Executive Director, Head of Quality - Research, Development, and Pharmacovigilance Quality

Amicus Therapeutics•Princeton, NJ

55d•$284,000 - $300,000•Hybrid

About The Position

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 Executive Director, Research, Development & Pharmacovigilance Quality will lead the strategic and operational oversight of quality systems across GLP, GCP, and GVP Quality Systems. This role will partner cross-functionally with Science, Clinical Research, Clinical Operations, and Global Drug Safety to ensure regulatory compliance, inspection readiness, and continuous improvement. The role will also be responsible for leading regulatory inspections, implementing continuous improvement initiatives, managing the GLP/GCP audit program, budget management, resource planning, strategic planning, KPIâs Management Reporting, Risk Management, Quality Governance and development of our Quality Culture.

Requirements

Advanced degree in Pharmacy, Chemistry, Biosciences, or related field.
Significant experience in biotech/pharmaceutical industry and Quality Leadership in a global environment.
Demonstrated experience in leading and developing teams, with a proven ability to foster a high-performance culture, drive engagement, and support individual growth through coaching and feedback.
Strong knowledge and understanding of FDA, EMA, and other International GLP/GCP/GVP regulations, guidelines, and quality standards.
Proven experience in developing, implementing, and maintaining GLP/GCP/GVP quality systems, KPI tracking, management reporting, risk management, quality governance, people management, and leadership.
Experience of External auditing and Regulatory Inspections
Strong decision making and analytical problem solving.
Ability to manage conflict and influence effectively at all levels.
Flexible, highly motivated, with strong organizational skills and the ability to multitask.
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
Ability to work independently and to make decisions based on experience.
Strong interpersonal, communication and influencing skills. Experience working across cultures.

Responsibilities

Develop and maintain robust quality systems for GLP, GCP, and GVP in alignment with global regulatory requirements.
Provide strategic leadership for quality oversight across clinical trials, nonclinical studies, and pharmacovigilance activities.
Partner with Global Drug Safety to ensure effective implementation of the GVP quality system, including signal detection, risk management, and safety reporting.
Lead inspection readiness and manage regulatory inspections across GLP, GGP, and GVP Quality Systems.
Oversee internal and external audits, ensuring timely resolution of findings and implementation of corrective actions.
Collaborate with Science and Clinical teams to embed quality into study design, execution, and reporting.
Establish and monitor KPIs to assess quality performance and drive continuous improvement.
Manage departmental budget, resources, and staffing to support global quality operations.
Serve as a senior advisor to leadership on quality risks, mitigation strategies, and compliance trends.