Cmo Quality Manager
6 months ago
Hello. We’re Haleon. A new world-leading consumer healthcare company. Shaped by all of 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 building together. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
Job Purpose:
Reporting to the CMO Quality Group/Cluster Leader, as a key member of the Supplier Relationship Team (SRT), this position is responsible for managing the relationship with assigned Contract Manufacturers (CMs) in the Region from a Quality perspective to ensure HALEON’s product quality and reputation is protected.
In this role,
- you ensure that all aspects of the products at assigned Contract Manufacturers comply with the requirements of HALEON Quality Manual and meet relevant cGMP regulatory and legislative requirements, through defined key performance and quality indicators,
- you assess the risk, identify gaps and implement quality action plans at assigned CMs and you communicate to the organization so the risks are proactively addressed.
Additionally, this role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CM(s). These include key contacts with (but are not limited to) Quality, Regulatory, Business Development, Production, Site Management and others.
The CMO Quality Manager in partner with the Supplier Relation Manager (SRM), must develop and maintain an effective working relationship with internal stakeholders and all members of the SRT, including other members of CMO including Supply and Procurement Managers, as well as contacts within Regulatory, Technical, Procurement, relevant Category Quality functions
Job Related Experience:
- Be the point of contact for Quality matters with the assigned Contract Manufacturers.- Ensure that all aspects of HALEON products at assigned Contract Manufacturer(s) comply with the requirements of HALEON Quality Manual and meet all relevant cGMP regulatory and legislative requirements.- Evaluate effectiveness of the CMO’s Quality Unit and systems and influence External Suppliers promoting robust systems under self-sufficient organizations. Escalate all serious cGMP/Regulatory compliance issues. Monitor the quality performance of the External Supplier driving remedial action where necessary. Monitor and assess External Suppliers’ key performance indicators, such as complaints and Right First Time as a mechanism to propose Continuous Improvement initiatives.-
- Ensure that investigations associated with assigned Contract Manufacturers are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure. Support the internal audit process where required.- Ensure timely communication of Quality Alert issues. Co-ordinate and track any remediation deemed necessary. Ensure the LOC (Market QA) is informed as appropriate of any assigned deviations, change controls, audit findings, or complaints which may have impact on product sold in their market.- Drive periodic review of Quality Systems at the CM, to complement audit process. Conduct root cause analysis reviews for identification of issues and development of remedial actions.- Review and respond to External Supplier regulatory inspections on matters that involve activities related to HALEON products. Assess impact of inspection and External Supplier responses to Regulatory observations prior to submission to the associated agency.- Work with CM to establish meaningful CAPAs, in response to HALEON audit observations and assure acceptable closure with the CM. Track and ensure timely and appropriate closure of effective corrective / preventive actions at assigned Contract Manufacturer(s). Take the lead to ensure that any commitments given to address audit observations (both HALEON and Health Authority) by assigned Contract Manufacturer(s) are implemented as described in the agreed time frame.- Ensure that the list of material, products, contract manufacturers and suppliers is constantly up to date in relevant IT database (Veeva).- Support new product introductions from an operational perspective. Eventually review and approve significant documentation associated with the introduction or transfer of a new or existing product to CMs.- Ensure that central database like TIMS are kept up to date for Quality section.- Perform technical release of Medical Devices as per HALEON procedures, if applicable.- Be able to share expertise and functional knowledge to carry out day to day activities effectively on the relevant manufacturing processes (e.g. Solid forms,
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