HC Quality and Regulatory Advisor

Description

1. Quality Assessment & Standards: Transportation & Fulfilment SOP & Work Instruction Development; FedEx Network and Facilities (Hubs, Stations) Policies & Procedures Development & Implementation; Quality & Regulatory Advisory
2. Quality Management: Quality Corrective & Preventive Actions; Quality & Compliance Advisory; Quality & Compliance Performance; Compliance & Quality Program Implementation; Continuous Improvement of QMS & Processes; QMS Implementation & Administration
3. Quality Audit: Internal Audit Process Design & Implementation; Certification Audit; Customer Audit Programs; Audit Strategy & Readiness Program Documentation; Audit Program
4. Healthcare Customer Liaison: Customer Request / Issue Resolution; Quality Agreements, Questionnaires & RFQ Proposal

Title – Healthcare Quality & Regulatory Compliance Advisor

Department - Quality

Number of positions - 1

Location : Johannesburg, South Africa

Who we are

At FedEx, moving the world doesn't only mean delivering for our customers around the globe. Moving the world is also about creating what's next. We are Team FedEx and we are 500,000+ people strong around the world. The work we all do comes down to one purpose: to provide our customers with outstanding experiences as we connect the world to what's next.

This isn't a place to get just a job. Here, you get a career for life. Its a place to enjoy constant change, growth, and progress in your career. Our willingness to innovate and transform is what keeps us at the forefront of our industry. With curiosity, inventiveness, and entrepreneurial spirit, we keep finding new and better ways to deliver results  for our customers, for our people and for the planet.

Here, you will have the flexibility and empowerment to reimagine the new, spread your wings and see your impact. By doing so, we are motivated to be better together. And together, we will continue to drive and deliver excellence.

Our Values

We take pride in being a people-first company, where our employees feel safe, valued and respected. Our culture values empower us to deliver great results.

With one FedEx culture, we:

Take care of each other | Commit to do good | Own outstanding | Drive business results | Create what's next

Awards

• FedEx has consistently ranked among the top 20 in the World’s Most Admired Companies” report, published in FORTUNE magazine, since 2001
• Ethisphere named FedEx as one of World’s Most Ethical Companies® in 2023

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).

What you can expect

Attractive remuneration package Spread your wings and take ownership of your career with opportunities to advance through internal promotions, job rotations, training and leadership programs and cross-functional project Complimentary 24/7 access to our learning platforms to support you in becoming who you want to be Health & wellness, employee assistance, and rewards and recognition programs Special employee discounts on shipping, travel, and more  

Our Commitment to Equal Opportunities

Our greatest asset at FedEx is our people. We are committed to building a diverse, equitable and inclusive workforce, and offer equal opportunities, fairness and respect to all regardless of who you are. We encourage you to apply even if you feel your experience does not align with all the aspects in the job description as you could be exactly who we need for this or another opportunity.

We do not tolerate discrimination or harassment based on race, color, ethnicity, national origin, religion, sex, age, genetic information, citizenship, disability, marital status, pregnancy, sexual orientation, gender identity, gender expression, veteran status or any other characteristic protected under national, state or local laws. We will reasonably accommodate team members and third parties with physical and mental disabilities.

Interested to join Team FedEx?

Everyone at FedEx has a part to play. It’s about coming up with smart solutions, remaining resilient in the face of setbacks, and going above and beyond to get the job done. And whether you’re a business leader or delivery driver, you’ll be empowered to take responsibility and overcome each challenge in your own way.

If this role and working environment sound like a place you can thrive in, apply today and let’s create what’s next together.

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.