EQ970: Manager Healthcare Quality (ID)

Description

Healthcare Quality: 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.

To provide advice and guidance at regional/divisional level and effectively manage a team of professionals and/or subject matter experts.  Responsibilities may include interfacing with Corporate level management.

• 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.

What is required to succeed in this role:

• 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

FedEx was built on a philosophy that puts people first, one we take seriously. We are an equal opportunity employer and we are committed to a diverse and inclusive workforce in which we provide growth opportunities for all

Our Company

FedEx is one of the world's largest express transportation companies and has consistently been selected as one of the top 10 World’s Most Admired Companies by "Fortune" magazine. Every day FedEx delivers for its customers with transportation and business solutions, serving more than 220 countries and territories around the globe. We can serve this global network due to our outstanding team of FedEx team members, who are tasked with making every FedEx experience outstanding.

Our Philosophy

The People-Service-Profit philosophy (P-S-P) describes the principles that govern every FedEx decision, policy or activity. FedEx takes care of our people; they, in turn, deliver the impeccable service demanded by our customers, who reward us with the profitability necessary to secure our future. The essential element in making the People-Service-Profit philosophy such a positive force for the company is where we close the circle, and return these profits back into the business, and invest back in our people. Our success in the industry is attributed to our people. Through our P-S-P philosophy, we have a work environment that encourages team members to be innovative in delivering the highest possible quality of service to our customers. We care for their well-being, and value their contributions to the company.

Our Culture

Our culture is important for many reasons, and we intentionally bring it to life through our behaviors, actions and activities in every part of the world. The FedEx culture and values have been a cornerstone of our success and growth since we began in the early 1970’s. While other companies can copy our systems, infrastructure and processes, our culture makes us unique and is often a differentiating factor as we compete and grow in today’s global marketplace.