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. This Job description applies to both senior and non-senior role levels with additional responsibilities and expectations applicable for the senior role, defined in document ‘Site Management and Monitoring (SM&M) Biopharmaceuticals Senior Role Definition’

Responsibilities

Accountabilities for this role include: Advise Local Study Teams on AstraZeneca procedural frameworks, international guidelines such as ICHGCP, 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.

Requirements

Education

and experience: Bachelor’s 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. 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. Date Posted 05-sie-2026 Closing Date 12-sie-2026 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are 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, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.