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Director Quality Management, Late Development Oncology Clinical Operations

Hybrid in Barcelona·Full-time·Added 2 days ago (last checked 14 Nov)

AstraZeneca

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Our summary

Work mode: Hybrid, Barcelona
Contract: Full-time
English: Required
Experience: 10+ years
Education: University degree

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Skills

Requirements

What we're looking for

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.

The role

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.

What you'll do

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.

How you'll work

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Date Posted

13-nov-2026

Closing Date

26-nov-2026

Hiring process

2 steps1 interviewa task to do

Application
Recruiter contact · With a recruiter
Assessment
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Some roles, especially graduate roles, add a game-based assessment, a video or telephone interview, or an assessment day.
Interview
A two-way conversation about your skills and suitability for the role, and a chance for you to find out if AstraZeneca is right for you.
Pre-employment screening
Offer

Candidates who reach interview stage or beyond usually get feedback within 14 days of the role's closing date.
Interview travel expenses are reimbursed for journeys over 100km.
Alcohol and drug testing is carried out for new hires where required by local country legislation.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that discovers, develops, and commercializes prescription medicines in therapeutic areas including oncology, cardiovascular, renal and metabolism, and respiratory and immunology. With a workforce of over 80,000 employees worldwide, the company is headquartered in Cambridge, UK, and operates across more than 100 countries, focusing on innovative medicines and advanced technologies like AI and data science to transform patient care.

In Spain, AstraZeneca has a significant presence with offices in Madrid and Barcelona, contributing to clinical development, regulatory affairs, and commercial operations. The company is known for its collaborative and inclusive culture, offering international professionals opportunities to work on global projects, particularly in areas like cell therapy, AI-driven health solutions (Evinova), and patient safety. With a strong commitment to diversity and innovation, AstraZeneca Spain is an attractive destination for talent seeking to make a global impact while living in Spain.

Industry: Pharma
Founded: 1999
Employees: 10,000+
Headquarters: Cambridge, UK
In Spain: Madrid, Barcelona

Good to know if you are moving

AstraZeneca offers a global, multicultural work environment with opportunities to collaborate with colleagues across the world.
The company has a strong commitment to employee development and offers various career growth programs.
Spain offices are located in major cities like Madrid and Barcelona, offering a high quality of life and vibrant culture.
AstraZeneca is a leader in innovative therapies, providing employees with the chance to work on cutting-edge medical advancements.
The company supports flexible working arrangements and promotes a healthy work-life balance.

In their own words

Additional information

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.

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