European Quality Manager

Job title:

European Quality Manager

Company

Lifelancer

Job description

Job Title: European Quality ManagerJob Location: Woking, UKJob Location Type: HybridJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!Job Details#INDWCJoin Our European Quality Team!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.Position Details

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

The Role

• 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. This includes processes and procedures related to but not limited to: Quality, Regulatory, vigilance, new product development and supplier management etc.
• 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.

JOB CONTEXTAlvita is Alliance Healthcare’s own brand of patient care products, with over 850 products covering medical devices, cosmetics and biocides, currently sold in in 7 markets across Europe, with plans for further expansion in 2 markets in 2025.The Alvita brand has been identified as a key company growth initiative, with a 5-year plan targeting 2.5 x growth of current revenue and doubling of profit. Over half of the targeted growth will come from New Product Development (NPD) launches, this role will be integral in the delivery of the NPD required to support the growth plan.Almus is the generic brand of medicines owned by the Alliance Healthcare. Almus is marketed in 5 European markets and has approx. 450 products within the range. The legal status of Almus in each market varies, in some markets Almus is a marketing authorisation holder, Exploitant or own label distributor.The Almus and Alvita ranges are supplied by over 85 suppliers located in 35 different countries.The Almus and Alvita businesses are supported by a Central Quality Team. There is no in-market quality expertise. The Central Quality Team, under the management of the Technical and Sourcing Director, provides a service to all Almus and Alvita business units.The Central Quality Team must be fully integrated with other key functions; Commercial, Sourcing and Supply Chain, Regulatory, Pharmacovigilance and the local in market teams to ensure business continuity.This role requires an individual who can develop strong working relationships, work in partnership across all European business units to support key regulatory and quality tasks required to ensure Products and Regulatory data are managed throughout the product lifecycle, in accordance with the requirements of the Alvita and Almus Quality Management and Vigilance Systems.Key Responsibilities

• 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.

JOB HOLDERS SPECIFICATION

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

Specific Skills

• 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

• 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.

What Cencora offersBenefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.Full timeAffiliated CompaniesAffiliated Companies: Alliance Healthcare Management Services LimitedEqual Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returnedLifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

Expected salary

Location

Woking, Surrey

Job date

Sat, 22 Feb 2025 23:52:53 GMT

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