Site Name: RTP, Upper Merion, USA - Massachusetts - Waltham Posted Date: Jun 18 2021 Lead Specialty API, bulk drug substance, analytical testing, drug product, and/or packaging external manufacturing quality assurance operations and compliance activities with leadership and direction of R&D project team(s) and PSC supply, technical and specialty product team(s). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Recommend and handle implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met. Build & maintain positive relationships with external partners whereby influence can be applied & accepted to assure GSK quality standards are met. Establish, implement and sustain an operational quality oversight model in compliance with GSK quality expectations & accounting for contractual complexities & strategic project requirements Supports the governance structure for quality oversight of External Suppliers that assures GSK product follow registered detail, QMS requirements and Specialty External Management Processes Directly leads external suppliers as assigned. Runs activities to ensure on time/Right First-Time testing and disposition of bulk drug substance & finished product manufactured by External Suppliers to meet supply chain demand. Assure quality issues are led to safeguard GSK's patients, ensure business continuity & protect reputation. Support to and lead implementation of quality strategy from the QMS or from project leads as applicable. Where deviations from the above policies or the manufacturing process occur, e.g. registered detail, resolve, mitigate or advance to senior management as judged vital Actively lead records produced by External Suppliers, to ensure timely and appropriate outcomes for Quality and Production systems. Develop or maintain quality agreements by QMS. Assurance that GSK's Quality Management System is applied to External Supply practices through effective Quality Agreements, GSK Corporate audits & delivery of successful regulatory inspections. Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, mentor and identification of specific inspectional risks. 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 for LOCs. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in Science or Engineering 7+ years of previous Pharmaceuticals experience in technical or quality role 3+ years of operational quality or compliance experience Experience in GMP's, FDA, EU and other regulatory agency requirements Preferred Qualifications: If you have the following characteristics, it would be a plus: Thoroughly knowledgeable of cGMP's and applicable ICH guidelines. Decision-making skills. lead work and collaborate within cross-functional teams. Strong verbal, written communication and presentation skills. Able to prioritize and decide appropriate course of actions. Strong Project Management skills. Quality System principles and practical applicable, including emerging expertise in deviations/investigations/CAPA and Organizational Change Leads root cause analysis activities as vital using established tools. Leadership Experience Operational exposure. Prior contractor management experience desirable. Strong interpersonal and influencing skills. Flexibility, ability to adapt and accommodate different/ multiple work demands. Experience of current FDA/EMA validation practices including sterilization, cleaning, performance process qualification, shipping, computer systems, analytical methods. Experience of drug development and clinical manufacturing activities. 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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