GMP Quality & Technical Projects Leader

Amicus Therapeutics, Inc.; Dublin; Hybrid; EUR 150,000 - 190,000; Full time

Job summary

Amicus Therapeutics, Inc. is seeking an Associate Director, Quality Technical to lead GMP Quality activities and ensure compliant execution across internal and external GMP operations.

The role focuses on developing and improving GMP Quality projects, with leadership in product and process development and testing, working with Regulatory Affairs and Technical Operations. The ideal candidate will have deep GMP knowledge, strong leadership and cross-functional collaboration skills, and a track

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry or Life Sciences.
• Experience leading GMP quality programs in biotech/pharma.
• Strong leadership, cross-functional collaboration, and global regulatory knowledge.
• Experience with external manufacturing and tech transfers.

Responsibilities

• Lead GMP Quality Technical activities with resources and prioritization to support compliant execution.
• Partner with the business to ensure compliance with Global GMP Regulations and Guidelines.
• Provide Quality leadership of Technical projects in Manufacturing and Quality Control.
• Oversee external manufacturing activities, including transfer activities, to ensure quality and compliance.
• Develop and maintain an effective GMP Quality System for development and qualification, including policies and processes.
• Collaborate with Manufacturing, Supply Chain, CMC and Clinical Operations to support development and commercialization.

Skills

GMP Quality Leadership

External Manufacturing

Regulatory knowledge

Cross-functional collaboration

Project management

Education

Pharmacy, Chemistry or Life Sciences degree

Job description

Amicus Therapeutics, Inc. is seeking an Associate Director, Quality Technical to lead GMP Quality activities and ensure compliant execution across internal and external GMP operations.

The role focuses on developing and improving GMP Quality projects, with leadership in product and process development and testing, working with Regulatory Affairs and Technical Operations. The ideal candidate will have deep GMP knowledge, strong leadership and cross-functional collaboration skills, and a track