Senior Specialist, External QC

*Role can be based from Dublin, Athlone or Cork site*

This is what you will do:

• As the Senior QC Specialist you will play a pivotal role in leading the coordination, technical and quality oversight of routine testing at laboratories external to Alexion where Alexion products are tested. In addition, you will be responsible for leading method troubleshooting, Out of Trend/Specification investigations, APQRs, change controls and CAPAs performed at these laboratories. 

You will be responsible for:

• Lead the co-ordination and management of laboratories external to Alexion which support the testing of Alexion products through regular communications via weekly/monthly/quarterly meetings as deemed necessary. 
• Provide routine analytical and technical guidance to external laboratories where Alexion products are tested. 
• Lead the onboarding of External Laboratories, including writing of QAG. 
• Own and lead complex analytical investigations providing guidance to external laboratories. 
• Facilitate communications regarding deviations, change control and laboratories investigations between external laboratories and Alexion staff members. 
• Tracking of product testing at external laboratories and liaising with Quality and Supply Chain providing accurate updates on status of product testing. 
• Communicate and provide regular updates to higher level management as required, escalating risks in a timely manner. 
• Support operation of the external laboratories including review of APQRs, change controls, CAPAs, investigation review and process improvements.  
• Support analytical method transfer activities into Alexion and to external laboratories. 
• Provide technical leaderhip and conduct method troubleshooting as required. 
• Liaise with the Regulatory team to provide information related to analytical test procedure and analytical data from external tests laboratories as required. 

• Write and revise SOPs, review and approve transfer protocols and reports as assigned. 
• Ensure alignment of Alexion product analytical test procedures across external laboratories and Alexion laboratories. 
• Representative on change control review boards for all products to assess impact of all change controls and manage implementation activities as required. 
• Perform all job functions in compliance with cGMPs and maintain accurate and legible records. 
• Ensure training is current for all job functions and attend all required company training. 
• Audit external laboratories if required and support inspection readiness at external laboratories. 

You will need to have:

• Bachelor’s degree in a relevant scientific field;
• Minimum 5 years of experience in Quality Control
• In-depth understanding of relevant regulatory requirements (e.g., FDA, EMA) and industry standards for quality control in pharmaceuticals.
• Strong interpersonal and communication skills, with the ability to collaborate effectively with internal and external stakeholders.
• Exceptional analytical and problem-solving skills, with the ability to make data-driven decisions.
• Proven ability to lead and manage complex projects, ensuring timely and high-quality deliverables.
• Demonstrated commitment to maintaining a culture of quality and compliance.

We would prefer for you to have:

• Master’s or Ph.D. in a relevant scientific field.
• Experience working in a multinational environment or with global teams.
• Experience in regulatory inspections, and/or conducting or leading internal or external audits.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.