About the position
Our client, a global pharmaceutical company is looking for a Responsible Pharmacist - Supply Operations Quality Manager to join their team. This position is based in Midrand.
The primary purpose of this position is to serve as the Responsible Pharmacist (RP) for the company and to exercise the professional, statutory and regulatory accountability required for the licensed manufacturing pharmacy and legal entity in South Africa. The RP ensures that the company and pharmacy operate in compliance with the Pharmacy Act, 53 of 1974, the Medicines and Related Substances Act, 101 of 1965, applicable regulations, Good Pharmacy Practice, relevant SAHPRA and SAPC requirements, and all conditions and limitations of the licenses held by the company.
In addition, the role provides focused SOQ management support by maintaining effective local product quality systems, coordinating product quality issue management, and overseeing outsourced GMP/GDP activities. These SOQ responsibilities are performed under the direction of the SOQ Sub-Cluster Lead, while the RP retains independent professional judgement and final accountability for matters reserved to the Responsible Pharmacist.
Responsible Pharmacist – statutory, license and legal-entity accountability
Act as registered with the South African Pharmacy Council and formally appointed as Responsible Pharmacist for the company
Exercise personal supervision and independent professional judgement over pharmacy activities and ensure compliance with the Pharmacy Act, Medicines and Related Substances Act, applicable regulations, Good Pharmacy Practice, GDP and relevant SAHPRA/SAPC requirements.
Ensure that the GMP-pharmacy license and SAHPRA license remain valid, accurate, and renewed on time, and that the SAPC and other authorities are informed as required
Ensure operations remain strictly within approved license conditions, including the non-stock-holding premises condition and the authorized import/export scope. Prevent unapproved testing, distribution, material handling, or storage at the licensed premises
Assess proposed changes to the legal entity, premises, responsible personnel, quality systems or licensed activities and ensure required regulatory notifications or prior approvals are obtained before implementation
Act as the official pharmaceutical contact and authorized signatory for SAHPRA, SAPC, the Department of Health and other competent authorities on matters requiring RP accountability.
Oversee and approve regulatory submissions, notifications, responses and commitments involving pharmacy or product-quality compliance, ensuring accuracy and completion within statutory timelines
Represent the legal entity during regulatory inspections and ensure observations; commitments and corrective actions are appropriately addressed and closed
Ensure documented deputy and delegation arrangements provide continuous statutory coverage during RP absence, without transferring the RP’s ultimate professional accountability
Provide professional pharmaceutical guidance to senior management and escalate any activity that may compromise patient safety, product quality, license compliance or the lawful conduct of the pharmacy
Exercise oversight and supervision of the Regulatory, Medical, Pharmacovigilance and other GxP functions for any submission, notification or interaction with the Board of Health (BoH), ensuring that all filings, responses and commitments are accurate, compliant and completed within the required statutory timelines
Responsible Pharmacist – product control and market decisions
Maintain full oversight of medicines imported or exported by the legal entity and confirm that activities comply with product registrations, permits, license conditions and applicable regulatory requirements
Hold final RP decision-making authority for returned medicines, including documented assessment and disposition as return to saleable stock, quarantine or destruction, in accordance with applicable legislation, GDP and company requirements
Authorize or provide required RP approval for product release, quarantine, rejection, destruction, recall, withdrawal and other market actions where pharmacist accountability is required
Ensure medicines are procured, stored, transported, distributed and documented through appropriately authorized third parties under effective quality agreements and RP oversight
Ensure appropriate controls for scheduled medicines, records, traceability and reconciliation, where applicable to the company’s authorized activities
Review and approve promotional, advertising, medical information and related materials or processes where RP review is legally or procedurally required
Ensure suspected quality defects, counterfeit or falsified products and significant compliance risks are promptly escalated, investigated and reported to authorities when required
SOQ Manager – local quality system and product quality support
Implement applicable SOQ procedures and maintain local product quality system aligned with company requirements and South African regulations
Coordinate deviations, product quality complaints, CAPAs, change controls, quality risk assessments, quarantine alerts and local market actions, escalating significant issues to the SOQ Sub-Cluster Lead within required timelines
Monitor key quality metrics and commitments, support periodic quality management reviews, and identify improvement actions
Coordinate required GMP/GDP training and support inspection of readiness, self-inspections and internal audits.
Support the local execution of Area Quality Review Team decisions and provide accurate market information when requested
Third-party quality oversight
Provide risk-based quality oversight of logistics service providers and other GMP/GDP contractors supporting the South African market
Ensure current quality agreements clearly define responsibilities, escalation pathways, RP authority, records access, returns management and regulatory obligations
Participate in contractor qualification, performance reviews, visits or audits as required, and track remediation of identified gaps
Ensure outsourced activities do not limit the RP’s access to information, independent judgement, supervision or final decision-making authority
Governance, collaboration and escalation
Collaborate with Regulatory, Medical, Pharmacovigilance, Supply Chain, Commercial, Legal and other functions while preserving the independence of the RP role.
Escalate significant product quality, patient safety, regulatory or license-compliance risks promptly to the Country President, SOQ Sub-Cluster Lead and relevant governance bodies
Maintain complete, accurate, contemporaneous and inspection-ready records demonstrating RP oversight, approvals and decisions
Ensure data integrity principles are applied to records and systems used for regulated activities
Backup and organizational support
Ensure that appropriate and documented delegation arrangements are implemented whenever the Responsible Pharmacist is absent or unavailable, to maintain continuous coverage of the Responsible Pharmacist activities
Ensure that delegated activities are assigned to an appropriately qualified and authorized individual in accordance with applicable legal and regulatory requirements
KEY PERFORMANCE INDICATORS (KPI)
Maintains license and statutory compliance; completes required regulatory actions on time; ensures timely, documented RP decisions; closes quality commitments within due dates; and performs all duties in accordance with applicable SOPs and work instructions
Works according to relevant GSOP / GWI & Local SOPs
EDUCATION AND EXPERIENCE
Bachelor of Pharmacy (BPharm). Current registration as a pharmacist with the South African Pharmacy Council Eligibility for appointment and registration as Responsible Pharmacist for the legal entity. Advanced qualification in quality, regulatory affairs or business is preferred
At least 10 years of experience in the pharmaceutical or another highly regulated industry, including substantial experience in responsible pharmacist, quality, regulatory, supply or compliance activities. Demonstrated interaction with SAHPRA and/or SAPC is required
Desired Skills:
- Responsible Pharmacist
- SAHPRA
- SAPC
- supply operations
- Bpharm
- CAPA's
Employer & Job Benefits:
- Basic salary
- car allowance
- fuel
- medical aid
- pension
- 13th chq
- performance bonus
