Quality Manager Person in Plant

Site Name: Korea - Seoul Posted Date: May 23 2022 Job Purpose This individual will be the face of GSK quality at key, strategic suppliers, CMO’s, and/or alliances. He/she will be accountable for implementing governance of and maintaining these relationships based on transparency and trust. He/she will provide the on-site Quality and compliance oversight of production activities (specialty API, bulk drug substance, analytical testing, drug product, packaging) in order to ensure GSK standards are met, to safeguard GSK’s patients, to protect GSK’s reputation, and to secure the BioPharm and oncology clinical and commercial supply chains. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Key Responsibilities Responsible for building and maintaining the direct Operational Quality oversight and management of relationships with strategic partners, alliances, and external suppliers. This includes, but is not limited to records review and approval, authoring and executing quality agreements, implementing governance, audit support, etc. Leveraging a strong relationship built on trust and transparency, coach, mentor and influence suppliers in order to increase quality mindset and maturity to safeguard the GSK patients, the quality of our products, and our reputation. Facilitate decisions concerning the quality of material and subsequent disposition; escalate issues and risks that may have an impact on supply in a timely manner. Identify and advance continuous improvement initiatives in order to ensure GMP expectations are met. Assure all quality issues are communicated and managed to GSK leadership in a timely manner; proactively identify and manage issues to ensure business continuity; work to quickly investigate and resolve to emerge Assure externally-made products are produced in compliance with registration details, GSK QMS requirements, and Specialty External Management Processes. Where deviations occur, resolve, mitigate, or escalate to senior management as necessary. Work with partners to ensure on-time/right-fist-time production, testing, and release of GSK products to meet supply chain demand. Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, coaching, and identification of specific inspectional risks with a goal of continued inspection readiness. Support Product Incident Alerts, Stock Recoveries and Product Recalls; Serve as Issue Management/Product Incident Recall Committee Secretary. Report and drive resolution of cGMP/Regulatory compliance issues. Request required legal documentation such as Certificate of Pharmaceutical Products (CPP), GMP certificate, Legalized and Notarized Declarations, and documents as required by LOCs. • Build and maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply, and Service Level Agreement as applicable. Contribute to the evolution and implementation of GSK Quality Standards, the annual quality plan, and the overarching quality strategy Establish and maintain a regular dialog with team members, individually and collectively, providing feedback and recognition. Monitor the training status of direct reports Effectiveness with me measured by in-place/in-use Quality Agreements, GSK Corporate audits, delivery of successful regulatory inspections, and quality KPIs Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 10+ years of previous Pharmaceuticals industry experience in technical or quality role(s) with at least 2 years of API, biopharmaceuticals or sterile manufacturing/or QC laboratory experience Sound understanding of quality systems and quality control processes +3 years of operational quality or compliance experience or other relevant experience Demonstrated knowledge of GMP's, FDA, EU and other regulatory agency requirements with an ability to apply to quality and compliance Demonstrated knowledge of quality system principles and practical applications Demonstrated knowledge and ability to apply quality and risk management principles and tools Demonstrated problem-solving skills Demonstrated ability to make grade level decisions based on facts and data and application of risk management principles Experience with work-related travel Excellent written and oral communication skills -English. Proficient presentation skills Preferred Qualifications: If you have the following characteristics, it would be a plus: Proven ability to function independently, as a self-starter, and prioritize work Thorough knowledge of cGMP's and ICH guidelines; demonstrated ability to implement these guidelines Demonstrated sound decision-making skills Demonstrated ability to lead work and collaborate within cross-functional teams (matrix management) Strong verbal, written communication, and presentation skills Strong Project Management skills Solid understanding of Quality System principles and practically applicable, including emerging expertise in deviations/investigations/CAPA and Change Management Demonstrated problem solving capabilities, with preference to direct experience in the application of Excellence in Deviation Management (EDM), Human Factors Analysis, and/or GSK Production System (GPS) principles Prior contractor management experience is desirable Strong interpersonal and influencing skills. *LI-GSK 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. *This is a job description to aide in the job posting, but does not include all job evaluation details. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. 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