Quality Compliance Lead - External Biologics

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Job Description

About the Role

As the Quality Compliance Lead for External Biologics, you will be responsible for maintaining and implementing procedures and practices aligned with global Health Authority expectations for Takeda’s External Biologic Operations. You will lead and coordinate inspection-related activities at Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs), ensuring continuous inspection readiness and compliance. Acting as the key link between Global Quality Compliance and External Biologics, you will play a critical role in safeguarding product quality and patient safety across External Biologics supply at Takeda.

How You Will Contribute

• Lead External Biologics Regulatory Inspections at Takeda Ireland (HPRA & Russian MIT).
• Lead Takeda CMOs and CTLs in inspection readiness, inspection support, and inspection remediation actions as required.
• Lead and maintain up-to-date Takeda Baggot Street Site Master File (SMF).
• Lead the External Biologics Internal Audits and Self-Inspection program.
• Lead Compliance Risk Assessments for External Biologics.
• Lead and maintain the Product Quality Review process for External Biologic Products.
• Maintain knowledge of current applicable global regulatory requirements.
• Apply knowledge of cGMPs on a daily basis to ensure operational compliance.
• Manage day-to-day operations independently, providing strategic oversight and problem resolution.
• Present viable alternatives within problem resolution and assist in ensuring effective risk mitigation.
• Routinely partner with senior management on critical compliance issues.

• Participate in and lead Continuous Improvement projects to enhance compliance and quality systems.

• Support MAH activities for Takeda Pharmaceutical International - Ireland |Branch.

What You Bring to Takeda

• Bachelor’s or advanced degree in a relevant scientific or technical discipline.
• Minimum of 8 years’ experience in Quality Systems and Compliance within biologics or sterile manufacturing environments.
• Proven leadership experience managing quality or technical teams in a global biopharmaceutical setting.
• Strong understanding of cGMP/GLP regulations, ICH guidelines, FDA CMC expectations, and related international standards.
• Demonstrated knowledge of biologics and aseptic manufacturing processes, systems, and technologies.
• Experience interacting with regulatory agencies and leading site or external partner inspections.
• Ability to influence, collaborate, and communicate effectively across internal and external stakeholders.
• Strong analytical, risk assessment, and decision-making skills in complex, regulated environments.
• Commitment to Takeda’s values—Patient, Trust, Reputation, and Business—driving quality excellence across all activities.

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