HC Quality and Regulatory Advisor

Overview

Title – Healthcare Quality & Regulatory Compliance Advisor

Department - Quality

Number of positions - 1

Location :
Johannesburg, South Africa

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 and global customers, ensuring that Fed Ex network facilities—including hubs, gateways and stations—operate in full compliance with healthcare quality requirements and regulatory expectations.

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

• Strong presentation skills; proven ability to influence, persuade, negotiate and make decisions.
• Strong written and verbal communication.
• Comfortable networking with colleagues globally.
• Microsoft Office skills; accuracy and attention to detail.
• Proven problem solving, planning and organizing abilities.
• Language:
  English proficiency.
• Certifications and Licenses:
  Local Pharmacist license highly preferred, or 5-8 years of experience in Healthcare Quality in a multinational healthcare company.

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.…