Mgr Quality & Process Improvement

Sets strategies for transforming business processes and operational tools to achieve global excellence. Ensures products, services, and operations adhere to established quality standards and regulatory requirements. This role involves developing and implementing quality management systems, conducting audits, and driving continuous improvement initiatives. They also monitor regulatory changes, manage compliance programs, and work with various stakeholders to ensure overall adherence to quality and compliance standards.

• Maintaining quality management systems (QMS) that meet both internal standards and external regulatory requirements.
• Conducting Audits and Assessments:
  Performing internal and external audits to assess compliance with quality standards, regulations, and company policies.
• Monitoring Regulatory Changes:
  Staying up to date on relevant regulations and industry standards, including CEIV, IATA, ISO, GDP and other specific requirements.
• Managing Compliance Programs:
  Developing and implementing comprehensive compliance programs, including policies, procedures, and training materials.
• Investigating Incidents and Non-Conformities:
  Investigating quality-related incidents, deviations, and non-conformities, and developing corrective and preventive actions (CAPA).
• Driving Continuous Improvement:
  Identifying areas for improvement in quality processes and systems and implementing solutions to enhance efficiency and effectiveness.
• Training and Development:
  Providing training to employees on quality and compliance-related topics.
• Reporting and Communication:
  Preparing reports on quality and compliance performance and communicating findings to relevant stakeholders.
• Stakeholder
  
  Collaboration:
  
  Working with various departments, such as R&D, production, and marketing, to ensure quality and compliance throughout the product lifecycle.
• Risk Management:
  
  Identifying and assessing potential quality and compliance risks and developing mitigation strategies.
• Plans, organizes, and directs the quality management processes and systems.
• Provide Quality guidance, support, and advice to quality team, internal stakeholders and external customers, vendors and regulatory bodies.
• Perform functions utilizing electronic quality systems with an understanding of regulatory requirements.
• Identify, manage and perform continuous improvement projects to ensure customer satisfaction and business continuity.
• Performs or reviews deviation investigations and CAPAs.
• Performs or reviews Quality Agreements and Supplier Qualifications.
• Performs training included but not limited to GDP, IATA and CEIV certifications.
• Performs other duties as assigned.

Bachelor’s degree/equivalent in healthcare quality or safety, transportation, business, information systems, computer science, science or other scientific or quantitative discipline.

Five (5) years’ minimum experience required in pharma quality in manufacturing, laboratories or distribution or closely related experience and including experience in business, transportation, logistics or supply chain management. Deviation experience.

Proficient Office 365 skills required.

Strong basic management, human relations, project management, analytical and communication skills required. Ability to train, communicate and present clearly, both orally and written to all business levels.

Must be able to collaborate with business areas, customers, vendors, systems users, and technical developers.

Knowledge in European regulatory compliance.

Lean/Six Sigma training preferred.

Business travel required

This position will require some travel for vendor visits, site investigations and certifications.

Quality Assessment & Standards:
Transportation & Fulfilment SOP & Work Instruction Development;
Fed Ex Network and Facilities (Hubs, Stations)

Policies & Procedures Development & Implementation;
Quality & Regulatory Advisory;
Quality Management:
Quality Corrective & Preventive Actions;
Quality & Compliance Advisory;
Quality & Compliance Performance;
Compliance & Quality Program Implementation;
Continuous Improvement of QMS &…