NA & EU Quality Standards & Compliance Lead
NA and EU Quality Standards and Compliance ManagerLocations: Any GSK site in EU or North America The role of North America and Europe (NA & EU) Quality Standards and Compliance Manager is created as the primary contact within the Quality Process & Standards team for the Business Units located in the North America and Europe. The purpose of this role is to lead and collaborate with relevant quality and process expertise to create and publish a fit-for-purpose NA & EU Consumer Healthcare (CH) suite of Quality Standards and processes, adequately maintained with the aim to continuously improve, streamline and simplify the standards and processes for ease of adoption and sustainability by the business units and functions. Key deliverables for this role include the following:Lead and collaborate with relevant Global/NA & EU quality and process expertise to establish and maintain a fit-for-purpose NA & EU suite of Quality Standards and processes. Assure the NA & EU Quality Standards and process are aligned and updated to ensure continued compliance with relevant global and NA & EU specific regulatory and quality requirements. Publish and communicate adequately to ensure that NA & EU Quality standards and processes are well-embedded by the business units and functions. Promote and continuously improve, streamline and simplify NA & EU standards and processes for ease of adoption and sustainability by the business units and functions - in accordance with four principles in the operating model - remove duplication, increase cross-functional collaboration, have a more agile, tailored approach and have decisions being made closer to consumers and customers. Ensure timely publication, deployment and effectiveness of NA & EU Consumer Healthcare Quality Standards and processes. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…Establish a simple, robust and sustainable NA & EU Quality Standards and processes, from creation to publication, maintenance and improvement, following a lifecycle approach. Familiarize and stay relevant with all NA & EU regulatory requirements within the scope of oversight. In conjunction with Quality, Regulatory Intelligence & Advocacy manager, keep abreast of the evolution of quality and regulatory intelligence and advocacy related to quality processes and standards by engaging internal regulatory group, quality advocacy group and relevant external quality standards network, etc. Work collaboratively with the established list of experts to ensure timely review and update of external standards, including regulatory changes/updates and learnings from internal incidents impacting the NA & EU quality standards and processes. Lead and work with the experts to establish and maintain a fit-for-purpose and sustainable suite of NA & EU Quality Standards and processes that is aligned with the most current regulatory and quality requirements. Embrace the four principles in the operating model and lead by example in embedding continuous improvement, simplification and with the intent of both internal and external customers in mind whenever NA & EU Quality Standards and Processes are created or subject to revision. Maintain a well-organised plan as a look ahead for publication to ensure smooth and ease of implementation and effective communication to all impacted business units and functions. In collaboration with the Q Process and Standards Lead and all other peers in the team, promote QMS awareness and adoption beyond Quality functions to nurture a stronger support and adoption with ease by the non-quality functions. In collaboration with NA & EU Quality Champions or experts, identify trends and specific areas of opportunity to drive implementation and effectiveness of the Quality processes. In conjunction with the Q Process and Standards Lead and all other peers in the team, establish relevant key metrics to monitor timeliness of new and revised NA & EU Quality Standards and processes publication and deployment, and periodically review the effectiveness of “In-place and In-use” across NA & EU. Advocate and lead by example as owner or custodian for the assigned quality processes and standards who is responsible to create the content / evaluating the changes to the content of the assigned quality processes and standards, in compliance with the internal and external quality and regulatory requirements. Work with the Quality Process and Standard Lead and peers within the Q Process and Standards team, to rationalize the future setup of the appropriate quality standards and process steering, network meeting/CoP Why you? Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelors DegreeMinimum of 7 years experience in a combination of Quality Management Systems, Regulatory and legal requirements governing the manufacturing and supply of products for NA & EU including the associated supply and receiving markets outside NA & EU and technical writing Preferred Qualifications:If you have the following characteristics, it would be a plus:Masters Degree or PHDAbility to communicate clearly, both orally and in writing, complex themesAbility to influence without direct authority Knowledge about main regulations Good understanding of quality standards, process and compliance that are relevant to NA & EU markets/segmentGood knowledge of highly regulated markets within North America and Europe and their associated regulations such as USFDA, MHRA, Health Canada etc. Ability to connect with different parts of the organisation to establish a network of contacts who could contribute towards the deliverables expected of this roleSome project / programme management skills would be useful
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