Paul Buckley
Associate Director, Quality @Entrada Therapeutics
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WORK HISTORY
Associate Director, Quality @Entrada Therapeutics
Leads Document Control department. Oversee, writes, reviews and /or approves Standard Operating Procedures (SOPs) for Documentation Management program. Delivers expertise and guidance to drive continuous improvement of standardized processes for managing GxP documents/records.• Leads Training Program. Implements and improves phase appropriate procedures for training and qualification. Facilitates and oversees the new hire training program and other activities related to Personnel Management. • Leads and oversees implementation of GxP compliant deviation, CAPA and change controls programs. Collaborates with internal stakeholders on continuous improvement of the processes using phase appropriate and risk-based approach.· Oversees and drives GxP Vendor management program. Responsible for generation of yearly audit schedules and timely audit execution of GxP audits.• Implements and improves GxP risk management program. Leads understanding and adoption of risk assessments and plans.• Drives Computer System validation activities to assure System Development Lifecycle Processes at Entrada are GxP compliant. Partners with IT team and functional area SMEs on validation of computer systems. Supports the audit team with evaluation of computer systems compliance at vendors.• Leads development, implementation, and execution of KPIs and metrics. • Leads planning and execution of Internal Audit Program.• Leads planning and execution of Quality Management Review Program.• Represents QMS and compliance in regulatory inspections.• Act as a backroom lead during audits and regulatory inspections.• Provides leadership, guidance, and directions to staff and across Entrada’s various departments consistent with GxPs and best business practices. • Supports other members of the Quality team and organization in aspects not related to the core responsibilities of the Quality Management Systems and Compliance area.
EDUCATION
Curry College
Bachelor of Science (B.S.), Biology and Philosophy
Clarkson University
Bio-Molecular Science and Chemistry
SKILLS
ABOUT PAUL BUCKLEY
Summary of Qualifications:• Computer System Validation (CSV) to meet 21 CFR Part 11, EU Annex 11, General Data Protection Regulation (GDPR), Drug Supply Chain Security Act (DSCSA), GAMP, and/or GxP requirements• QMS and Training Management• CDMO/CMO, CLO/CTO, and Vendor Management• Risk Management and Continuous Improvement• Technical writing including SOPs, Protocols, Training Materials, and Quality Agreements• Batch Record Review and Lot Disposition• Internal and External Auditing Experience• Metric Capture, Analysis, and Reporting
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