Introduction to role:

This role focuses on Qualified Person responsibilities for investigational medicinal products, with an emphasis on QP release of a range of products (Biologics/Small Molecule/Polypeptides) used in EU/EEA clinical trials. The position is suited to a qualified/eligible QP who may be early in their career with previous QA clinical experience. You will build the evidence base and exercise independent, risk‑based judgement to certify DS and DP in accordance with EU GMP (Part I), Annex 13 and Annex 16, and the Clinical Trials Regulation (EU) No 536/2014.

Accountabilities

Batch certification (DS and DP): Conduct QP review of batch documentation, analytical results, deviations/OOS/OOT, change controls, and validation status; confirm compliance with the IMPD/CTA, approved specifications, and technical instructions; certify DS and DP batches for clinical use within scope of authorisation as laid down in EU GMP and in accordance with Annex 16.
Product Specification File (PSF) approval: Ensure up‑to‑date DS and DP PSF content (specifications, processing instructions, analytical methods, sampling plans, shelf‑life/storage conditions) are maintained; ensure PSF changes are controlled and synchronised with batch records and release criteria.
Regulatory and authorization conformity: Verify that manufacture/testing are performed at authorised sites and within the scope of the CTA/IMPD and substantial amendments.
Quality risk management: Apply ICH Q9 to assess the impact of deviations, excursions, unplanned events, or process/analytical changes on subject safety, trial integrity, and data reliability; document benefit‑risk justifications supporting certification or rejection
Stability: Review stability commitments and trending
Importation and QP declarations: For non‑EU manufacture, verify availability and suitability of QP declarations and supporting evidence (GMP equivalence, audit status, traceability) prior to certification
Distribution readiness: Confirm that approved storage/transport conditions, validated lanes, and temperature excursion management are in place prior to certification
Issue management and disposition: Lead or approve investigations and CAPAs relevant to batch certification; make clear, documented disposition decisions (certify, certify with conditions, quarantine, or reject) and communicate outcomes to Supply Chain and Clinical Operations.
Inspection readiness and representation: Maintain certification records and rationales to an inspection‑ready standard; represent QP decisions in internal and authority inspections
Collaborate with internal cross‑functional areas (PDCS, CMC/Regulatory Affairs, and Technical Services) to resolve issues in a timely manner resulting from record reviews and deviation events.
Review contractor documents (e.g., batch records, deviations, and change controls) to ensure compliance with Alexion procedures and standards.
Support Quality Assurance in guiding various projects and technical meetings, as needed.
Document and report compliance issues to management.

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 fast‑paced 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.

Why AstraZeneca:

Here your quality judgment will carry real weight, shaping how life-changing therapies reach people living with rare and serious conditions. You will join a collaborative, courageous culture that blends the agility of biotech with the reach of a global science leader, where unexpected teams sit around the same table to solve tough problems quickly. We stay close to patients and to each other, valuing kindness alongside ambition, and we invest in your growth so you can stretch your expertise while making a measurable difference to studies that cannot wait.

Call to Action:

If you are ready to use your QP expertise to unlock safe, rapid access to clinical therapies that matter, send us your resume and take the next step in impact.

Date Posted

26-Feb-2026

Closing Date

11-Mar-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.

Qualified Person (Clinical), External Quality Operations

Job Description