Lonza · 2 days ago

Manager, Quality Assurance Operational Excellence

Tampa, FL

Full-time

Onsite

Senior Level

7+ years exp

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BiotechnologyLife Science

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Responsibilities

Plan, lead, drive and execute business critical improvement projects to deliver successful results using Lean/DMAIC approach.

Achieve goals through the application of continuous improvement and contribute to shaping Tampa Strategy development and delivery, organizational development and culture leadership.

Act as a subject matter expert for the site by coaching others in the philosophy, methods, tools and techniques of process improvement to increase the capability of the business to respond to problems

Coach teams to establish performance measurements and process control plans to monitor project results and drive sustainability. Communicate project progress and promote project achievements to maintain awareness of improvement activity on the site, across the network and with corporate leadership.

Implement and maintain adequate measurements and control systems to identify improvement opportunities/needs.

Develop OE strategic plans and deployment including metrics setting and reporting.

Partner with SLT, global OE, and corporate leadership on driving Lean Six-Sigma projects to increase productivity and enhance effectiveness of operation processes and systems.

Participate and contribute to the global OE network and share best practices.

Provides Quality leadership to ensure that QA activities, manufacturing and packaging operations are conducted in compliance with SOPs, cGMP standards and FDA regulations.

Creates, develop, implement and maintain departmental systems that foster a culture of quality and continuous improvement focused on value to the customer.

Disseminates Quality best practice throughout the organization through training, presentations, etc..

Participate in internal, client and/or regulatory audits.

Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.

Participates in deviation investigations, root cause analysis, impact assessments, and corrective or preventive actions.

Development, implementation and management of all quality systems and activities

Establish, maintain, trend and report Quality KPI and metrics.

Lead/Participate in Management Review, Quality Review Board, Deviation Review Board and Change Review Board.

Lead/Participate in Risk Analysis/Risk Management activities.

Other tasks as assigned by Head of Quality

Qualification

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Pharma cGMPGreen Belt CertificationScienceBlack Belt Certification