Site Name: USA - Maryland - Rockville, USA - Massachusetts - Waltham Posted Date: Jun 28 2021 Are you a Manufacturing Professional looking for a challenging opportunity to drive Quality Management System improvement and simplification for your local region while working with Quality Managers across the globe? If so, this could be a great position to explore. Reporting to the Specialty External Manufacturing Quality Director or Quality Manager, this role supports the Biopharm Supply Chain products that are externally manufactured and tested to ensure products comply with GSK Quality expectations, specifications and registered details. The Quality Specialist provides quality and regulatory support to ensure clinical/commercial manufacturing, new product introductions and transfers at external suppliers provide for a timely and reliable supply of quality products. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Recommend and support implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met. Build & maintain trusting relationship with external partners whereby influence can be applied & accepted to assure GSK quality standards are met. Support collection, monitoring and analysis of quality performance indicators of the External Suppliers using quality standards and tools in place to identify/escalate emerging/developing trends Partner with key contacts at the External Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality. Ensure quality and regulatory compliance for new product introductions and transfers by establishing liaisons and performing actions with GSK Regulatory groups and external suppliers to register and maintain product dossiers. Support compliance with QMS and cGMP requirements of external supplier via GMP Audit process. Engage in routine evaluation of risk identification and mitigation process of external supplier and escalate as necessary Engage with External Supplier key contacts to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality. Support creation and maintenance of Quality Agreement Part A and Bs and TTS. • Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, coaching 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 as required by for LOCs. Build & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable. Seek clarification on Roles and Responsibilities to ensure team alignment. Complete role based training as assigned. Communicate on an ongoing basis with the Quality Managers/Director to ensure that potential quality issues are identified and that the support is provided to resolve with appropriate sense of urgency. Support Product Incident Alerts, Stock Recoveries and Product Recalls as directed. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Pharmacy, Science, or an engineering discipline 5 years of Manufacturing/Quality experience in the Pharmaceutical industry. (3 years experience considered for MS/advanced degree) Experience with quality and regulatory of current biopharmaceutical analytical and manufacturing techniques/processes Knowledge and experience of GMP's, FDA, EU and other regulatory agency requirements with an ability to apply to quality and compliance Experience in Technical, Regulatory or QA roles working with API, biopharmaceuticals, sterile manufacturing, or QC laboratory experience Experience with the application of Quality Systems in manufacturing, warehousing and distribution. Knowledge and experience with quality and risk management principles and tools Knowledge of regulatory requirements including biological product and facility licensing requirements Preferred Qualifications: If you have the following characteristics, it would be a plus: Demonstrated problem solving skills. Demonstrated ability to make grade level decisions based on facts and data and application of risk management principles Excellent written and oral communication skills -English Developing presentation skills Developing influencing and negotiating skills Capable of working independently and as a member of cross functional teams *LI-GSK GSKBiopharm_development 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. 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). 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