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Associate Director, Quality Technical
Amicus TherapeuticsIrelandfull_timeVerifiedPosted 6 Nov 2025
About the role
Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.
Position Summary
The Associate Director, Quality Technical is responsible for leading Amicus’ Quality Technical activities, ensuring robust delivery of projects and compliance of our Internal and External GMP Operations. The role is accountable for the development, implementation, and continuous improvement of GMP Quality projects, ensuring the Quality and compliance of our GMP activities, including product development, process development and testing. The position requires leadership, exceptional technical expertise, and a deep understanding of project management. Roles and Responsibilities:
• Lead the Quality Technical activities, ensuring appropriate resources and prioritization to support the compliant execution of the activities.• Partner with the business to ensure Amicus’ compliance with Global GMP Regulations and Guidelines.• Ensure appropriate Quality Leadership of Technical projects in Manufacturing and Quality Control activities within Amicus and External Partners.• Ensure adequate training and qualifications of staff involved in GMP activities.• Communicate and, as appropriate, escalate significant quality systems or product issues and make recommendations for process improvements and the promotion of best practices.• Provide Quality leadership of GMP Technical activities, including product development, manufacturing process development, and testing, ensuring compliance with regulatory requirements and company standards.• Work closely with Regulatory Affairs and Technical Operations teams to ensure alignment and compliance of internal and external GMP activities with regulatory requirements and industry standards.• Oversee external manufacturing activities, including technical and analytical transfer, to ensure the quality and compliance of products manufactured by external partners.• Develop and maintain strong relationships with external partners to drive quality and operational excellence on Technical projects. •Develop and maintain an effective GMP Quality System for use in Product and analytical Development and Qualification , including the establishment of policies, procedures, and processes to ensure compliance with regulatory requirements and industry standards.• Identify opportunities for process improvements and quality enhancements across GMP activities. Implement best practices and quality initiatives to drive continuous improvement in quality systems and processes.• Collaborate with cross-functional teams, including Manufacturing, Supply Chain, CMC and Clinical Operations, to support the successful development and commercialization of products.
Requirements Educational Requirements· A degree in Pharmacy, Chemistry or Life Sciences. Professional Work Experience Requirements · A passion for helping patients with rare diseases· A strong moral compass and clear alignment with Amicus Core Values· Experience in GMP Quality Leadership roles in biotechnology or pharmaceutical industry.· Experience in External Manufacturing and working with external partners.· Experience of Product Development, technical and analytical transfer.· Knowledge of global GMP regulations and guidelines, including EU, US, UK, Japan, and other global jurisdictions.· Strong leadership and communication skills, with the ability to collaborate effectively across functions and with external partners.· Excellent judgment and decision-making, demonstrating ability to analyse and solve problems.· Experience of leading cross-cultural Quality teams.· Autonomy, self-motivation and efficiency, with an appropriate sense of urgency in a fast-paced and dynamic environment.· Experience of managing complex projects, leading cross-cultural teams and budget planning.· Knowledge of Pharmaceutical Drug Substance and Drug Product Manufacturing operations.· Strong verbal and written skills with ability to explain complex, challenging iss
Position Summary
The Associate Director, Quality Technical is responsible for leading Amicus’ Quality Technical activities, ensuring robust delivery of projects and compliance of our Internal and External GMP Operations. The role is accountable for the development, implementation, and continuous improvement of GMP Quality projects, ensuring the Quality and compliance of our GMP activities, including product development, process development and testing. The position requires leadership, exceptional technical expertise, and a deep understanding of project management. Roles and Responsibilities:
• Lead the Quality Technical activities, ensuring appropriate resources and prioritization to support the compliant execution of the activities.• Partner with the business to ensure Amicus’ compliance with Global GMP Regulations and Guidelines.• Ensure appropriate Quality Leadership of Technical projects in Manufacturing and Quality Control activities within Amicus and External Partners.• Ensure adequate training and qualifications of staff involved in GMP activities.• Communicate and, as appropriate, escalate significant quality systems or product issues and make recommendations for process improvements and the promotion of best practices.• Provide Quality leadership of GMP Technical activities, including product development, manufacturing process development, and testing, ensuring compliance with regulatory requirements and company standards.• Work closely with Regulatory Affairs and Technical Operations teams to ensure alignment and compliance of internal and external GMP activities with regulatory requirements and industry standards.• Oversee external manufacturing activities, including technical and analytical transfer, to ensure the quality and compliance of products manufactured by external partners.• Develop and maintain strong relationships with external partners to drive quality and operational excellence on Technical projects. •Develop and maintain an effective GMP Quality System for use in Product and analytical Development and Qualification , including the establishment of policies, procedures, and processes to ensure compliance with regulatory requirements and industry standards.• Identify opportunities for process improvements and quality enhancements across GMP activities. Implement best practices and quality initiatives to drive continuous improvement in quality systems and processes.• Collaborate with cross-functional teams, including Manufacturing, Supply Chain, CMC and Clinical Operations, to support the successful development and commercialization of products.
Requirements Educational Requirements· A degree in Pharmacy, Chemistry or Life Sciences. Professional Work Experience Requirements · A passion for helping patients with rare diseases· A strong moral compass and clear alignment with Amicus Core Values· Experience in GMP Quality Leadership roles in biotechnology or pharmaceutical industry.· Experience in External Manufacturing and working with external partners.· Experience of Product Development, technical and analytical transfer.· Knowledge of global GMP regulations and guidelines, including EU, US, UK, Japan, and other global jurisdictions.· Strong leadership and communication skills, with the ability to collaborate effectively across functions and with external partners.· Excellent judgment and decision-making, demonstrating ability to analyse and solve problems.· Experience of leading cross-cultural Quality teams.· Autonomy, self-motivation and efficiency, with an appropriate sense of urgency in a fast-paced and dynamic environment.· Experience of managing complex projects, leading cross-cultural teams and budget planning.· Knowledge of Pharmaceutical Drug Substance and Drug Product Manufacturing operations.· Strong verbal and written skills with ability to explain complex, challenging iss
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