Lead and provide hands-on Quality leadership and support on the manufacturing floor.
Act as the primary Quality decision-maker, offering real-time guidance on GMP compliance and deviation management.
Govern the management of deviations, non-conformances, and exceptions, ensuring thorough and scientifically sound investigations.
Own batch release and product disposition, ensuring risk-based batch release decisions in line with specifications and regulatory standards.
Ensure the effective application of the Quality Management System, monitoring performance and driving improvements.
Support inspection readiness and regulatory engagement, acting as a key Quality contributor during inspections and audits.
Maintain up-to-date knowledge of regulatory requirements, applying this knowledge pragmatically at the site level.
Lead cross-functional partnerships to embed Quality expectations into batch planning and execution.
Promote a strong Quality culture through coaching and role modelling, reinforcing GMP ownership at all levels.
Requirements
Required Skills:
Bachelor's degree in science or a directly related discipline.
Significant years of experience in the pharmaceutical or biotechnology industry, with expertise in sterile manufacturing environments.
Proven leadership experience in coaching, developing, and managing professional teams.
Experience interpreting and applying global regulatory requirements (e.g. EU , FDA, ICH).
Demonstrated ability to influence cross-functional stakeholders and operate within a matrixed environment.
Strong written and verbal communication skills.
Preferred Skills:
Advanced degree.
Eligibility for Qualified Person (QP) status.
Job Level: Management
Why Biogen?
Additional Information
About This Role:
As the Senior Manager, Plant Quality Assurance, you will be at the forefront of ensuring the compliant execution, review, and release of manufacturing batches at our site. Supporting our manufacturing operations, you will provide end-to-end Quality oversight of batch-related activities, including real-time support on the manufacturing floor, review and approval of GMP documentation, and leadership in deviation, non-conformance, and exception investigations.
Your role will be pivotal in partnering with Manufacturing, Manufacturing Sciences, Validation, Engineering, and Quality Control to ensure that our processes meet regulatory requirements and product licensing commitments. You will ensure that issues are identified promptly, investigated thoroughly, and resolved effectively, all while maintaining a strong focus on patient safety, data integrity, and sustainable GMP compliance.
As a critical decision-maker for batch disposition, you will apply your Quality judgement to ensure batch acceptability and lead the implementation of corrective and preventive actions. Your visible leadership will promote a strong quality culture, reinforce GMP behaviours, and support continuous inspection readiness.
This role requires working on site for 5 days per week in Athlone.
Biogen · Athlone, Ireland