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HC Quality and Regulatory Advisor
"Please note that the Job will close at 12am on Posting Close date, so please submit your application prior to the Close Date"
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 responsibilities :
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 India and MESA 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 : License: Local Pharmacist license highly preferred, or 5-8 years experience in Healthcare Quality function in multi-national Healthcare company (Pharma, Med Device, Clinical Trial)
Microsoft/ Office PC Skills; Accuracy & Attention to Detail; Written & Verbal Communication Skills; Problem Solving Skills; Planning & Organizing Skills
FedEx was built on a philosophy that puts people first, one we take seriously. We are an equal opportunity/affirmative action employer and we are committed to a diverse, equitable, and inclusive workforce in which we enforce fair treatment, and provide growth opportunities for everyone.
All qualified applicants will receive consideration for employment regardless of age, race, color, national origin, genetics, religion, gender, marital status, pregnancy (including childbirth or a related medical condition), physical or mental disability, or any other characteristic protected by applicable laws, regulations, and ordinances.
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.
