Experienced Quality Operation Manager with Proven Success in Managing Projects and Driving Continues Improvement.
As a seasoned professional with expertise in quality management, supply chain, and regulatory compliance, I have a proven track record of success in managing multiple projects focused on materials, process, deliveries, resources, and implementing best business practices that improve quality, compliance, efficiency, and reduce operating costs.
With a passion for continuous improvement to identifying and implementing new strategies that enhance organizational performance.
I am now seeking a challenging new opportunity that will enable me to apply my existing skills and experience while fostering personal and professional growth.
• Led multiple plant's quality organization across Canada and U.S.A. Directing
and managing quality activities.
• Led and managed change initiatives inclusive of planning, execution and
tracking the milestones such as communications, training, stakeholder
engagement, risk assessment, change impact assessment, organizational
readiness analysis, post implementation support & reinforcement, lessons
learned and continuous improvement of current methodologies and
processes.
• Developed, generated, and facilitated a robust Reporting structure and
action plans, SWOT analysis and Roadmap for the global and divisional
quality objectives, goals, strategies, and metric to ensure their alignment
with the business and operational strategies.
• Identified and developed roles and responsibilities, RACI and team
configuration to deliver the agreed-upon goals and objectives across
operational functions.
• Actively drove the integration of newly acquired plants to transform their
legacy quality and regulatory systems to implement best practices and
global management system to complete integration process.
• Implemented industry best practices quality operational system through
development of robust processes and quality plans. Led QMS team for
Integration, Standardization, and harmonization of quality management
system across multiple newly acquired plants by developing, integrating,
and deploying strategic plans and practices across the division and
business unit.
• Led North American plants' quality organization for conformance to all
quality requirements including CAPAs, Quality Notifications (QN), Internal
NCMRs, Customer complaints, Customer requests, Management Review
(QMRBs), CCRBs, Customer audits, internal and external audits, eQMS, ISO
9001, ISO 14001, 8D process, FMEA, Control plans, IPO, Process control
systems (PCS), Statistical Process Control (SPC), NPD phase gate review,
and other quality tools.
• Provided ongoing coaching and mentoring to quality and operational team.
• Built an effective partnership with the plant operation’s team including
process engineering, R&D, QC laboratory and product management to
improve operational effectiveness.
Master of Business Administration (MBA)
Diploma in Pharmaceutical Quality Control and Regulatory
B.Sc. in Chemistry (Eval.)
Lead Auditor- ISO 19011:2018
Lead Auditor- ISO 19011:2018
QMS ISO 9001:2015
GMP Essentials
Certified Quality Engineer-CQE
Certified Quality Auditor-CQA
Six Sigma Green Belt
Project Management