operations Audits & Compliance - FAREVA RICHMOND, INC
09.2011 - 04.2015
Associate Director, Quality Operations TPPU - PFIZER / WYETH
11.2008 - 09.2011
Manager, Quality Assurance Investigations/Complaints - Wyeth
08.1992 - 04.2008
Longwood College - BACHELOR OF SCIENCE, CHEMISTRY,

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