Quality Compliance Lead

Responsibilities

• Lead and improve the effectiveness of the site Quality Management System to deliver compliant, reliable, and inspection-ready outcomes.
• Govern site QMS processes, including CAPA, deviations, change control, risk management, documentation, training, and data integrity.
• Assess QMS performance through metrics, management review, and inspection feedback.
• Drive system-level improvements to address gaps and strengthen process integration.
• Lead and manage site inspection readiness and regulatory engagement, maintaining a continuous state of readiness.
• Act as the primary site Quality host for regulatory inspections and third-party audits.
• Coordinate inspection preparation activities, including mock inspections and risk-based reviews.
• Review and approve inspection responses, ensuring commitments are root-cause based and QMS-aligned.
• Maintain current knowledge of global and regional regulatory requirements and best practices.
• Provide Quality oversight and governance across technical functions & QC ensuring alignment with GMP requirements.
• Ensure equipment, utilities, and systems are qualified, controlled, and maintained in a validated state.
• Lead and manage cross-functional team participation as a Quality Assurance representative.
• Build strong partnerships across various functions to embed Quality perspectives in strategies and initiatives.

Requirements

• Required Skills:
• Bachelor's degree in science or directly related discipline.
• Significant years of experience in the pharmaceutical or biotechnology industry with strong expertise in within GMP Sterile manufacturing environments.
• Strong background and experience managing health authority inspections and communications in a pharmaceutical or biotechnology manufacturing site.
• Demonstrated experience leading Quality Compliance activities and inspection readiness.
• Working knowledge of the lifecycle of GMP equipment, facilities, and computerized systems.
• Proven people leadership experience in coaching, developing, and managing professional employees and contractors.
• Experience interpreting and applying global regulatory requirements and guidance to site-level quality systems and processes.
• Strong written and verbal communication skills.
• Preferred Skills:
• Advanced degree preferred.
• Eligibility for Qualified Person (QP) is a distinct advantage.
• Demonstrated ability to influence cross-functional stakeholders and operate effectively within a matrixed environment
• Job Level: Management
• Why Biogen?

Benefits

Additional Information

About This Role: As the Quality Compliance Lead, you will provide strategic, tactical, and operational leadership to ensure the Quality organization consistently meets site quality, manufacturing, and regulatory objectives, directly supporting business and site goals. You will lead a high-performing team and assure sustained compliance with cGMP requirements and the Quality Management System. Acting as a senior quality leader and trusted advisor, you will oversee governance and decision-making for both near-term operational execution and long-term site growth. Your role will be integral to batch release, quality systems effectiveness, validation and qualification oversight, and inspection readiness. You will be responsible for driving a continuous Quality and Compliance improvement mindset, reinforcing a strong quality culture across the site while fitting seamlessly into the broader organizational structure. This role requires working on site for 5 days per week in Athlone.

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