Executive Director, Head of Quality Operations

Job Brief

Executive Director, Head of Quality Operations 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. SUMMARY OF POSITION The Head of Quality Operations is responsible for leading Amicus’ Quality Operations Team, ensuring a robust GMP Quality System and compliance of our Internal and External GMP Operations. The role is accountable for the development, implementation, and continuous improvement of the Global GMP Quality System, and ensuring the Quality and compliance of our GMP activities, including product development, process development, and oversight of outsourced manufacturing, testing, and release. The position requires strong leadership, technical expertise, and a deep understanding of global GMP regulations and guidelines. ROLES AND RESPONSIBILITIES

• Lead the Global Quality Operations team, ensuring appropriate resources to support the compliant execution of the team's activities.
• Partner with the business to ensure Amicus’ compliance with Global GMP Regulations and Guidelines.
• Ensure appropriate Quality oversight of Manufacturing and Quality Control activities within Amicus and External Partners.
• Facilitate or host GMP inspections by regulatory authorities and maintain a state of inspection readiness.
• Ensure adequate training and qualifications of staff involved in GMP activities.
• Communicate and, as appropriate, escalate significant quality systems or product issues to leadership and make recommendations for process improvements and the promotion of best practices.
• Participate in Governance Processes, including Global Risk Committees, Quality Council and Quality Lead Team.
• Provide oversight of GMP activities, including product development, manufacturing process development, and outsourced manufacturing, testing, and release, 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.
• Prepare for and manage regulatory inspections conducted by authorities such as the FDA, EMA, PMDA, and other global regulatory agencies. Ensure readiness for inspections of both internal and external GMP operations.
• Lead the development and maintenance of an effective GMP Quality System, including the establishment of policies, procedures, and processes to ensure compliance with regulatory requirements and industry standards.
• Lead GMP quality governance activities, including management review meetings, to ensure effective oversight and continuous improvement of quality systems. Define appropriate key performance indicators (KPIs) and metrics to monitor compliance and performance against quality objectives.
• 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.

ORGANIZATIONAL STRUCTURE

• Reports to Vice President, Global Head of Quality

QUALIFICATIONS AND BACKGROUND REQUIREMENTS Educational Requirements

• A degree in Pharmacy, Chemistry or Life Sciences.
• Eligibility to act as a Qualified Person (QP).

Professional Work Experience

• 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.
• Depth 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.

Compensation

• A competitive compensation package will be presented to the right individual including base salary, bonus and equity.

Travel

• Requires travel domestically and internationally up to 20%.

Location

• This position will be based in either Marlow, Buckinghamshire, UK or Dublin, Ireland with a hybrid working arrangement.

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