Director, Distribution and Affiliate Quality (Contractor) Marlow, England
Job description
Job Brief
Director, Distribution and Affiliate Quality - Contractor
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 Director, Distribution and Affiliate Quality, is responsible for the development, implementation, and continuous improvement of Amicus International’s Quality Management System. The role provides oversight of the company’s Distribution network and Affiliates, ensuring compliance with licenses, applicable regulations, and internal policies and procedures. The Director, Quality, will provide expertise and advice to the business, as well as support the development of a Quality Culture. The role will act as a Responsible Person (RP) and be named on applicable licenses.
Role and Responsibilities
The Director, Distribution and Affiliate Quality will:
- Act as a Responsible Person, named on Wholesale Dealers Authorization.
- Partner with the business to ensure Amicus International’s compliance with International and Local GMP and GDP Regulations and Guidelines.
- Facilitate or host inspections by regulatory authorities and maintain a state of inspection readiness.
- Provide Oversight of Amicus International’s Distribution network and Affiliates.
- Act as a GDP subject matter expert providing coaching, advice and training to the team and wider business.
- Support International and Global QA, Supply Chain, and Market and Product launch projects.
- Lead or participate in Management Reviews, Self-Inspections, audits and mock recalls.
- Author, review and approve GMP and GDP quality records such as deviations, change controls, CAPA, and Complaints within agreed lead-times.
- Lead and participate in continuous improvement project to ensure effective and compliant processes, systems and procedures.
Requirements
Educational Requirements
- A degree in Pharmacy, Chemistry or Biosciences
- Eligible to be a Responsible Person (RP) and Responsible Person for import (RPi)
Professional Work Experience
- Significant experience of in bio/pharmaceutical, GMP & GDP related Quality environment.
- Experience acting as Responsible Person and/or Qualified Person.
- Experience of External auditing and Regulatory Inspections
Experience and Skills
- 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.
Other skills/Attributes
- Demonstrated alignment with Amicus Mission Focus Behaviors
- Passion for rare disease and patient focused
Location
- Preferred location is Marlow, UK (with a hybrid work approach)
Travel
- Requires travel domestically and internationally up to 20%
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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