Director of Quality 1

• Establishes and maintains the Pelican BioThermal Quality vision, mission, and strategy.
• Manages and provides leadership to Quality teams including Quality Assurance, Quality Systems, and Quality Control departments for Pelican BioThermal.
• Leads Quality Assurance oversight of product release, documents and records control, production and services, approval of process deviations, change management controls, compliance, and investigations.
• Leads Quality Systems Management including the Quality Compliance, in-house compliance systems and audits as well as Client and Supplier audits. Maintains and executes to an up-to-date knowledge base for the QMS (should include: cGMP, ISO, client compliance requirements).
• Leads Quality Engineering operations including Validation, Technical Operations, Technical Troubleshooting, and CAPA.
• Oversees Quality Risk Management activities.
• Drives technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance.
• Serves as the Management Representative to ensure the processes need for the quality management system are established, implemented, and maintained; and acts as the liaison to external bodies/agencies for the purposes of achieving and maintaining certifications.
• Hosts ISO re-certification and any regulatory inspections, leads inspection readiness activities, and manages responses and closure of inspection findings.
• Establishes and maintains Pelican BioThermal KPI’s and Customer Satisfaction metrics.
• Ensures that the Closed Loop Corrective Action and Customer Complaint processes are established and integrated throughout Pelican BioThermal – Examples: a) Complaints/feedback system and b) single source point-of-contact for customers with quality concerns regarding products and services.
• Develops a unified approach to and application of Environmental Quality Management System (EQMS) to ensure compliance in all our major markets and eliminates redundancies.
• Actively participates in new product development cycles to ensure customer and defined requirements are achieved.
• Implements new product release controls for critical quality issues and ensures the Voice of the Customer (VOC) is considered (i.e. implementation of change management to comply with and meet pharma industry standards)
• Establishes, sustains and improves the Warranty and Repair policies for all products and services.
• Together with Sourcing, identifies and engages key vendors that are crucial to the success of the Pelican group and monitors their progress and performance improvements (i.e. Supplier metrics and scorecard).
• Sets appropriate goals and targets to ensure that key performance indicators are being satisfied; assists any and all Pelican BioThermal departments to develop meaningful quality systems, metrics and methods.
• Responsible for overall training and development initiatives for quality assurance and quality control staff, coaches and counsels direct reports in their performance and professional development, and has overall authority for approving pay increases, hiring decisions and disciplinary actions.
• Actively supports Pelican’s commitment to Quality and all quality objectives, with an emphasis on continual improvement.
• Follows company policies and practices as outlined in the Employee Handbook and/or applicable employment agreement. Follows safety guidelines and procedures in accordance to the job.
• Perform special projects and additional duties as assigned by the President.

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