Qualified Person (Clinical), External Quality Operations

Introduction to role:Are you ready to use your Qualified Person judgement to accelerate clinical trials and bring life-changing medicines closer to patients with rare and devastating diseases? In this Dublin-based role, you will be the certifying authority for investigational medicinal products across biologics, small molecules, and polypeptides used in EU/EEA clinical trials, ensuring every batch released is safe, compliant, and ready when patients and investigators need it.

You will join a fast-moving, collaborative quality team working at the intersection of development, regulatory, and technical operations. From day one, you will build the evidence base and make independent, risk-based certification decisions aligned with EU GMP Part I, Annexes 13 and 16, and the Clinical Trials Regulation (EU) No 536/2014. Can you see yourself balancing speed and rigor to keep trials on track? Do you want your decisions to directly safeguard subjects and sustain trial integrity across Europe?

Accountabilities:- Batch Certification (DS and DP): Lead QP review of batch records, analytical results, deviations/OOS/OOT, change controls, and validation status; confirm compliance with IMPD/CTA and approved specifications; certify DS and DP within the scope of authorization and Annex 16 to enable on-time clinical supply.- Product Specification Files: Maintain complete and current PSFs for DS and DP, ensuring specifications, processing instructions, methods, sampling plans, and storage conditions are controlled and synchronized with batch records and release criteria.- Regulatory and Authorization Conformity: Verify manufacture and testing are performed at authorized sites and within CTA/IMPD scope; ensure substantial amendments are reflected before certification.- Quality Risk Management: Apply ICH Q9 to assess deviations, excursions, and changes; document clear benefit-risk justifications that protect subject safety and data reliability while avoiding unnecessary supply delays.- Stability Oversight: Review stability commitments, trends, and data to confirm continued suitability for clinical use and to inform shelf-life decisions.- Importation and QP Declarations: For non-EU manufacture, confirm availability and adequacy of QP declarations and supporting evidence (GMP equivalence, audit status, traceability) before certification.- Distribution Readiness: Ensure validated lanes, approved storage/transport conditions, and robust temperature excursion management are in place to maintain product quality through to investigator sites.- Issue Management and Disposition: Lead or approve investigations and CAPAs related to certification; make decisive, well-rationalized dispositions (certify, certify with conditions, quarantine, reject) and communicate outcomes to Supply Chain and Clinical Operations.- Inspection Readiness and Representation: Maintain complete, inspection-ready certification records and rationales; confidently represent QP decisions during internal and authority inspections.- Cross-Functional Collaboration: Partner with development, regulatory CMC, and technical services to resolve issues arising from record reviews and deviations in a timely, risk-based manner.- Contractor Oversight: Review external manufacturer documentation (batch records, deviations, change controls) for compliance with procedures and standards; influence partners to meet expectations.- QA Project Leadership: Support and guide quality projects and technical meetings, driving closure and embedding best practices.- Compliance Reporting: Document and escalate compliance issues to management with clarity and urgency.

Essential Skills/Experience:- Must be a Qualified Person as defined under EU GMP.- Minimum 5+ years’ experience in DS/DP/FP manufacturing processes in a cGMP environment, including technology transfers.- Knowledge of industry best practices and current regulatory expectations concerning DS and DP manufacturing.- Experience working with contract manufacturing organisations.- Working knowledge of EU GMP Part I and Annexes 13 and 16; willingness to rapidly deepen clinical QP expertise.- Ability to provide project leadership and guide successful completion of quality projects.- Excellent written and verbal communication and negotiation skills.- Proficient in risk assessment and risk management.- Ability to exercise sound judgment within defined procedures and practices to determine appropriate action.- Ability to prioritize to meet internal and external customer needs within established timelines in a fastpaced environment.- Ability to monitor and report on assigned tasks, goals, and objectives.- Ability to operate effectively in a complex matrix organization and international environment.- Strong, mature leadership and interpersonal influencing skills.- Proficient with SAP and Veeva Vault.- Bachelor’s degree required; preference for candidates with advanced degrees. Five or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.- Must have Qualified Person qualification as defined under EU GMP.

Desirable Skills/Experience:- Hands-on certification experience for investigational medicinal products across biologics, small molecules, and polypeptides.- Deep familiarity with the Clinical Trials Regulation (EU) No 536/2014 and practical application of Annex 13 and Annex 16 to IMP release.- Experience managing PSFs and aligning them with master batch records and release testing strategies.- Direct engagement with EU authority inspections (e.g., HPRA) and successful defense of certification rationales.- Expertise in importation pathways, QP declarations, and equivalence of non-EU GMP systems.- Knowledge of stability program design and evaluation for clinical supplies and temperature-controlled logistics.- Proven effectiveness in multi-partner CMO/CLO networks and complex tech transfer environments.- Comfort with data trending/analytics tools to support evidence-based certification and risk decisions.

Why AstraZeneca:Join a rare disease-focused organization within AstraZeneca where your expertise has immediate, visible impact on patients and on the success of our clinical portfolio. You will work with people who combine scientific rigor with humility and care—unexpected teams in the same room unleashing bold thinking, yet grounded in the realities of getting medicines to those who need them. We invest in your growth with challenging work, supportive leaders, and opportunities to master complex problems, and we value kindness alongside ambition so you can make brave decisions that keep trials moving and patients safe.

Call to Action:Step into a role where your certification decisions unlock clinical progress—bring your QP judgement to Dublin and help us deliver urgently needed medicines faster!

Date Posted

21-Jul-2026

Closing Date

31-Jul-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.