Location: Barcelona - Spain (3 days working from the office and 2 days working from home)
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide.Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. At the heart of AstraZeneca, our team is committed and encouraged to follow the science. Driven by our curiosity, passion, and determination, we are paving the way to change the practice of medicine in Oncology. The Oncology Clinical Quality Director (O-CQD) will be responsible for the management and oversight of the LDO Quality Associate Directors.
Typical Accountabilities
Build strong relationships and strategic partnerships; collaborate proactively across functions and HUBs to drive adherence to compliance requirements while operating effectively in ambiguity.
Lead, develop, and coach a geographically and culturally diverse team of quality professionals.
Embed quality frameworks, risk management approaches, and compliance strategy with senior leadership and employees.
Interpret complex data to assess quality performance and recommend compliance improvements and risk mitigations across LDO Clinical Operations.
Provide expert quality advice and coaching to direct reports and LDO ClinOps teams on complex compliance matters, including risk identification and compliance improvement strategies, initiatives, and plans.
Support LDO ClinOps teams in driving a quality mindset and culture, including resolution of sophisticated quality matters (e.g., serious breaches, fraud, poor quality).
Lead Quality Management Reviews by consolidating and strategically communicating key compliance-relevant insights on country/regional and functional performance to enable continuous improvement.
Seek, engage, and lead compliance collaborations across LDO ClinOps, and other R&D Functions to deliver effective, sustainable issue resolution.
Identify and consolidate LDO clinops/country/regional and HUB risks; escalate as required; define, support, and lead (as appropriate) risk mitigation (compliance) activities end-to-end.
Advise on AZ procedural framework (global clinical processes, procedural documents, Quality & Compliance manual) and applicable guidelines/standards and local regulations (including ICH-GCP).
Provide senior-level advice on local and/or international clinical trial regulations; remain current on changes and ensure teams/processes are updated accordingly.
Share learnings from audits and inspections with LDO clinops employees; cascade global /regional learnings across local, regional, and global stakeholders.
Act as the interface with global stakeholders (e.g., legal advice, ethics, nominated signatory, GxP function) for quality-related topics.
Represent the function in external expert groups (regulatory or operational) as required.
Crucial Requirements
Bachelor’s or advanced degree required in a science related field.
Approximately 10 years demonstrating excellent knowledge of international regulations and guidelines; deep experience engaging global regulators (FDA, PMDA, EMEA, Health Canada), including inspection conduct in the clinical research industry.
Significant clinical research quality and compliance experience; deep knowledge of ICH-GCP and applicability to clinical operations at both sponsor and site levels.
Strong understanding of the drug development process and related GxP activities, including successful clinical study delivery (e.g., ICH-GCP, study management).
Broad experience in the pharmaceutical industry within a GxP-regulated environment.
Proven leadership and line management skills that helps teams excel in a regulated environment.
Excellent communication skills with a proven track record of effective cross-functional and global networking.
Strong critical thinking and risk-based decision-making skills.
Effective analytical, problem-solving, negotiation, and conflict resolution skills.
Demonstrated ability to set and manage priorities, performance targets, and project initiatives in a global environment.
Ability to collaborate proactively, operate effectively in ambiguity, and build strong customer relationships/strategic partnerships to enable process and system harmonization/standardization.
Date Posted
13-nov-2026
Closing Date
26-nov-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.
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