Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Knowledgeandskillset
Languages
Timeline
Generic

Brian Gandy

Gainesville,Florida

Summary

Leader in Training, Operations & Quality Management

Compliance professional with thorough understanding of regulatory requirements and history of implementing effective compliance programs. Known for fostering team collaboration and achieving results in dynamic environments. Key skills include risk management and regulatory analysis, coupled with adaptability and reliability.

Overview

25
25
years of professional experience
1
1
Certification

Work History

Head of Compliance & Quality Management Systems

Resilience Government Services
01.2024 - Current
  • Oversee Site Compliance program for Training, Auditing, QMS, eLMS & eDMS
  • Delivered and tracked program training for associates and supervisors to safeguard continuing business relationships.
  • Implemented successful remediation efforts following audit findings, minimizing adverse consequences for the organization.


  • Improved operational efficiency by streamlining compliance processes and reducing redundancies.
  • Optimized resource allocation for compliance activities by analyzing data trends and focusing on high-risk areas.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.


  • Established & Monitored Site Metrics & KPI
  • Delivered subject matter expertise for internal and external customers on compliance best practices and quality control.
  • Championed a culture of compliance within the organization, fostering employee awareness and commitment to ethical conduct.


  • Spearheaded training initiatives to improve staff understanding of relevant processes, systems regulations, and best practices.
  • Developed risk mitigation strategies for effective regulatory compliance across the organization.
  • Enhanced internal audit capabilities by creating comprehensive checklists and guidelines.
  • Improved compliance management by implementing streamlined processes and procedures.
  • Played instrumental role in company-wide risk assessment efforts, supporting enhancements in business processes and controls.
  • Assisted with internal and external audits to confirm compliance with applicable laws and regulations.
  • Addressed compliance issues by developing and implementing corrective action plans.


  • Developed compliance training initiatives and materials, educating staff on regulations.
  • Investigated potential compliance violations and reported findings to senior management.
  • Promoted a culture of continuous improvement through ongoing evaluation and refinement of compliance program elements.
  • Collaborated with cross-functional teams to address compliance concerns, fostering a culture of shared responsibility.
  • Strengthened relationships with regulators & clients through proactive communication and collaboration efforts.
  • Monitored key product KPIs and prepared evaluations, assessments, and reports.
  • Established a robust compliance framework, resulting in reduced instances of non-compliance issues.

Sr. Manager of Quality Compliance

Resilience Government Services
03.2022 - 01.2024
  • Oversee QMS in areas of Document, control, Training, Audit program, QMS Records
  • Conduct New Hire Orientation & onboarding functions, GxP & Data Integrity Training

Training Manager

Ology Bioservices
01.2019 - 03.2022
  • Designed Manufacturing Operations Dept Training Curriculum
  • Coordinate Dept
  • Training needs
  • Conduct, lead, Train on Quality Compliance records
  • Lead process improvement projects (Ology University, Line Clearance & Change over activity
  • Equipment logbook program improvement’s, Create & analyze Dept
  • KPIs, create job descriptions)
  • Qualified Trainer (Train the Trainer class)

PROCESS TEAM MANAGER

Saint-Gobain Cohart Refractories
09.2018 - 01.2019
  • Lead Manufacturing team of 40 people in manufacturing operations in glass refractories
  • Responsibilities (budget, hiring, training, meeting company KPIs for production output
  • Schedule adherence, Process Improvements, 5s management, 95% customer satisfaction rating
  • On-time delivery, lean manufacturing, Personnel scheduling, risk assessment management

DIRECTOR OF QUALITY INVESTIGATIONS

MYLAN PHARMACEUTICALS INC.
01.2014 - 01.2018
  • Head of Internal & Complaint Investigation System, CAPA Effectiveness Program & Trending
  • Enforcement of Code of Federal Regulations & Compliance Policies
  • Determine Site & Department Objectives to maintain Quality Compliance
  • Lead Multifunctional Teams on Critical Manufacturing & Quality Projects
  • Ensured Key Quality Attributes were achieved for New Product Launches
  • Presented Critical information to Executive Leadership for entire Site
  • Direct Quality, Technical Support & Operations teams in mitigating deviations & procedural violations

SENIOR MANAGER QUALITY

MYLAN PHARMACEUTICALS INC.
01.2012 - 01.2014
  • Managed 20 plus direct and indirect reports
  • Hired & Trained Quality Team to complete 120 complaint reports a month
  • Designed training modules to support process improvement
  • Reported Scrap levels & compiled data for metric reporting & KPIs

QUALITY MANAGER

MYLAN PHARMACEUTICALS INC.
01.2010 - 01.2012
  • Investigation review and completion
  • Work Directly with Technical Staff to mitigate deviations
  • Developed (monitored & improved) Standard Operating Procedures (SOPs)
  • Batch Record Review

ASSOCIATE MANAGER OF QUALITY

MYLAN PHARMACEUTICALS INC.
01.2007 - 01.2010
  • First responder to deviations on shop floor
  • Investigation Reporting, review, process monitoring & checking
  • Train on Investigation writing and process monitoring

MANUFACTURING SUPERVISOR

MYLAN PHARMACEUTICALS INC.
01.2005 - 01.2007
  • Manage Manufacturing Operational Departments
  • Directed day to day operations to manage outputs and key production metrics
  • Schedule adherence management, training, supervisor workforce of 40+ employees
  • Troubleshoot, enforce polices & procedures, direct daily tasks
  • Provide Conflict resolution to support labor relations

MANUFACTURING COORDINATOR

MYLAN PHARMACEUTICALS INC.
01.2003 - 01.2005
  • Assist Supervisor, prepare operational area for daily tasks
  • Coordinate Schedule
  • Documentation review

MANUFACTURING OPERATOR

MYLAN PHARMACEUTICALS INC.
01.2000 - 01.2003
  • Operate equipment
  • Clean & Clear Operation Suites

Education

MASTER’S DEGREE - Education & Curriculum Design

WEST VIRGINIA UNIVERSITY
Morgantown, WV

BACHELOR OF SCIENCE - Sociology & Human Services

FAIRMONT STATE COLLEGE
Fairmont, WV

Skills

  • Training & Curdd Curriculumlopment Devmentmentkjk
  • Organizational & People development
  • Veeva , Trackwise, MasterControl eQMS wi,ld
  • Change Management Traininig
  • Career development
  • FDA
  • SME in Quality Assurance & Compliance
  • Microsoft Office Suite
  • Root Cause Analysis
  • Quality Risk Management
  • Vendor Assessment
  • Pharmaceutical manufacturing operations
  • Value Stream planning
  • SOP writing
  • OSHA
  • ISO knowledge
  • Training Program development for all GMP departments
  • Quality management processes
  • Regulatory expertise: Biotech, Pharma, Medical Device
  • Document control program
  • Hazard analysis
  • Audit coordination
  • Compliance monitoring
  • Influencing skills
  • Vendor / supplier performance management
  • Ethics management
  • Internal audits
  • Auditing processes
  • Investigations skills
  • Documentation review
  • Training delivery
  • Risk management
  • Project coordination
  • Audit management
  • Trend monitoring
  • Deficiency documentation
  • Compliance procedures
  • Teamwork and collaboration
  • Problem-solving
  • Problem-solving abilities
  • Team leadership

Certification

  • Lean Six Sigma Black Belt Certification
  • Dale Carnegie Leadership Class graduate
  • ASQ-membership
  • Quality Systems Trained in RCA & CAPA completion certificates
  • Change Management – Org Capacity Change course completion
  • Quality Systems expertise in e LMS & QMS expertise in Master Control, Veeva Vault, Track wise

Accomplishments

  • Designed & Developed Training curriculum for MFG Operations at Ology Bioservices & Resilience
  • Streamlined NEO with efficiencies & improvements
  • Planned & Coordinated CGMP training for 200+ employees at Ology Bioservices & National Resilience
  • Directed all Internal & External Investigations, CAPAs, Customer Complaints for 18 billion dose Manufacturing & Packaging Site
  • Directed & Supported Manufacturing Operations for reducing cycle time & decreasing variances
  • Managed Site Continuous Improvement program for 5 years
  • Lead Quality Process improvement Projects to reduce waste by saving Organization on average of $10 million a year
  • Developed Training for Root Cause Analysis methodology & CAPA Effectiveness Program at the Site
  • Trained over 100 Manufacturing & Technical Support personnel in Root Cause Analysis tools
  • Created Standardized Procedures for cleaning and clearing process
  • Aligned best Quality Procedures & Practices at 2 Global manufacturing & packaging Sites
  • Designed Inspection Machine enhancements to improve efficiencies in product quality
  • Supported FDA remediation plan for process improvement at Mylan’s Caguas Puerto Rico & India Sites
  • Improved product Inspection operation capability and quality by conceptualizing machine design
  • Developed and Chaired Trending & Material Review Boards for products and system trends to present data to Leadership
  • Designed Complaints Investigation Group- Hired & Trained

Knowledgeandskillset

  • Understanding of Medical Device Regulations
  • 24+ years pharmaceutical experience
  • Training and curriculum development
  • Organizational development
  • Change Management
  • Career development
  • FDA CFRs
  • SME in Quality Assurance & Compliance
  • Microsoft Office Suite
  • Root Cause Analysis
  • Quality Risk Management
  • Vendor Assessment
  • Pharmaceutical manufacturing operations
  • Value Stream planning
  • SOP writing
  • OSHA
  • ISO knowledge
  • Training Program development for all GMP departments

Languages

English
Full Professional

Timeline

Head of Compliance & Quality Management Systems

Resilience Government Services
01.2024 - Current

Sr. Manager of Quality Compliance

Resilience Government Services
03.2022 - 01.2024

Training Manager

Ology Bioservices
01.2019 - 03.2022

PROCESS TEAM MANAGER

Saint-Gobain Cohart Refractories
09.2018 - 01.2019

DIRECTOR OF QUALITY INVESTIGATIONS

MYLAN PHARMACEUTICALS INC.
01.2014 - 01.2018

SENIOR MANAGER QUALITY

MYLAN PHARMACEUTICALS INC.
01.2012 - 01.2014

QUALITY MANAGER

MYLAN PHARMACEUTICALS INC.
01.2010 - 01.2012

ASSOCIATE MANAGER OF QUALITY

MYLAN PHARMACEUTICALS INC.
01.2007 - 01.2010

MANUFACTURING SUPERVISOR

MYLAN PHARMACEUTICALS INC.
01.2005 - 01.2007

MANUFACTURING COORDINATOR

MYLAN PHARMACEUTICALS INC.
01.2003 - 01.2005

MANUFACTURING OPERATOR

MYLAN PHARMACEUTICALS INC.
01.2000 - 01.2003

MASTER’S DEGREE - Education & Curriculum Design

WEST VIRGINIA UNIVERSITY

BACHELOR OF SCIENCE - Sociology & Human Services

FAIRMONT STATE COLLEGE
Brian Gandy