Compliance Lead (CW) Grade 7
The vision for the Cell & Gene Therapy Platform has been to develop an end-to-end organisation, integrating discovery, development and supply functions. This ensures that ground-breaking Cell and Gene Therapy medicines are seamlessly and expertly discovered developed and manufactured for clinical development and beyond. Organisationally the Cell & Gene Therapy Platform is composed of 5 functions: Syn Bio, Discovery Research, Process Development, GMP Operations and Systems / Quality & Risk Management.
This role will support Change Control Compliance activities across the CGT platform.
· Support delivery of Change Control systems and processes including assessing proposals for completeness/compliance with procedure and tracking approvals as part of the CGT Change Control Panel approval
· Follow up on overdue Change Control actions and deliverables
· Support CGT Change Control Process Owner in administration of Change Control Panel meetings
· Generation of reports and metrics (including trending) from systems including C3 QWF
· Management of change control queries from CGT platform regarding process and system
· Support the CGT platform in transition from QWF system to VQMS system
· Escalating for awareness, consideration and action concerns/ risks which may impact or disrupt delivery of medicines in the pipeline
· The position will involve forming positive and productive relationships internal to GSK
Why you?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
· B.Sc. And or relevant industry experience
· Experience of Change Control in the Pharmaceutical Industry/GMP environment
· Strong skills in Microsoft Office applications (formatting Word documents and working in Excel)
· Must be strongly engaged in continuous improvement
· Knowledge in Good Manufacturing Practices
· Understands function operating procedures and/or internal policies required to maintain quality standards and to protect GSK intellectual property
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
· Experience with Carisma 3/Quality Workflow, Veeva Quality Management System (VQMS) or similar
· Must be able to work in a team oriented, fast paced environment
· Must be able to quickly respond to changing priorities
· High focus on customer service
· Ability to closely monitor and communicate progress on daily tasks and responsibilities to Management.
· Excellent organizational and time management skills
· Demonstrated ability to understand and appreciate the value of diverse perspectives and drive innovative solutions to complex problems
· Excellent attention to detail, with the ability to operate at both a detailed and summary level, and to put data analysis into context by seeing the bigger picture, to spot trends and extrapolate
· Excellent interpersonal and communication skills, adept at working with management at all levels and different geographies within the organization in both a matrix and direct reporting structure