Product Quality Lead

This is what you will do:

· The Product Quality Lead (PQL) is responsible to provide product quality stewardship of our products from introduction throughout the lifecycle. As the scientific quality expert, the PQL will own the strategy to proactively minimize product quality risks through early detection and mitigation during product development, technology transfer, commercial operations, and product discontinuation. The PQL is the Quality liaison between Regulatory Affairs and Operations to ensure regulatory compliance of manufacturing and testing processes. The role enables efficient communication and decision making related to the quality of our products.

You will be responsible for:

· Lead / oversee specific processes and assigned aspects of the scientific quality management related to Alexion commercial and late stage clinical products at a regional level.

· Proactively manage product quality risks ensuring they are proactively mitigated, actioned, and escalated to senior management. Drive systemic approaches to enable regulatory compliance and address complex issues.

· Provide lead quality CMC review of regulatory submissions and response to queries. Facilitates management and closure of post marketing regulatory commitments. Demonstrated ability to interpret implications of changing regulatory aspects on own area and guide teams around regulatory documentation, applications, and review.

· Act as CMC Quality point of contact with global program strategy teams for technical issues in own scientific area (e.g. product specifications, reference standards, stability criteria, product / devices, tech transfer, GMP manufacturing, analytical methods) to ensure consistent quality approach to GMP manufacturing, testing, release, and regulatory filings.

· Provide technical guidance and inputs to cross-functional teams and leadership to influence alignment and CMC regulatory compliance.

· Author Global Annual Product Quality Reports, coordinating with leads of contributing chapters, and manages commitments to closure. Analyse, interpret, and communicate data trends and observed deficiencies in product quality; provide recommendations to address such developing trends in a proactive manner.

· Oversee initiatives to improve performance and process robustness within own scientific quality area. Proactively look for opportunities to identify and manage change and enable adoption of emerging technologies and industry practices.

· May liaise directly with local, regional, and global senior management, where necessary, to ensure issues are understood and proposed actions are acceptable.

· Communicate with regulatory agencies and / or industry / professional organisations, as applicable, to build awareness of trends, digital technologies, and initiatives in scientific quality area.

· Plan, coordinate, and implement scientific quality systems, approaches, and standards in collaboration with relevant teams.

· Maintain Product Quality Monographs and Supply Chain Maps in compliance with commercial marketing applications and investigational products

· Primary Quality oversight of product specifications and reference standard program with a focus on ensuring supply

· Lead Stability Review Boards to enable primary Quality oversight of the stability program including ensuring annual commitments are met.

· Support process lifecycle and analytical lifecycle management initiatives. Facilitate global changes with respect to the product

· Partner with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, BPDRs, recalls, etc.

· Energize and empower teams to effectively explore new digital solutions and practices that drive business value. Leads successful adoption of digital tools and best practices through ongoing learning and structured approaches.

· Apply knowledge of key regulations when authoring, reviewing and / or approving technical documentation.

· Provides support where needed in the creation of Quality Target Product Profiles and product characterization and comparability assessments in line with regulatory expectations

· Supports Health Authority inspections and compliance

You will need to have:

· 10 years cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment

· B.S / B.A. degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry

We would prefer for you to have:

· Previous experience in product lifecycle management, including pre-clinical to commercial phases

Date Posted

15-Dec-2025

Closing Date

04-Jan-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.