Job description Posted 06 December 2021

Compliance Lead - Change Control

12 Month contract


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