KELLY TYLER
Cazenovia,NY
Summary
Director-level Quality Systems leader with global ownership of enterprise eQMS platforms and GMP quality processes across Deviations, CAPA, Change Control, Complaints, Training, and Document Control. Partners with Quality, IT, R&D, PVMA, Manufacturing, and Compliance to align workflows, support data integrity, and maintain inspection-ready systems and controlled documentation.
Overview
20
20
years of professional experience
Work History
Director GMP Quality Management Systems
Daichi Sankyo
Basking Ridge, New Jersey
09.2024 - Current
- Serve as global business owner and governance lead for the enterprise eQMS (TrackWise Digital) across GMP quality process modules (e.g., Deviations, CAPA, Change Control, Complaints, Training, Document Control).
- Led global QMS harmonization and standardization initiatives, driving consistent process design, controlled documentation, and change management across regions and sites.
- Directed eQMS system specifications and configuration documentation, partnering with IT/validation to support risk-based CSV activities, release management, and compliant system lifecycle controls.
- Led eQMS integration (TrackWise–SAP) to enable end-to-end quality event traceability and data flow governance, enhancing reporting and metrics for stakeholders and leadership.
- Functioned as primary liaison between Quality and IT to define an eQMS roadmap, translating business requirements into user stories, functional specifications, and scalable system solutions.
- Partner with Global Process Owners, R&D, PVMA, Manufacturing, and Compliance to maintain fit-for-purpose workflows, ensuring data integrity (ALCOA+) and inspection readiness.
- Collaborated with teams remotely to ensure project progress.
Senior Manager (Associate Director) Corporate QMS
Amgen
Thousand Oaks, California
09.2021 - 09.2024
- Led enterprise eQMS platform transformation (TrackWise to Veeva) to define requirements, manage configuration, and support risk-based CSV and release management.
- Chaired a network of site SMEs and process owners to harmonize processes, enhance KPI performance, and foster continuous improvement across global quality system.
- Provided leadership and direction to a team of Quality professionals and Global Process Owners (GPOs), establishing governance cadence, decision rights, and effective stakeholder communications.
- Owned QMS performance metrics and management review inputs (trending, dashboards, KPI reporting) to facilitate data-driven prioritization and implemented targeted corrective actions.
- Acted as a key Quality Systems representative for internal, supplier, and health authority inspections, facilitating effective preparation, execution, and timely follow-up on responses and commitments.
- Owned corporate QMS processes and governance for Deviation, CAPA, and Change Control, ensuring global standardization, compliance, and sustained inspection readiness.
- Worked remotely to support quality initiatives and team collaboration.
Senior Manager Compliance
Bristol Myers Squibb
Syracuse, New York
08.2016 - 09.2021
- Owned site Change Control and Documentation Management processes, ensuring alignment to global QMS requirements and sustained GMP compliance.
- Led and developed a team of 10+ Quality Assurance professionals, setting priorities, coaching performance, and driving consistent execution across QMS activities.
- Led deployment of a new quality system platform (TrackWise to Veeva), partnering with IT and stakeholders to define requirements, supporting testing/validation activities, and enabling adoption.
- Executed continuous improvement initiatives to simplify workflows, enhance right-first-time execution, and maintain agile, fit-for-purpose quality management system.
- Managed key process indicators and performance metrics, facilitating Quality Management Review through trending, reporting, and action tracking.
- Served as front-room facilitator for internal and external inspections (15+), coordinating SMEs, managing real-time requests, and supporting timely responses and commitments.
- Led cross-functional Change Control Review Board, fostering stakeholder engagement, guiding risk-based decision-making, and ensuring timely implementation of changes.
- Represented the site on the Corporate Change Control Network, aligning practices, sharing best practices, and supporting global harmonization.
- Oversaw the Quality Manual and controlled documentation (policies, directives, global SOPs), including compliance verification and periodic review to maintain current, effective procedures.
Quality Systems Specialist
Amgen
Longmont, Colorado
05.2006 - 12.2014
- Provided quality oversight and approval for global change controls, including impact assessments, documentation review, and compliance to regulatory commitments.
- Managed global change control for analytical control, ensuring governance and oversight for complex, multi-site changes.
- Owned site-level change control process execution, ensuring adherence to SOPs, timely approvals, and effective implementation controls.
- Facilitated risk-based decisions and cross-functional alignment as the leader of the global commercial change management review board.
- Coordinated analytical method revisions across departments, sites, contract manufacturers, and partners to ensure aligned execution and controlled implementation.
- Led quality improvement projects and lean initiatives to reduce cycle time and improve compliance and process performance.
- Oversaw Level 1 and Level 2 nonconformance and CAPA records, ensuring thorough investigation, root cause analysis, and implementation of effective corrective/preventive actions.
- Supported site implementation and sustainment of an electronic documentation management system (eDMS), including procedure updates and user adoption support.
- Authored, reviewed, and approved technical reports, protocols, and investigations supporting QC laboratory operations and regulatory compliance.
Education
Bachelor of Science - Biology
SUNY College of Environmental Science and Forestry
Syracuse, NYSkills
- Global QMS leadership
- QMS ownership
- Quality transformation
- Quality metrics
- Inspection readiness
- Global standardization
- Computer system validation
- Data compliance
- IT partnership
- System integration and data flow
- Team performance management
Timeline
Director GMP Quality Management Systems
Daichi Sankyo
09.2024 - Current
Senior Manager (Associate Director) Corporate QMS
Amgen
09.2021 - 09.2024
Senior Manager Compliance
Bristol Myers Squibb
08.2016 - 09.2021
Quality Systems Specialist
Amgen
05.2006 - 12.2014
Bachelor of Science - Biology
SUNY College of Environmental Science and Forestry