Quality Manager (Contract)

Contract Quality Manager

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.

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 .

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