Senior Specialist, External Quality

Introduction to role: Are you ready to ensure every technical transfer milestone delivers safe, compliant, and reliable outcomes that reach patients faster? Step into a pivotal role where your quality leadership drives right-first-time manufacturing at contract partners and accelerates the journey from development to commercial supply. You will join a highly collaborative network of development, clinical supply, and external manufacturing teams working to bring complex biologics to life. Your expertise will align critical process parameters and quality attributes, shape risk-based decisions, and translate data into action. Can you picture yourself being the voice of quality at the table, guiding CMOs through engineering and PPQ runs, and turning insights into sustainable improvements? Accountabilities: - Quality Leadership: Serve as the quality lead with Product Development/Clinical Supply (PDCS) teams, External Manufacturing and Operations (EM&O), and key stakeholders to ensure on-time delivery of technical transfer projects and robust GMP outcomes. - GMP Oversight: Provide oversight of GMP systems executed by CMOs and the External Supply Chain for Drug Substance and Drug Product to maintain consistent compliance and readiness for clinical and commercial supply. - CMO Documentation Compliance: Review contractor documents, including batch records, deviations, and change controls, to verify alignment with procedures and standards; track and drive effective implementation to closure. - GxP Guidance: Guide ongoing document reviews and approvals and provide pragmatic GxP advice aligned to current guidelines and regulations, embedding quality by design principles. - SOP and Audit Support: Approve organization-specific SOPs and controlled documents issued by CMOs; support audits and pre-approval inspections to sustain inspection readiness and regulatory confidence. - Metrics and Continuous Improvement: Develop and issue quality metrics for technical transfer activities; use these insights to prioritize process improvements and strengthen risk control. - Transfer Performance Insight: Trend and analyze quality aspects of technology transfers to measure KPIs, identify opportunities for continuous improvement and risk mitigation, and propose and lead implementation of CAPAs. - Deviation and Risk Management: Review and assess deviations, perform risk assessments, participate in root cause analyses, and ensure timely tracking, follow-up, reporting, and trending to prevent recurrence. - QA Project Support: Support QA in guiding projects and technical meetings; document and report compliance issues to management with clarity and impact. - Coaching and Enablement: Mentor early-career team members on quality processes, digital tools, and compliance requirements to elevate team capability and consistency. Essential Skills/Experience: • . degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry. • >5 years’ cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial technology transfers. • Experience providing QA oversight across end-to-end technical transfers for biologics—reviewing/approving transfer plans and protocols, ensuring CPPs/CQAs are aligned and compliant. Supporting engineering and PPQ runs including associated deviations, CAPA, and change controls. • Understanding of pharmaceutical bulk and drug product development and manufacturing. • Experience working with contract manufacturing/laboratory organisations essential. • Knowledge of quality management systems and regulatory requirements. • Demonstrated ability to understand and solve complex scenarios, and make appropriate, risk-based decisions. • Proven ability to collaborate effectively and sensitively across all levels of the organization, including senior leadership and external partners. • Demonstrated success leading high impact business cases, implementing significant change management programs, and applying technical expertise to complex problems. • Has the ability to interpret and advise on quality standards to build quality in process, monitor performance and seek opportunities for continuous improvement. • Able to look at a variety of data sets with a critical lens and draw out more meaningful insights that are not so obvious. • Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment. • Flexibility to travel in support of the role. Desirable Skills/Experience: • Experience in working with Contract manufacturing Organisations. • Experience in working with Clinical Molecules . • Excellent communication and interpersonal skills • Experience in working with FDA, EMA, HPRA and PMDA regulated industries • Demonstrated ability in decision making, problem solving and project management. Why AstraZeneca: Here, patient need sets the pace and quality is central to how we deliver. You will work in an environment that blends the agility of a biotech with the scale and science of a global biopharma, where diverse perspectives come together to solve tough problems. We bring unexpected teams into the same room to spark bold thinking, pair ambition with kindness, and stay close to the lived experiences of people with rare and devastating diseases. Your judgment, integrity, and curiosity will be backed by modern tools, deep technical expertise, and leaders who invest in your growth—so the improvements you drive show up where they matter most: in medicines that change lives. Call to Action: If you are ready to lead external quality with purpose and transform complex transfers into consistent, compliant supply, send your CV and take your next step toward making a measurable difference for patients. Date Posted 09-Sep-2026 Closing Date 22-Sep-2026 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.