Responsible Pharmacist - Supply Operations Quality Manager at Pfizer

• The primary purpose of this position is to serve as the Responsible Pharmacist (RP) for Pfizer Laboratories (Pty) Ltd 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 Pfizer Laboratories (Pty) Ltd.
• 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 Pfizer 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 Pfizer 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.

QUALIFICATIONS

• Level of Education : Bachelor of Pharmacy (BPharm) or equivalent qualification recognized in South Africa. 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
• Experience : 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.
• Languages : English
• Computer skills : Microsoft Office – SAP - Copilot

COMPETENCIES – PERSONAL CAPABILITIES

Technical skills

• Comprehensive knowledge of the Pharmacy Act, Medicines and Related Substances Act, Good Pharmacy Practice, GDP, applicable SAHPRA/SAPC requirements, and pharmaceutical quality principles.
• Strong experience with license compliance, responsible pharmacist oversight and quality systems, including deviations, complaints, CAPAs, change control, documentation, audits and inspections.
• Able to work and contribute effectively to cross-functional teams, culture differences, and diversity.
• Able to exercise independent professional judgement and make sound, risk-based decisions in complex or ambiguous situations.
• Has analytical skills.
• Has effective communication skills with internal and external business partners.
• Strong technical writing and presentation skills.
• Strong planning and organizing skills.

Soft skills / Management & Leadership Skills

• Acts decisively and escalate regulatory, patient-safety and product-quality risks appropriately.
• Demonstrates continuous learning and professional development.
• Self-motivated, professionally independent, and confident influencing cross-functional stakeholders.
• Holds self and others accountable for compliant execution.
• Has high self-awareness.
• Has a positive influence on others.
• Demonstrates integrity, courage, sound judgement, and emotional intelligence.