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

Amicus Therapeutics, Inc.; Princeton (NJ); Hybrid; USD 284,000 - 300,000; Full time

Benefits offered by this job

Health insurance

Retirement plan (401K)

Performance-based bonuses

Stock options

Paid time off

Job summary

A global biotechnology company in Princeton, NJ is seeking an Executive Director, Research, Development & Pharmacovigilance Quality. This strategic role involves overseeing quality systems and ensuring regulatory compliance. The ideal candidate has extensive biotech experience, an advanced degree, and strong leadership skills. The position offers a hybrid work arrangement and a competitive salary range of $284,000 to $300,000 with additional benefits.

Qualifications

• Significant experience in biotech/pharmaceutical industry and Quality Leadership in a global environment.
• Strong knowledge and understanding of FDA, EMA, and GLP/GCP/GVP regulations.
• Experience of external auditing and Regulatory Inspections.

Responsibilities

• Develop and maintain robust quality systems for GLP, GCP, and GVP.
• Provide strategic leadership for quality oversight across clinical trials and pharmacovigilance.
• Lead inspection readiness and manage regulatory inspections.

Skills

Leadership

Regulatory Compliance

Quality Management

Analytical Problem Solving

Interpersonal Communication

Education

Advanced degree in Pharmacy, Chemistry, Biosciences, or related field

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 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, KPI’s Management Reporting, Risk Management, Quality Governance and development of our Quality Culture.

Role and 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.

Educational Requirements

• Advanced degree in Pharmacy, Chemistry, Biosciences, or related field.

Professional Work Experience

• 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 ofExternalauditing and Regulatory Inspections
• Strongdecision making andanalytical problem solving.
• Ability to manage conflict and influence effectivelyat all levels.
• Flexible, highly motivated, with strongorganizationalskills and the ability tomultitask.
• 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.

Travel

• Requirestravel domestically and internationally up to20%.

Location

• This position can be based in Princeton, NJ with a hybrid working arrangement—3 days onsite.

Compensation and Benefit Summary

• The U.S. base salary range for this full‑time position is between $284,000 and $300,000 year. Within the range, individual pay is determined by work location and additional factors, including job‑related skills, experience, and relevant education or training. In addition to the base salary, employees may be eligible for various benefits, including health insurance, retirement plan (401K), paid time off, performance‑based bonuses, stock options, restricted stock units, and other discretionary awards. Details of participation in these benefit plans will be provided during the hiring process.

We value an inclusive environment where individual experiences and perspectives are celebrated, and voices from the rare disease community are heard.

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.