Supplier Assurance Management Lead

4 weeks ago

Windsor Berkshire, United Kingdom OTSUKA PHARMACEUTICAL EUROPE LTD. Full time

Oversee supplier related changes and implementation of required actions to address changes.

•Track supplier quality on a monthly/quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions.

•Communicate to management quality and regulatory issues on a timely basis.

•Maintain an Approved Supplier List and define areas to be targeted during the assessment or evaluation.

•Identify and leverage best practices across supplier qualification, surveillance, process and quality management system audits.

•Assist in the selection process for new suppliers

•Drive compliance excellence by assurance of compliance through robust Global Quality Management Systems, risk-based Global Audits, cross GxPs Inspection Readiness and strong partnership with the business functions to enable Otsuka product success.

•Contribute to the development of and maintenance of the quality system

•Prepare and maintain GMP documentation such as standard operating procedures and Quality Technical Agreements

•Act as approver of certain Quality Technical Agreements

•Liaise with suppliers for the management of returned/defective Product

•Work with suppliers for the development, agreement and documentation of processes

•Contribute to Global Quality goals, projects and initiatives

•Perform activities on behalf of the Responsible Person for Wholesale named on OPEL’s Wholesale Distribution Authorisation and deputise for the Responsible Person/Senior Director, Global Product Quality as appropriate

•Provide support and advice relating to the manufacturing and technical content of the Company’s product licences and submissions

•Ensure that the requirements and conditions of the Company’s product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures.

•Provide support to other functions within the OPEL Global Product Quality team, such as:

•Supporting the Quality Control Laboratory

•Batch record reviews

•Management, monitoring, review and approval of Change Controls, Deviations, CAPAs and PQCs

•Conducting training sessions on Quality processes

•Providing support to regulatory inspections

•Artwork approvals

•OPEL’s Serialisation solution in relation to the Falsified Medicines Directive

Leadership & Behavioural Competencies for this position are:

Minimum Qualifications:

•Bachelor Degree level plus, further qualification in auditing desirable

•Several years’ experience working in a Pharma Quality Role.

•Excellent written and spoken English.

•Industry experience of manufacturing, automated packaging and distribution sites (GMP and GDP)

Preferred Qualifications:

•First rate communication skills

•Proven experience of successfully working in a multi cultural environment

•Well organised, with strong planning skills and an ability to grasp complex and multifactorial data quickly.

•Resilience and confidence, clear thinking and ability to deliver to tight timescales.

•Personable and empathetic, with the ability to understand conflicting viewpoints and ability to influence leading to problem resolution.

•Pro Active approach with a sense of urgency.

Functional & Technical Competencies for this position are:

•High attention to detail

•Very good written and spoken English

•Excellent time Management & organisational skills

•Ability to pro-actively identify issues and seek resolution

•Experience in management of GMP/GDP Quality Management Systems

•Additional relevant QA experience

•Excellent written and verbal communication skills

•Ability to learn quickly and adapt quickly to changing requirements

•Ability to work to tight deadlines

•Good problem solving skills

•Must be able to handle sensitivity and confidentiality levels appropriately.

•Ability to negotiate with third parties on Quality processes

•Based at the OPEL office, with significant travel, mainly in Europe, but also in Asia and North America.

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