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 Quality Assurance Manager will:
· Work to ensure the compliance of Amicus International with Local and International GMP and GDP regulations, guidelines, local and global procedures, and policies and may also act as Responsible Person (RP).
· Work in partnership with Global Quality team, the QA Manager will develop, implement, and ensure the continuous improvement of Amicus International’s Quality Management System.
· Provide oversight of the company’s Distribution activities, ensuring compliance with all licenses, applicable regulations, and internal policies and procedures.
· Working in partnership with Supply Chain and internal business functions to ensure a reliable and compliant supply of products to our patients.
· Support projects, product, and market launches.
Roles and Responsibilities:
Responsibilities include:
· Partner with the appropriate Amicus business functions to ensure Amicus International and the wider businesses’ compliance with International and Local GMDP Regulations and Guidelines.
· Participate in inspections by regulatory authorities and maintain a state of effective readiness to ensure successful inspection outcomes.
· Participate in Management Reviews, Self-Inspections, audits, and mock recalls.
· Produce and act on reports and metrics to support the effective and compliance operation of the team.
· Support International and Global QA, Supply Chain, and Market and Product launch projects.
· Author, review and approve GMP and GDP quality records such as deviations, change controls, CAPA, and Complaints.
· Support Vendor Oversight including routine and qualification audits of external partners.
· Lead and participate in continuous improvement project to ensure effective and compliant processes, systems and procedures.
· Act as a GMP and GDP subject matter expert providing coaching, advice, and training.
· May act as a Responsible Person, being named on Wholesale Dealers Authorisation .
Requirements
Educational Requirements
· A degree (or equivalent) in Pharmacy, Chemistry or Biosciences.
· Proven experience working within a bio/pharmaceutical, GMP & GDP related Quality environment.
Professional Work Experience Requirements
· A passion for helping patients with rare diseases
· A strong moral compass and clear alignment with Amicus Mission Focused Behaviors
· Experience of external auditing and Regulatory Inspections
· Strong decision making and analytical problem solving.
· Flexible, highly motivated, with strong organization skills and the ability to multitask.
· Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic international environment.
· Ability to work independently and to make appropriate decisions based on experience.
· Strong interpersonal, communication and influencing skills with experience of engaging and working successfully with key stakeholders across cultures.
· Ability to lead projects and deliver objectives within a matrix organization.
· Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Other skills/Attributes
· Demonstrated alignment with Amicus Mission Focus Behaviors
· Passion for rare disease and patient focused
Travel
· This position will be based at Marlow, United Kingdom
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.