Job description Posted 01 April 2022

Compliance Lead

Contract until September 2022

Up to £425 per day via umbrella

Remote / Stevenage

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 be to write Procedures and other compliance-related documents to support Inspection Readiness Activities for CGT staff working within the Catapult Facility, located at GSK Stevenage R&D Hub Site.

• Support delivery of documentation including the following activities in Veeva Quality Documents (VQD) – editing, controlled printing, reconciliation and archiving

• Management of document management and training queries from CGT platform

• Escalating for awareness, consideration and action concerns/ risks which may impact or disrupt delivery of documentation

• 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

• 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 and Quality Management System (QMS)

• 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 Veeva Quality Document (VQD) 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