Manager Healthcare Quality

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. The Manager in Healthcare Quality also monitors regulatory changes, manages compliance programs, and works with various stakeholders to ensure overall adherence to quality and compliance standards.

In this position, you will provide advice and guidance at the regional/divisional level and effectively manage a team of professionals and/or subject matter experts. Responsibilities may include interfacing with Corporate level management.

• Maintain quality management systems (QMS) that meet both internal standards and external regulatory requirements.
• Conduct internal and external audits and assessments to ensure compliance with quality standards, regulations, and company policies.
• Monitor regulatory changes and stay up to date on relevant regulations and industry standards, including CEIV, IATA, ISO, GDP, and other specific requirements.
• Develop and implement comprehensive compliance programs, including policies, procedures, and training materials.
• Investigate quality-related incidents, deviations, and non-conformities, and develop corrective and preventive actions (CAPA).
• Drive continuous improvement by identifying areas for enhancement in quality processes and systems and implementing solutions to increase efficiency and effectiveness.
• Provide training to employees on quality and compliance-related topics, including but not limited to GDP, IATA, and CEIV certifications.
• Prepare reports on quality and compliance performance and communicate findings to relevant stakeholders.
• Collaborate with various departments, such as R&D, production, and marketing, to ensure quality and compliance throughout the product lifecycle.
• Identify and assess potential quality and compliance risks and develop mitigation strategies.
• Plan, organize, and direct quality management processes and systems.
• Provide quality guidance, support, and advice to the quality team, internal stakeholders, external customers, vendors, and regulatory bodies.
• Utilize electronic quality systems with an understanding of regulatory requirements.
• Identify, manage, and perform continuous improvement projects to ensure customer satisfaction and business continuity.
• Perform or review deviation investigations and CAPAs.
• Perform or review Quality Agreements and Supplier Qualifications.

Performs other duties as assigned.

What is required to succeed in this role:

• Bachelor’s degree or equivalent in healthcare quality or safety, transportation, business, information systems, computer science, science, or another scientific or quantitative discipline.
• Minimum of five (5) years’ experience in pharma quality in manufacturing, laboratories, or distribution, or closely related experience, including experience in business, transportation, logistics, or supply chain management. Deviation experience required.
• Proficient Office 365 skills.
• Strong management, human relations, project management, analytical, and communication skills. Ability to train, communicate, and present clearly, both orally and in writing, to all business levels.
• Ability to collaborate with business areas, customers, vendors, systems users, and technical developers.
• Knowledge of European regulatory compliance.
• Lean/Six Sigma training preferred.

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.

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 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.