Kelly Tyler
Cazenovia,NY
Summary
Motivated and dynamic Quality professional with over 20 years of Quality Systems Management (QMS) experience, proven management and leadership abilities, and a strong background in process and system development. Thrives in fast-paced and highly regulated environments with an aptitude for implementing, maintaining and monitoring a fit-for-purpose Quality System processes. Skilled in leading matrix teams and collaboration with a matrix of stakeholders and leaders to drive continuous improvements at a global level. Experience leading Deviation and CAPA, Change Control and Global Documentation teams.
Overview
19
19
years of professional experience
Work History
Senior Manager (Associate Director) Corporate QMS
Amgen
09.2021 - Current
- Ownership of Corporate Quality Management Systems (Deviation, CAPA and Change Control)
- Lead network team of site subject matter experts to drive collaboration and implement continuous improvement opportunity
- Provide leadership and direction to team of Quality Professionals, including GPOs
- Support Quality Management Review activities and oversee key performance metrics
- Key representative for internal and external inspections
- Reviewed and assessed regulations to ensure compliance with evolving global health authority requirements
- Implementation of new Quality System platform transformation (Trackwise to Veeva)
Senior Manager, Compliance
Bristol Myers Squibb
08.2016 - 09.2021
- Ownership of Change Control and Documentation Management processes
- Responsible for team of 10+ Quality Assurance professionals
- Led implementation of new Quality System Platform (Trackwise to Veeva)
- Drove Continuous Improvement efforts, ensuring agile and fit-for-purpose Quality Management Systems
- Supported Quality Management Review activities including Ownership of Key process indicators and metrics
- Front room facilitator for external and internal inspections (participation in over 15 inspections)
- Led cross function Change Control Review Board to drive collaboration and stakeholder involvement
- Core team member of Corporate Change Control Network team
- Oversight of the quality manual, policies and procedures, as well as compliance verification processes for QMS global documentation including directives, policies, and global SOPs
Quality Systems Specialist
Amgen
05.2006 - 12.2014
- Global Change Control Manager for Quality Control
- Ownership of the global change control process at the site level
- Guidance, support, ownership and quality approval of global change controls
- Lead global review board for commercial change management
- Supported site implementation of new QMS documentation system, eDMS
- Leadership, coordination and planning of method revisions with multiple departments, sites, contract manufacturers, and Amgen partners
- Lead multiple Quality improvement projects and lean initiatives
- Ownership of complex Level 1 and 2 critical Nonconformance and CAPA records
- Authored, reviewed and approved of technical reports, protocols and investigations for QC Laboratories
- Review and approval of method revisions to ensure compliance with regulatory commitments
- Reviewed and approved SOPs and Forms
Quality Assurance Specialist
Bristol Myers Squibb
09.2004 - 12.2006
- 'On the manufacturing floor' Quality oversight of upstream and downstream processing to ensure compliance with cGMP regulations and company procedures
- Provided guidance on cGMP issues and interpretation of procedures
- Authored and reviewed SOPs and Manufacturing Batch Records
- Participated in internal audits and closing out audit observations.
- Performed Inspection and release of incoming consumable materials
- ·Authored operational variance reports and failure investigations
- ·Reviewed and approved pre/post approvals for work orders and calibration functions
Education
Bachelor of Science - Biology
SUNY College of Environmental Science And Forestry
Syracuse, NYSkills
- Design and Implementation of Quality Systems
- Continuous Improvement
- Change Control
- Deviation and CAPA
- Document Control Systems
- Cross-Functional Team Management, Training and Development
- Ownership of quality system performance metrics
- GMP, GCP and GDP global regulations
- Audit and Inspection
- Combination Products/Devices
Timeline
Senior Manager (Associate Director) Corporate QMS
Amgen
09.2021 - Current
Senior Manager, Compliance
Bristol Myers Squibb
08.2016 - 09.2021
Quality Systems Specialist
Amgen
05.2006 - 12.2014
Quality Assurance Specialist
Bristol Myers Squibb
09.2004 - 12.2006
Bachelor of Science - Biology
SUNY College of Environmental Science And Forestry