Quality System Manager

Company: GlaxoSmithKline
Location: Warren
Posted on: November 23, 2021

Job Description:

Site Name: USA - New Jersey - Warren, Guayama JV, Saint Laurent Montreal, USA - Missouri - St. Louis, USA - Nebraska - Lincoln, USA - New York - Oak Hill Posted Date: Nov 16 2021 The Quality System Manager provides leadership, governance and direction by defining opportunities for system deployment, process automation and transformation of quality system programs (MERP, CERP, SLIM, VEEVA etc.) within the North American CH business units. The purpose of this role is to set the system governance and define user requirement specifics for the globally deployed systems and processes. In collaboration with the Data & Digital Solutions quality team, develop, establish and deploy fit-for-purpose systems and solutions while ensuring adherence to regulatory requirements and defined business expectations. Ensure that applicable quality standards clearly defined system activities and these defined standards are understood and consistently applied in the NA quality organization. Ensure the NA quality system strategy and KPIs is developed to be fit-for-purpose and to help driver further market performance. This role requires a strong working relationship with the Data & Digital Solutions and the Quality Standards & Compliance central quality teams; to enable a productive working environment and ensure relevant standards, guidelines, and processes to deliver our NA quality plan objectives. To drive education and awareness of systems and programs, this role requires close collaboration with NA Tech team, system owners, Site Quality Heads, as well as retaining a targeted expertise group for input and review of systems and processes. Standards & Guidelines: To act as the main point of contact between the Central Data & Digital Team and the local NA system champions for effective communication of existing, new or upgrades to systems or system process requirements. Define the NA user requirement specifics and business expectations for globally deployed systems and processes. Create business cases for resources, when applicable, to deliver on tech transformations and ensure that the delivery is planned and operates as needed. Tracking, monitoring and communicating on projects in flight and ensuring that they are evaluated and updated to keep up with the relevant quality process, regulatory changes and compliance with the internal and NA external regulatory requirements. Quality, Risk & Compliance: Accountable for ensuring proper identification, escalation and cascade of the system process risks. Provide regular reports on progress against risk remediation and gap closure action plans and ongoing KPIs for Quality Council reviews. Support the development of timely resolutions to rectify issues encountered that may result in operational failure, delays or compliance risks. Support the development, and where relevant, the implementation and execution and monitoring of the NA Quality Plan and Yearly Operating Plan Setting with a focus on system processes. Share and publicize achievements and system implementation successes, recognizing in conjunction with the QLT. Processes & Tools: Defining road map of short, medium & long-term plans to drive tech transformation across the NA quality organization. Create and lead cross functional steering team of data owners to ensure the platforms and processes are connected within the organization without overlap. Embedding continuous improvement and simplification through review of existing business processes that are pain points and identify areas that can benefit from automation and/or process improvement. Engage as Quality Lead for transformational projects, system process changes that impact the wider quality and supply chain organization, as appropriate. Making sure that the customer/consumer's voice is represented and presenting the NA quality leadership teams with experience feedback. Education & Awareness: Establish and maintain, as needed, a network of Subject Matter Expert's across NA and global system champions to engage them in the system processes, as well as to share learning's and best practices and support on improvement initiatives. Ensure close collaboration with all quality teams to align on quality reporting and oversight for system KPIs or metrics, and trends related to Data Integrity from audit, inspection, and/or deviations/issues to leverage learnings and best practices. Separation Activities: Support global defined archival solutions, ensuring NA user access requests and matrix are simple, robust and easy to maintain for ease of data retrieval and recovery to support inspections and audits. Ensure guidance and training materials are readily available, simple to use, and assist the users in initiating and executing their records with ease. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Bachelor's degree * 5 + years' experience in a quality, engineering, supply chain or technical role in a pharmaceutical, healthcare, or consumer goods industry * Experience in FDA and/or Health Canada inspections Preferred Qualifications: If you have the following characteristics, it would be a plus: * Master's 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. * Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. * Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. * Budgeting and forecasting, commercial and financial acumen. 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Keywords: GlaxoSmithKline, Elizabeth , Quality System Manager, Executive , Warren, New Jersey