Senior Specialist, Continuous Improvement

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Nov 29 2021 Acts as Business Lead Investigator on deviations within Cell & Gene Therapy. The Senior Specialist is responsible for managing all aspects of the internal deviation process within Cell & Gene Therapy including acting as the lead BLI, updating KPIs, communicating to the relevant stakeholders up to and including the Leadership Team with regards to the status and impact of deviations within the department. Additionally, this role may be called upon to complete other operational quality activities such as Change Controls, Management Monitoring, and audit responsibilities. Key Responsibilities: Acting as Business Lead Investigator on deviations within Cell & Gene Therapy Identifying the Root Cause for Deviations, working with key Stakeholders to identify effective Corrective Actions, and providing a timely and concise report on the deviation investigation. Upon request, be prepared to present the report to regulatory authorities and/or members of the Leadership Team. Continuously improving the Deviation Management Process within Cell & Gene Therapy by proactively seeking feedback from key stakeholders, improving the process, and monitoring the process. Proactively improving the R&D Deviation Management Process by being an active member of the central Deviation Team and looking to align R&D with best practices. Surveying external partners and businesses for best practices regarding deviation management and continuous improvement initiatives. Employing the best practices within the CGT space. Providing consistent and direct communication up to and including the Leadership Team regarding the status of the deviations management system, developing trends within the space, and highlighting any risks to the risk management system. Senior Specialist may on occasion also lead Change Controls and Management Monitoring activities. Senior Specialist will actively participate in routine audits, both internal and external. During these audits, the Senior Specialist will be responsible to present the investigations to the inspectors and act as the Subject Matter Expert for the Deviation Management Program. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree in Life Science or Engineering 3 years of experience in process improvement, tech transfer or analytical development within Vaccines, Biopharmaceuticals, or Cell and Gene Therapy Experience initiating and implementing a variety of continuous improvement projects targeting compliance, efficiency, and Cost of Goods (CoGs). After initial implementation of project, working to continue to refine the system to ensure a continued growth of improvement and customer satisfaction. 2 years Experience in a Vaccine, Biopharmaceutical, or Cell and Gene Therapy development and/or manufacturing and/or analytical environment. Preferred Qualifications: If you have the following characteristics, it would be a plus: 3 years of experience in Cell and Gene Therapy. 1 year of experience leading deviation investigations with successful root cause analysis and effective corrective actions. Presentation of deviation reports to regulatory authorities 1 year of experience in leading continuous improvement projects utilizing Lean Manufacturing and/or Lean Lab principles. Broad knowledge of Cell and Gene Therapy manufacturing processes and/or analytical techniques Excellent troubleshooting/problem analysis skills. Strong familiarity with Lean Sigma and Root Cause Analysis methodologies highly desirable. Effective time and energy management with an ability to clearly identify priorities and manage multiple tasks while working in a matrix team environment. Ability to manage a dynamic project workload and evolving priorities suitably balancing demands of individual assets vs. the needs of the overall CGT portfolio. Influences organizational thinking and/or research and development activities by leveraging their scientific or technological expertise. Experience effectively communicating progress and risk updates across extended matrix teams Excellent written and verbal communication skills. The successful candidate must be able to write and present reports to regulatory authorities as well as members of the Leadership Team. Strong interpersonal and leadership skills. Solid team player able to function within a matrix team environment. Capable of working independently with minimal direct supervision. 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. 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