Hc Quality And Regulatory Advisor

Fedex Express; Johannesburg; On-site; ZAR 60 000 - 90 000; Full time

Job summary

A global logistics company in Johannesburg is seeking a HC Quality and Regulatory Advisor. This role is crucial in ensuring compliance with healthcare quality standards and regulations. Responsibilities include developing quality processes, acting as the primary liaison for healthcare customers, and leading audits. The ideal candidate will hold a Master's or Bachelor's degree in Pharmacy and have 5-8 years of relevant experience in quality compliance within the pharmaceutical or healthcare sector. Strong presentation and communication skills are essential.

Qualifications

• 5-8 years of relevant experience in pharmaceutical or healthcare industry in a quality compliance role.
• Good knowledge of GDP/GMP, WHO and IATA CEIV desirable.
• Experience in leading customer and supplier audits.

Responsibilities

• Ensure organizational compliance with healthcare standards and regulations.
• Develop and implement quality processes across FedEx network.
• Act as primary contact for healthcare customers on regulatory matters.

Skills

Strong presentation skills

Influencing and negotiating

Problem solving

Detail-oriented

Planning and organizing

Communication (written and verbal)

Education

Masters / Bachelor's degree in Pharmacy or equivalent

Tools

Microsoft Office

Job description

Job title : HC Quality and Regulatory Advisor

Location: Gauteng, Johannesburg

Deadline: December 20

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 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 within 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 :

Pharmaceutical jobs