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• Bachelor’s degree in scientific or health care discipline
• At least 2 years’ industry experience in a quality assurance or a quality-focused role
• Broad knowledge of the R&D drug development process/pharmaceutical industry
• In-depth knowledge of GMP and/or GLP regulations
• Experience with root cause analysis and managing Quality Investigations
• Experience leading and managing internal and/or external audits/assessments
• Knowledge of equipment/facilities/utilities, engineering, maintenance, and/or calibration
• Experience in change control (MaCC) process
• Strong interpersonal skills
• Strong verbal and written communication skills
• Able to interact with peers, subordinates, and senior personnel in a multidisciplinary environment.
• Able to prioritize and decide appropriate course of actions
An opportunity is available to join a global Quality Assurance team responsible for the quality oversight of both GMP and GLP activities performed by outsourced Service Partner organisations on behalf of Worldwide Real Estate and Facilities (WREF) at all US and UK Pharma R&D sites. This role allows an individual to be empowered to drive global harmonization and efficiencies, define and implement process improvements, and provide expert advice to site operations and support areas on regulatory requirements. This role may be based at Upper Merion or at Ware.
• Provide general QA oversight and consultancy in regards to equipment/facilities/utilities engineering and calibration, laboratory services and GMP cleaning.
• Provide QA oversight of Service Partner quality systems activities including CAPA, risk management, quality alerts and quality metrics
• Review / approve procedural documentation associated with facility operations services provided to GxP areas.
• Conduct and support onsite and remote assessments of external vendors and service providers that supply GxP facilities-related services to WREF to assure that services are in compliance with GSK standards and regulatory requirements.
• Participate in and/or lead internal audits/assessments
• Execute self-inspections/ L1 assessments of QA activities
• Lead and/or provide QA support and approval of internal deviation investigations
• Contribute to the training, education, guidance and influencing of business areas on quality and compliance policy and practices.
• Provide support to multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
• Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK. Represent the group as a primary business contact for specific areas.
• Identify and mitigate compliance risks to GSK
You may apply for this position online by selecting the Apply now button.
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