Associate Director, Quality Assurance Projects

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 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, elevate 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 issues in a clear manner to all levels of the organization, especially senior management.
• Strong interpersonal skills, including diplomacy and flexibility, and the ability to engage and influence effectively with key stakeholders across multiple geographies.

Other skills/Attributes

• Demonstrated alignment with Amicus Mission Focus Behaviors
• Passion for rare disease and patient focused

Travel

• Requires travel domestically and internationally up to 20%.
• Hybrid working - 3 days in office (Tues, Wed, Thur)

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.