Quality Manager (Alvita and Almus)

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 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.

2 JOB CONTEXT

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.

Alvita is Alliance Healthcare's own brand of patient care products, with over 650 products covering medical devices, cosmetics and biocides, currently sold in in 7 markets across Europe., with plans for further potential expansion.

The Almus and Alvita ranges are supplied by over 85 suppliers located in 35 different countries.

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.

The Almus and Alvita businesses are supported by a central quality team. There is no in-market quality expertise. The quality team, under the management of the Technical and Sourcing Director, centrally 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 Almus and Alvita Quality Management and Vigilance Systems.

3 ORGANISATION CHART

See departmental organogram

4 KEY RESPONSIBILITIES (what are the important functions for which the job holder is responsible? List a maximum of 8 and, where possible, do so in descending order of importance)

4.1 Lead the development and maintenance of the Alvita Quality Management Systems. Support the on-going development of both QMS centrally and across all EU affiliates, ensuring compliant use of all systems.

4.2 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.

4.3 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.

4.4 Responsible for managing the qualification of Alvita suppliers in accordance with NPD project timelines, supporting the extension of the Alvita range.

4.5 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.

4.6 Support the Almus affiliates with investigations following quality deviations, incidents and/or GMP/GDP audits. 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.

4.7 Support the NPD process for Almus affiliates and the Alvita teams. Participate in cross functional project meetings to deliver NPD projects to plan and share expertise across the business. Support the approval process of all suppliers and/or manufacturers.

4.8 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.

4.9 Supporting the revalidation requirements of Almus IT systems (Verify Brand Platform for FMD and Samarind for Regulatory management System), including conducting an assessment of the impact of new versions, determining the validation requirements, performing the process qualification tasks and preparing all necessary documentation. Work with the wider team to ensure the system retains its' validation status at all times.

4.10 Support the follow-up of GMP/GDP/Ethical and internal audits, implementation of CAPA's and appropriate closure to ensure effective resolution of audit findings.

4.11 Support the ethical audit schedule with third party providers 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.

4.12 Provide dedicated support to the French Almus and Alvita businesses providing quality expertise, resolution of quality issues and development of good practices thereby ensuring ongoing compliance with the requirements of the quality management system.

4.13 Manage the handling of product quality complaints for Alvita, ensuring where necessary risk assessments are prepared, issues resolved in a timely manner and communicated to the local team.

4.14 Support the on-going development of the Almus and Alvita QMS across all EU affiliates, ensuring compliant use of all systems. As appropriate, develop in collaboration with the European business units, appropriate central and local SOP's and working practices. Provide training as author and or subject matter expert.

4.15 Manage the preparation of Product Quality Reviews for all Almus products in accordance with a defined schedule.

4.16 Lead or 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.

4.17 Contribute as a key member of the team to the successful implementation of Identification of Medicinal Products (IDMP) standards into the IT tools and business processes in accordance with legislative deadlines.

5 EXPERIENCE

• Demonstrable business experience in a commercial role.
• Experience of working with FMCG and in particular with medical devices desirable.
• Experience of working with overseas teams desirable.
• Far East/Low Cost Country sourcing experience.

6 TRAVEL

Some European travel required.

What your background should look like

What Cencora offers

All team members globally are provided with basic life insurance, personal accident insurance, business travel accident insurance, and EAP resources at no cost. Additional country-specific benefits such as healthcare, sick leave, death and disability, retirement, as well as perks and allowances may be provided. Details of programs vary by location.

Schedule

Full time

Affiliated Companies

Affiliated Companies: Alliance Healthcare Management Services Limited

Equal Employment Opportunity

Cencora 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 hrsc@amerisourcebergen.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned