Responsible Pharmacist Deputy - Quality Manager

Fresenius Medical Care North America; Johannesburg; On-site; ZAR 300 000 - 400 000; Full time

Job summary

A leading healthcare company in Johannesburg is seeking a Quality Manager to implement and improve the Quality Management System. Responsibilities include regulatory compliance, acting as Deputy Responsible Pharmacist, and managing training programs. The ideal candidate holds a Bachelor of Pharmacy and has over 3 years of experience in pharmaceutical quality management. Knowledge of SAHPRA regulations and GMP standards is essential for this role.

Qualifications

• 3+ years of experience in pharmaceutical quality management or regulatory compliance.
• Strong knowledge of SAHPRA regulations, Pharmacy Act, GMP, GDP and GxP standards.
• Experience acting as or supporting a Responsible Pharmacist is preferred.

Responsibilities

• Implement and improve local Quality Management System in line with global standards.
• Lead compliance monitoring activities during audits.
• Act as Deputy to the Responsible Pharmacist when required.
• Ensure adherence to product quality compliance throughout distribution.
• Manage training programs for staff on Good Manufacturing Practices.

Skills

Quality Management

Regulatory Compliance

Training & Development

Risk Management

Pharmacovigilance

Education

Bachelor of Pharmacy (BPharm)

Job description

Quality Management System (QMS)

• Implement, maintain, and improve the local QMS in alignment with global and regulatory standards.

• Lead management reviews, internal audits, quality improvement projects, and compliance monitoring activities.

Regulatory Compliance & Inspections

• Ensure full compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), GxP, and Pharmacy Act requirements.

• Support SAHPRA inspections, internal and external audits, including preparation, hosting, and CAPA management.

Deputy Responsible Pharmacist Duties

• Act as Deputy to the Responsible Pharmacist in their absence and assist in the performance of all regulatory responsibilities as defined under the Pharmacy Act.

• Ensure that all activities related to the procurement, storage, handling, distribution, and quality control of pharmaceutical products and medical devices are conducted in accordance with legal and ethical standards.

• Monitor and ensure compliance with conditions of registration, licenses, and permits (e.g., SAHPRA, SAPC).

• Maintain oversight of batch release, recall processes, and documentation as required by the South African regulatory framework.

• Ensure the proper recording and reporting of product complaints and adverse events in collaboration with pharmacovigilance and regulatory teams.

• Liaise with the SAPC and other authorities as needed.

Documentation & Change Control

• Manage SOPs, policies, and other controlled documents. Oversee document lifecycle, archival, and version control as per the corporate guidelines.

• Lead change control processes, ensuring all proposed changes are assessed for quality and compliance impact.

Product Quality Oversight

• Ensure product quality compliance across all stages from receipt to final distribution.

• Review and approve quality records, deviations, non-conformances, and batch documentation.

Supplier & Third-Party Oversight

• Qualify and audit external service providers (e.g., transporters, warehousing, contract labs).

• Ensure suppliers adhere to quality agreements and meet performance expectations.

Management of third-party intermediaries (TPI) acting as distributors for the company in SSA countries:

• Ensure the TPI are operating in accordance with local regulatory requirements and applicable licenses.
• Supervise the compliance with contractual and quality agreements, including product handling, storage, distribution, and documentation standards.

• Undergo regular performance assessments, quality audits, and risk evaluations.

• Report and manage product complaints, deviations, and quality incidents in a timely and compliant manner.

• Ensure clear and effective communication channels between the company and third-party partners to support product quality and patient safety.

• Lead the implementation and periodic review of Quality/Technical Agreements with all third-party distributors.

Training & Development

• Establish and maintain GxP training programs for all relevant staff.

• Ensure personnel involved in the handling of medicines and medical devices are trained and competent.

Quality Risk Management

• Lead quality risk assessments and implement risk mitigation strategies.

• Collaborate with cross-functional teams to proactively address quality concerns.

Pharmacovigilance and Product Recalls

• Support local pharmacovigilance and product recall activities in compliance with regulatory requirements.

• Participate in mock recalls and coordinate timely execution of recall procedures when needed.

Reporting & Communication

• Prepare and communicate quality metrics and reports to management and global quality teams.

• Escalate quality or compliance issues to senior leadership as necessary.

1) Required training and education:

• Bachelor of Pharmacy (BPharm) and registration with the South African Pharmacy Council (SAPC) is mandatory.

2) Required professional experience:

• Minimum 3 years of experience in pharmaceutical quality management or regulatory compliance.
• Strong knowledge of SAHPRA regulations, Pharmacy Act, GMP, GDP, and GxP standards.
• Previous experience acting as or supporting a Responsible Pharmacist is an advantage.
• Familiarity with multinational/matrix environments is preferred.