Are you a Quality focused leader in GMP and GDP, passionate about bringing forward healthcare solutions? If so, AstraZeneca might be the one for you!
ABOUT ASTRAZENECA
AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. Our strategic priorities reflect how we are working to deliver our strategy and achieve our Purpose. As a workforce, we are the catalyst for our values: we are entrepreneurial; we do the right thing; we play to win; we put patients first and we follow the science. As a company we appreciate and take great pride in each team member, where every person is brought together through shared values, that underpin a shared purpose. There’s no better place to feel inspired and energised.
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Join the fastest-growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in International markets. There’s no better place to feel inspired and energized.
ABOUT OUR QUALITY ASSURANCE TEAM
Our Quality Assurance team is highly respected and regarded in the African Cluster and in the global Marketing Company Operations Quality (MCOQ) network. The Cluster, consisting of Sub-Saharan/French-speaking Africa countries and South Africa, is part of the MEA team. We are known for our knowledge and to go the extra mile to get quality products to our patients but at the same time not compromising on Quality Management principles. We know that we cannot fulfil our ambitions alone.
We excel by regular interacting with the other internal departments and having great relationships with our contract distributors. We are part of the global operations quality team to ensure keeping on top of ever-changing requirements or trends ensuring constant development opportunities.
We are part of the local MC GxP network together with the regulatory and patient safety departments. We have the right attitude to go with it. With a “do the right thing” and ongoing communication mindset, we learn from others and ensure we continuously improve the quality management system. Action-oriented, we take calculated risks to make quick decisions but never compromise product quality, safety, or effectiveness.
What you will do
You will be managing the Quality Assurance Team for the African cluster countries who in turn is part of the MEA region MCOQ. You will be a critical player in ensuring the success of the African cluster MCOQ by managing the Quality Management System.
Typical accountabilities will include
Responsible for overseeing the implementation and delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company for all AZ product portfolio in South Africa (SA), Sub-Saharan Africa (SSA), French Speaking Africa (SSA) Marketing Company (MC).
Executes country strategy for Affiliate Quality and Marketing Company GMP/GDP aligned with AZ’s 2030 bold ambition strategy for market expansion, product launches and accessibility.
Accountable for assurance of quality compliance with worldwide standards for all local GMP & GDP activities and connects the affiliate offices the broader Operations Quality and R&D organisation operating under One AZ QMS.
Accountable for compliance with all relevant Acts and Regulations.
Job Description
For South Africa, develop, support and drive excellence in Affiliate GMP&GDP Quality activities to maintain the local License to Operate.
Primary point of GMP&GDP contact for the country and maintaining an effective governance structure to ensure oversight of quality activities.
Responsible for QMS implementation in SA and SSA & FSA MC.
Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities in the SA/SSA/FSA MC.
Responsible for the coordination of Quality Management reviews across GxP functions for South Africa and SSA&FSA MC.
Represents Quality on cross-functional and cross SET teams and steering committees related to Affiliate market.
Drive global standardisation, simplification and improvement of South Africa and SSA&FSA Quality Management processes.
Provide training, supporting and coaching structure for Quality roles.
Is the primary point of expertise for GMP & GDP activities impacting the South Africa and SSA&FSA MC organizations.
Responsible for budget planning and adherence to budget for the Country, South Africa & SSA& FSA MC.
Responsible for promoting Quality Culture across AstraZeneca South Africa and SSA&FSA MC organizations.
Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Affiliate GxPs within the MC.
Accountable for compliance to Country specific quality and regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batches, resolution of Issue Management, recalls, influence decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ licence to operate.
Demonstrated ability to work independently and in project settings to deliver objectives.
Keeps own knowledge of best practices, industry standards and new developments in quality management up to date.
Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations.
Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Distribution Practice and regulatory requirements of own work and others work.
Responsible for ensuring that policies and standards meet regulatory requirements.
Carries out compliance reviews and reporting for external suppliers including issue resolution with senior management and AZ site/MC leaders, this may include, but is not limited to, the review and approval of investigation reports and participation in issue management teams.
Supports local SA, SSA & FSA MC to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation of effective self-assessment programs.
Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
Contributes to development local procedures due to specific local regulatory requirements and provides some technical input into the development of global procedures and standards.
Proactively looks for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring appropriate level of compliance
If this sounds appealing, please read on to understand the experience and skills we’re looking for…
ESSENTIAL SKILLS & EXPERIENCE REQUIRED
Completed Bachelor of Pharmacy Degree and registration with the South African Pharmacy Council
Minimum 5 years’ experience as Responsible Pharmacist
Appropriate cross functional collation with key stakeholders at the MC-Regulatory/Patient Safety/Medical Information/ Key Account Managers/ Marketing/ Supply/ QA Pharmacist
Appropriate cross functional collation with Ops Distribution Country Leadership Team
Strong communication and influencing skills with accuracy and attention to detail
Project and people management
Fluency in English is required.
Must be open to travel when necessary.
Why AstraZeneca?
AstraZeneca recognized as Top Employer | South Africa, Kenya & Nigeria 2025. Best Place to Work in Ivory Coast, Senegal, Cameroon, Ghana & Ethiopia 2024 – 2025.
Furthermore, we are proud to have achieved the impressive feat of ranking second place in the Best Places to Work for the second consecutive year running in Africa. This distinction is a confirmation of our commitment and ability to sustain people, partnerships, and employee engagement and foster an innovative workplace environment.
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. Join the fastest-growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in International markets. There’s no better place to feel inspired and energized.
SO, WHAT’S NEXT?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
Click the link to apply no later than 08 July 2025 and we’ll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Close Date: 08/07/2025
Date Posted
01-Jul-2025Closing Date
08-Jul-2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
