Responsible Pharmacist - Supply Operations Quality Manager
- South Africa - Sandton
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.
1.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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Quality Assurance and ControlBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
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