European Quality Manager

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We are excited to announce that we are hiring a European Quality Manager to support our European Quality team, primarily focusing on Alvita and Almus. This is a fantastic opportunity for a dedicated professional to make a significant impact on our quality assurance processes and ensure compliance with regulatory standards.

• Probation Period: Fully onsite.
• Post-Probation: Hybrid working model, with 3 days in the office and 2 days remote.

• To be part of the Quality Team, responsible for supporting the private label brands of Alliance Healthcare (Almus and Alvita) which are managed by a multifunctional Central Team located in the divisional head office, in Woking, UK.
• Responsible for the development and management of the Alvita Quality Management System (QMS) across all Alliance Healthcare Businesses which market Alvita products.
• The QMS encompasses the development and adherence to processes and procedures necessary for ensuring Alvita branded products are managed effectively throughout the entire lifecycle.
• To ensure the Alvita QMS supports the necessary governance to be applied in the introduction and maintenance of existing products in the market, to ensure legal compliance is maintained, protecting consumers and the reputation of the brand.
• To support the extension of the Alvita product range across the UK and continental Europe and into new potential new markets in accordance with agreed 5-year growth plan.
• To support the continued development of the Almus and Alvita businesses by managing key technical and quality related activities necessary to introduce new and maintain existing Almus and Alvita branded products on the market in a legally compliant manner throughout their entire lifecycle.
• Provide the technical and quality leadership to the Alliance Healthcare business on resolving quality issues, handling and management of quality complaints and fulfilling vigilance obligations with suppliers.

• Lead the development and maintenance of the Alvita QMS. Support the on-going development of both QMS centrally and across all EU affiliates, ensuring compliant use of all systems.
• Responsible for the development of appropriate central and local procedures and working practices, in collaboration with central and local teams, to ensure Alvita complies with all European and national regulations and internal policies. Provide training as author or subject matter expert.
• Work with the Central Quality Team and sourcing colleagues, to ensure all relevant technical agreements are in place with manufacturers for Alvita products prior to supply commencement and reviewed periodically.
• Support the NPD process for Alvita markets and Almus affiliates. Participate in cross functional project meetings to deliver NPD projects to plan and share expertise across the business.
• Responsible for managing the qualification of Alvita suppliers in accordance with NPD project timelines, supporting the extension of the Alvita range in accordance with the growth plan.
• Support the delivery of the ethical audit schedule with third party providers, supplying Alvita, in accordance with an agreed audit schedule. Manage the follow-up of audits, implementation of CAPA’s and appropriate closure to ensure effective resolution of audit findings in a timely manner.
• Support and manage the handling of product quality complaints, quality incidents, deviations and corrective and preventative actions (CAPAs). Coach the affiliates in root cause analysis, CAPA generation and management ensuring appropriate actions are identified and all investigations are completed to the defined timeframes.
• Conduct Risk Assessments following a Quality Incident or identified non-conformance, affecting any own brand product, that could require in-market action, such as a product recall.
• Working with the Central Quality Team generate and/or review GMP Product Quality Reviews for all Almus products in market in accordance with the defined schedule.
• Manage the preparation of Product Quality Reviews for all Almus products in accordance with a defined schedule.
• Contribute as the “quality lead” as applicable, to specific Almus and Alvita projects impacting on the business as they arise due to legislative changes or internal requirements.

• Degree in Chemistry, Pharmacy or a relevant Life Science.

• Strong understanding of Quality Management Systems (QMS) principles and methodologies.
• Knowledge of relevant regulatory standards (e.g., EU GMP) depending on industry.
• Excellent communication and interpersonal skills to collaborate with diverse teams.
• Self-motivated dynamic individual, with the ability and desire to work proactively, with limited supervision.
• Excellent analytical, problem-solving skills and IT skills.
• Ability to prioritise and organize workload and to have a proven track record of working effectively under pressure.
• Proven ability to communicate clearly and logically, both orally and in written form.
• Appreciation of the commercial goals of the organisation and the desire to contribute to the successful fulfilment of these goals.

• Experience working in Quality and/or Production within the Medical Device and/or Pharmaceutical Industry.
• Proven experience in implementing quality system in the Medical Device or Pharmaceutical Industry.
• Knowledge of appropriate European regulations and guidelines within the Medical Devices and/or Pharmaceutical Industry.