Job Description

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.Your role: The Quality Assurance Supervisor has primary functional / administrative responsibility for a group of QA personnel who perform a variety of tasks within the Quality Assurance department. Allocates work and monitors progress, timelines, completion and quality. Impacts a range of important customer, operational, project or service activities within the Quality Assurance (QA) team as well as Operations teams. Guides and influences peers and/or senior management regarding quality issues. Contributes to the strategic direction and operational decision-making of the organization. Is accountable for the performance /results of own team. Supervise staff and organize employees' schedules. Assign and monitor work distribution and performance across the QA team using appropriate tools. Provide and/or ensure appropriate training, coaching and professional development for personnel. Provide feedback, complete performance reviews, document performance problems and take appropriate action. Provide compliance / regulatory guidance to other departments in area(s) of expertise. Monitor expenses and resources within department budget. Lead and/or provide support for client audits and regulatory inspections. Lead and/or participate on global quality improvement project teams. Lead and/or participate in projects as global QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.Who you are: Graduate degree in life sciences or higher related degree At least 4+ years of experience in Quality Assurance or related field within a GxP environment. 2+ years supervisory or team lead experience preferred Shows a desire and motivation to work in Quality and regulated environment. Awareness of Biologics regulatory environment and GMP manufacturing topics. A proactive approach to all aspects of Quality. Expert knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity Global mindset and to be willing to engage in conference calls at out-of-office hours.
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