HC Quality and Regulatory Advisor at FedEx Express

What you will do :

• The Healthcare Quality & Regulatory Compliance Advisor will be responsible for ensuring that all organizational operations, within the healthcare segment, adhere to quality and regulatory standards. This role serves as a key representative to both internal and external stakeholders, providing expertise in quality management, compliance, and continuous improvement initiatives. The position will also support regional & global customers, ensuring that FedEx network facilities—including hubs, gateways and stations—operate in full compliance with healthcare quality requirements and regulatory expectations.

Key responsibillities :

Quality Assessment & Standards

• Review and approve Standard Operating Procedures (SOPs) and Work Instructions related to transportation and fulfillment operations.
• Ensure alignment of procedures with internal policies, customer expectations, and applicable regulations.

 Quality Process Implementation

• Develop and implement quality processes across the FedEx network and facilities (Hubs, gateways and Stations).
• Establish and maintain policies and procedures to ensure compliance with healthcare standards.
• Provide advisory on quality and regulatory matters to support operational and strategic decision-making.
• Update and maintain FedEx eQMS system

 Quality Management

• Review, monitor, and drive the effectiveness of Quality Corrective and Preventive Actions
• Provide ongoing Quality and Compliance advisory support to operational teams.
• Track and report on quality and compliance performance metrics.
• Lead and support the implementation of Quality Management System (QMS) programs and continuous improvement initiatives.
• Administer QMS documentation and ensure its maintenance and alignment with organizational standards.
• Develop content and provide training on Quality and Regulatory topics
• Lead investigations of complaints received from Customer and prepare CAPA plans, ensuring effectiveness

 Quality Audit

• Design and implement internal audit processes across the healthcare network.
• Prepare and lead  certification audits by external authorities (e.g., ISO, GDP, CEIV etc.).
• Coordinate and lead  customer audit programs, including readiness documentation and audit strategy development.
• Ensure continuous audit readiness  and maintain all relevant documentation.

Healthcare Customer Liaison

• Act as the primary point of contact for healthcare customers on quality and regulatory matters.
• Manage customer requests, issue resolution, and the development or review of Quality Agreements.
• Support healthcare-related RFQs and customer questionnaires & agreements, ensuring compliance and accuracy.

Regulatory

• Good understanding export/import of medical device and Pharma in MEISA countries
• Good understanding of regulatory requirements for imports into US and Europe

You will be a great fit if you

• Masters/bachelor’s degree Pharmacy or equivalent in related discipline.
• Candidates with non-Pharmacy degree must have relevant experience in Quality. Minimum Experience: 5-8 years of relevant experience in pharmaceutical or healthcare industry in a quality compliance related role, regulatory is desired not mandatory
• Good knowledge of GDP/GMP, WHO and IATA CEIV desirable  
• Experience in leading Customer, external authority and supplier audits.

Knowledge, Skills, and Abilities:

• Strong presentation skills
• Proven expertise in influencing, persuading, negotiating and decision making
• Strong in written & verbal communication
• Comfortable networking with anyone both with in India and across the globe
• Microsoft/ Office PC Skills;
• Accuracy & Attention to Detail;
• Problem Solving Skills; Planning & Organizing Skills
• Language: Proficiency in English
• Certifications and Licenses: Local Pharmacist license highly preferred, or 5-8 years' experience in Healthcare Quality function in multi-national Healthcare company (Pharma, Med Device, Clinical Trial).

Posting End Date: 2025-12-20