AddressJob Brief
Senior Director, Head of Global Quality Systems
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 Senior Director, Head of Global Quality Systems, will be responsible for leading the Global Quality Systems team with responsibility for the Quality Management Systems (QMS), Computer System Validation (CSV), and Continuous Improvement efforts. This position is key in supporting our mission, and the development, manufacturing and supply of our products to our customers and patients. The role will work to collaborate with key stakeholders to provide services for day to day GXP operations related to Quality Events, Investigations, CAPA, Change Management, Training, Document Management & Archival, Supplier Quality and Internal & External Audit Programs across the organization. Additionally the role will lead our continuous improvement activities across the Glonbal Quality Organisation. Lead Quality strategic initiatives to support the business goals and objectives. This includes leading/supporting long term Quality Strategy for Amicus and implementation activities. The Senior Director, Global Quality Systems will work collaboratively with all parts of the business to ensure compliance with Global Quality and regulatory requirements and drive a culture of quality throughout the company.
Role and Responsibilities
- Quality Management Systems (QMS) Oversight:
- Develop, implement, and maintain an effective, value adding QMS that meets international regulatory requirements.
- Ensure the effectiveness of our Quality System through regular reviews, audits, and updates.
- Lead QMS-related change management initiatives and projects.
- Computer System Quality Assurance:
- Oversee the quality of all computer systems used in GxP environments, ensuring compliance with relevant standards and regulations.
- Implement and maintain data integrity and cybersecurity measures.
- Continuous Improvement:
- Foster a culture of continuous improvement within Global Quality.
- Implement tools and methodologies to drive process efficiencies and quality improvements.
- Inspection Readiness:
- Lead preparation activities for regulatory inspections and audits.
- Serve as a key contact for regulatory agencies, managing interactions and responses.
- Global GxP Compliance:
- Ensure compliance of Global GxP Quality Systems with FDA, EMA, and other relevant regulatory bodies.
- Stay up to date with regulatory changes and maintain compliance of our QMS with the evolving Regulatory environment.
- Cross-Functional Collaboration:
- Work closely with departments across the business, including R&D, Regulatory, Manufacturing, Supply chain, to integrate quality standards.
- Provide strategic quality input in company-wide decision-making processes.
- Global Business Support:
- Support the global expansion of the business by ensuring Quality Systems align with international standards and practices.
- Develop and maintain relationships with quality leaders in global markets.
Educational Requirements
- A degree in Pharmacy, Chemistry or Biosciences
Professional Work Experience
- Significant experience in biotech/pharmaceutical industry and Quality Leadership in a global environment.
- 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 organization skills and the ability to multi task.
- 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.
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 can be based in Marlow, UK or Princeton, NJ with a hybrid working arrangement.
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.
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