HC Quality and Regulatory Advisor

FedEx Corporation is an American multinational courier delivery services company headquartered in Memphis, Tennessee. The name "FedEx" is a syllabic abbreviation of the name of the company's original air division, Federal Express, which was used from 1973 until 2000. 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