CH Serialisation Quality Lead

GlaxoSmithKline ,
Brentford, Greater London
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Overview

Job Description

Open Location As the Quality & Supply Chain (QSC) Serialisation Quality Lead for the Consumer Healthcare (CH) organization, you will be responsible to ensure the recommendation for the future CH serialisation operating structure is compliant to the QMS and regulatory requirements, inclusive final recommendation on technology solution. In parallel, this role will support the legacy Pfizer sites in delivering compliant serialisation solution during the on-going implementation phases partnering with the CH QSC Serialisation lead. This role defines and supports the CH Quality requirements for the CH New Company and provides direct central support to the manufacturing sites and distribution sites through systems compliance expertise. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Establish and agree operational quality requirements and standards, with clear roles and responsibilities, for the CH serialisation business processes across the supply chain. * Engage with sites and functions to ensure implementation of the agreed business standard process and relevant monitoring as well as quality performance programme. * Identify and work with the appropriate Quality representatives from the supply chains (SQDs, LOC Quality) to ensure that the agreed business process requirements are met. * Work with the QSC Systems leads to develop a quality capability matrix for the supply chain and ensure a training programme is deployed and delivered to sites and functions. * Act as Quality Systems SME to support the business in Quality investigations opened at manufacturing sites and in the supply chain for issues around serialisation in partnership with the QSC Serialisation lead. * Provide operational Quality input, interpretation and approval for business process decisions being made for the definition of the CH serialisation operating model. * Work with the other business partners such as Packaging and Artwork leads to identify areas of synergies and optimisation and efficiencies across the supply chain to define the relevant quality operating model for quality oversight of overall packaging and serialisation compliance. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Science Degree or Experience in pharmaceuticals, manufacturing and quality operations * Knowledge of regulatory, GMP, GDP and GSK quality requirements and ability to explain these and relate to CH supply chain and apply good business judgment in doing so. * Knowledge of validation standards required to ensure quality standards are met * Awareness and understanding of business environment and ability to build networks within the supply chain and support functions * Good influencing and negotiating skills to ensure implementation of appropriate standards, specifications and agreements. * Good verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective actions are put in place. * Strong Operational Quality experience within manufacturing (packaging) or supply chain (QP * Demonstrated ability to function effectively in a complex matrix organization * Good influencing and negotiating skills to challenge the definition an implementation of an effective compliant operating model for serialisation across the CH supply chain. * Strong game changer with ability to drive clear ownership across supply chain including quality organisation * Some knowledge of systems validation and compliance required as collaboration with e compliance teams and Tech teams will be required * Coaching and mentoring skills * Appreciation of, and ability to work across, differing country and company cultures. * Entrepreneurial focus to ensure continuous improvement of the business Preferred Qualifications: If you have the following characteristics, it would be a plus: * Higher degree Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translat

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