Clinical Quality Associate Director

Do you have expertise in and passion for science working in the Clinical Team creating value for our patients If so AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global global science-led patient-focused Biopharmaceutical business that focuses on the discovery development and commercialization of prescription medicines for some of the worlds most serious diseases. But we are more than one of the worlds leading pharmaceutical companies. At AstraZeneca we are dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There is 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 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 underpins a shared purpose. There is no better place to feel inspired and energised. Answer unmet medical needs by pioneering the next wave of science focusing on outcomes and crafting the patient ecosystem.

At AstraZeneca were 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. Theres no better place to feel inspired and energized.

ABOUT THE CLINICAL TEAM

You will join a collaborative patient-focused team driving high-quality clinical research with scientific rigor operational excellence and meaningful impact across South Africa.

What You will do

The Clinical Quality Associate Director (CQAD) is primarily responsible for maintaining developing and communicating high-quality standards in the delivery of clinical studies. This includes playing a central role in coordinating and meeting the training needs of the local Site Management & Monitoring (SMM) team through close collaboration with local SMM leadership and reporting to Director Country Head.
This role acts as the primary advisor on compliance and process matters within the local SMM team proactively identifying and pursuing opportunities to drive quality and process improvements at local regional and global levels.
A key aspect of the role is the development implementation and continuous oversight of local procedural documents as well as ensuring up-to-date knowledge of local regulations and industry practices pertaining to clinical trials. The CQAD supports audit and inspection activities serving as the primary point of contact for auditors and inspectors in their local SMM organization.
Working collaboratively with the local SMM leadership team the CQAD assists in planning and executing all quality control activities and applies robust risk management principles to assess compliance issues and implement effective solutions. The CQAD stays informed about business compliance matters working closely with the Regional Director Clinical Quality (RDCQ) and actively engaging with key regional and global networks.

Accountabilities for this role include:

• Advise Local Study Teams on AstraZeneca procedural frameworks international guidelines such as ICH-GCP industry standards and relevant local regulations.

• Provide accurate and timely updates on local clinical trial regulations ensuring teams are aware of any changes affecting compliance.

• Support local management in planning and executing Quality Control (QC) activities as outlined in the local QC plan.

• Offer expert guidance and support to local management in addressing and resolving quality-specific concerns at the local level.

• Assist local teams with audit and regulatory inspection preparation execution and response activities ensuring readiness and effective follow-up.

• Advise Local Study Teams on resolving audit and inspection findings and assists with implementing corrective actions.

• Facilitate knowledge sharing by communicating audit and inspection learnings to local staff and the regional CQAD network as well as cascading global/regional insights on the local level.

• Oversee country-level risk management identifying and supporting mitigation actions to address compliance risks.

• Serve as a key contact in the evaluation and management of fraud or misconduct cases liaising with Quality Assurance the Regional Director Clinical Quality (RDCQ) and local management as needed.

• Identify ongoing and ad hoc training needs for local staff and coordinate or deliver training in collaboration with local SMM leadership.

• Support the local implementation of global procedures and systems by providing feedback on procedural documents delivering local training as required and collecting and escalating user questions and issues liaising with local subject matter expert if applicable.

• Lead or contribute to the implementation of systems and tools for delivering clinical operational tasks SOPs and ICH-GCP requirements at the local level.

• Oversee development maintenance training and archiving of Local Procedural Documents ensuring alignment with global processes ICH-GCP and local regulations.

• Act as the primary local interface for Quality Assurance.

• Actively participate in the Clinical Quality Associate Directors Network at the regional level contributing to shared goals and best practices.

• Represent the organization in local regulatory or operational expert groups as required.

• Provide expert opinions on local regulations related to clinical trials when requested by other departments.

• Deliver training to investigational site staff on ICH-GCP and local regulations when additional support is needed.

• Responsibility to promptly collect and report any adverse events and product quality complaints received from any source. All such cases must be documented accurately and submitted to the designated department within one business day of becoming aware of the information ensuring compliance with company policies and applicable regulatory requirements.
• Responsibility to complete Adverse Event training during initial onboarding and then annually thereafter.

If this sounds appealing please read on to understand the experience and skills were looking for

ESSENTIAL SKILLS AND EXPERIENCE REQUIRED

• Completed Bachelors degree in related discipline preferably in life science or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders.

• Must have 5 years experience in a pharma clinical research environment

• Previous experience in the pharmaceutical industry preferably in Clinical Operations/Quality Assurance.

• Relevant knowledge and ability to fulfil key responsibilities including but not limited to:

• Drug development process and related GxP processes International guidelines ICH-GCP relevant country regulations medical knowledge and ability to learn relevant AZ Therapeutic Areas Clinical Study Management including monitoring study drug handling and data management.

• Personal Effectiveness & Drives Accountability in Others

• Learning Agility

• Financial Technology & Process Competency

• Active Listening Fluency in written & spoken business-level English

• Act with Integrity & high ethical standards

• Effectively lead a team across in-person and virtual settings to deliver shared goals demonstrates cultural awareness

• Identify and champion more efficient delivery of quality clinical trials with optimised cost and time

• Ability to travel nationally/internationally as required

• Valid driving license if country employment requirement

• Communication & Teamwork Influencing Training & workshop facilitation

• Effective risk-based thinking Problem Solving Critical Thinking Decision Making Strategic Thinking Effective Issue Management

• Clinical Study Operations (GCP) & Quality Management - Audit & Inspection Readiness Process Management & Improvement

• Leadership Enable Change Feedforward & Coaching.

Why AstraZeneca

We are proud to have achieved Top Employer certification in South Africa Kenya and Nigeria for 2026. 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 were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were 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. Theres no better place to feel inspired and energized.

SO WHATS NEXT

Are you already imagining yourself joining our team Good because we cant wait to hear from you!

Click the link to apply no later than 10 June 2026 and well be in touch as soon as we can.

WHERE CAN I FIND OUT MORE

Our social media Follow AstraZeneca on LinkedIn AstraZeneca on Facebook Date: 10/06/2026

Date Posted

Closing Date

AstraZeneca 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.