Associate Director, Quality Control

This is what you will do:

The management and oversight of the following QC activities: analytical, microbiological; sample management; direct laboratory testing support; equipment management & maintenance support to ensure fully compliant, effective and safe Quality Control laboratories. The compliance and inspection readiness of all Quality Control activities on site and in line with regulatory and quality standards related to the testing of Alexion products per respective licensed specifications, as well as technical support of new products, registrations, filings.

Lead and support QC forums and provide technical expertise in support of the Alexion Athlone operational functions & network.

You will be responsible for:

· Provide leadership and oversight to the QC laboratory functions, ensuring the full application, implementation, and adherence to current testing standards as well as EHS standards, maintaining effective, compliant, and safe QC laboratories in accordance with GMP and EAEU requirements.

· Accountable for review, approval, or rejection of all raw materials, packaging materials, intermediates, bulk, and finished products, by ensuring these meet approved specifications and quality standards before release, use, or distribution.

· Accountable for review and approval of all QC-related specifications, sampling procedures, test methods, instructions, and procedures, ensuring their suitability, relevance, and regulatory compliance prior to implementation or update.

· Ensure the establishment, validation/qualification, calibration, and routine maintenance of all QC equipment and laboratory systems, in accordance with internal and regulatory requirements, to support accurate and reliable testing.

· Oversee and ensure the formal recording, review, evaluation, and retention of all QC test data, guaranteeing data integrity, traceability, and readiness for internal and regulatory audits.

· Monitor and control QC testing processes, ensuring adherence to agreed lead times and compliance with approved methods and specifications.

· Provide QC review and formal approval on relevant QC documentation, as required, to support the release of pharmaceutical materials and products in compliance with regulatory expectations.

· Implement, communicate, and continuously maintain all QC Standards, Procedures, and GMP documentation, ensuring ongoing compliance, continuous improvement, and readiness for inspection.

· Ensure standardized QC practices and systems across all site QC functions and champion the implementation of Operational Excellence principles, including Continuous Improvement and Digital Strategy.

· Represent the QC function at regulatory, corporate, and internal inspections, audits, and quality forums, ensuring all QC-related requirements are understood and demonstrated.

· Oversee the recruitment, development, and retention of all QC staff, ensuring suitable training, qualification, and competency management to deliver a flexible and robust QC workforce.

· Lead the local design and execution of the global QC strategy and deployment, ensuring alignment with corporate objectives and compliance standards.

· Establish and maintain effective communication and networking with Quality professionals, both internally and externally, to ensure the ongoing application of evolving Quality Laboratory standards and regulatory requirements.

You will need to have:

· A minimum of 15 years’ experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality leadership

· BSc in Biochemistry, Chemistry, Microbiology or other life sciences. An advanced degree (MSc/PhD) is an advantage

· Extensive GMP laboratory/Quality management within a multi-national pharma/biopharma company is essential.

· Proven ability to build, mentor and grow agile high performing teams

· Knowledge of business and management principles involved in resource allocation, financial management, leadership and co-ordination of people and resources.

· Proven ability to work in a matrixed organization

· Extensive experience of the all regulatory requirements associated with QC methods, submissions & variations

We would prefer for you to have:

· Experience in a leadership role within a biopharmaceutical company.

· Skilled in organisation, planning and priority setting.

· Previous experience in handling regulatory audits and inspections.

· Experience working in a global and diverse work environment.

Date Posted

05-Aug-2026

Closing Date

18-Aug-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.