External Supply Quality Manager

Job Description

Senior Supplier Quality Audit ManagerHello. We’re Haleon. A world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for millions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science.What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.We are inviting applicants for a new role: Senior Supplier Quality Audit Manager on a full-time permanent basis.The job exists within the Haleon Quality organization, to ensure Haleon Third Party Contractors (TPCs), Logistic Service Providers (LSPs) and other vendors meet GxP regulation and Haleon’s expectations.Why HaleonAt Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. Were strivingto create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agileworking culture for all our roles.If flexibility is important to you, we encourage you to explore the following opportunity.Are you looking for a GxP auditor role that allows you the opportunity to positively impact the live of millions of consumers by ensuring Haleon Third Party Contractors (TPCs), Logistic Service Providers (LSPs) and other vendors meet GxP regulation and Haleon’sexpectationsIf so, this Senior Supplier Quality Audit Manager role could be an ideal position to explore.Role and Responsibilities

• The primary purpose of this role is to perform and manage GMP and GDP compliance audits and assessments of Haleon Third Party Contractors (TPCs), Logistic Service Providers (LSPs) and other vendors located in Europe.
• The Individual may be expected to support/conduct for cause audits, special investigations, and support regulatory inspection preparation and conduct for Haleon manufacturing and R&D sites on an as needed basis.
• Preparation of a compliant audit strategy in Europe that reflects the minimum regulatory requirements, risk-based approach and commensurate with industry standard.
• Prepare an annual audit plan with appropriate compliance requirement and risk model elements in collaboration with the Business Units (BUs), Haleon Trading Service & Logistics, Contract Manufacturing Organization (CMO) and R&D Quality Heads.
• Manage requests for the assessment of new TPCs and LSPs and schedule audit activities to support the Haleon External Supply & Logistic Network
• Review and approve audit reports from peer auditors, as required by Haleon internal procedures.
• Provide training and coaching to SMEs performing audits and self-inspection (through peer-based mentoring, review of reports, on-the-job skills teaching, presentations, etc…)
• Prepare for, conduct, and manage audits (GMP/GDP routine, new contractor assessment, cause, etc.) of third parties utilizing a risk-based approach to audit scope and depth.
• Identify and document risks and gaps to applicable regulatory, ISO, and Haleon Quality System (HQS) requirements.
• Preparation of clear concise audit reports that ensure of identified risks and that appropriate corrective/preventive action plans are implemented to address gaps in systems/processes and/or risks.
• Independently manage the interface with auditees and internal stakeholders in the Business Units and Contract Manufacturing Organization.
• Support of the Haleon Auditor Certification program (either as a trainer or an interviewer).
• Support for cause investigations into serious incidents/product recalls on an as needed basis.
• Support audits of specific risk areas e.g., data integrity on an as needed basis.
• Identify and communicate key learning points through Quality Councils and other forums, including emerging regulatory trends and compliance risks.
• Support the management of Haleon Auditing Quality Systems and associated procedures.

You will manage multiple stakeholders across Quality & Supply Chain using a pro-active mindset and will work with stakeholders to identify and resolve findings with solutions that are fit for purpose and ensure sustained compliance performance.What are we looking for

• Degree (BSc) or equivalent experience in a relevant field.
• Excellent knowledge of European GMP & GDP regulatory requirements for OTC, medicaldevices, APIs, dietary supplements, cosmetics and foods.
• Demonstrated knowledge and experience in performing ISO 13485 audits. Awareness of ISO 17025 Lab Standards, ISO 9001 Quality Systems standards.
• Proficiency with auditing process, both virtually and on site.
• Ability to influence and collaborate effectively with stakeholders at any level of the organization.
• Analytical mind, good attention to details and problem-solving skills within a structured process.
• Concise and persuasive in the description and resolution of compliance risk.
• Understanding of corporate governance processes.
• Working understanding of R&D and New Product Introduction (NPI) practices and requirements.
• Demonstrated application of continuous improvement, change control and risk assessment.
• Available for frequent travels to TPCs and LSPs sites within Europe.

Additional/Preferred experience:Any knowledge / expertise of the below would be a great benefit:

Experience with regulatory/ISO inspections of manufacturing sites from various Health Authorities, such as EMA, MHRA, HPRA, FDA Good knowledge of best audit pr