Associate Director, Quality Control

Alexion; Athlone; On-site; EUR 120,000 - 180,000; Full time

Job summary

Alexion in Athlone is seeking a senior Quality Control leader to oversee analytical and microbiological QC activities, ensuring GMP compliance, data integrity, and readiness for inspections. You will lead a cross-functional QC team and align with regulatory expectations across testing specifications and materials release.

The role requires 15+ years in pharma/biopharma quality leadership and a life sciences degree (BSc), with MSc/PhD as an advantage.

Qualifications

• 15+ years’ experience in quality leadership in pharma/biopharma.
• GMP laboratory/Quality management within a multinational pharma/biopharma company is essential.
• Proven ability to build, mentor and grow agile high performing teams.
• Experience with regulatory audits and inspections is preferred.

Responsibilities

• Provide leadership and oversight to QC laboratory functions, ensuring testing standards and GMP/EAEU compliance.
• Review/approve raw materials, intermediates, and finished products against specifications and quality standards.
• Ensure calibration, validation/qualification and maintenance of QC equipment and systems.
• Maintain data integrity and readiness for internal and regulatory audits.
• Lead the development and deployment of QC standards, procedures and GMP documentation.
• Represent QC in regulatory inspections and cross-functional quality forums.

Skills

Quality leadership

Leadership

Regulatory knowledge

Education

BSc in Life Sciences (Biochem, Chem, Microbiology)

MSc/PhD (advantage)

Job description

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.