Quality & Compliance Manager
- Stevenage, Hertfordshire (GBR)
- £425 - £434.52 Per Day
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00092503
- quality management
- gmp
- compliance
- reporting
- document management
- manufacturing
- documentation
- operations
- continuous improvement
- data analysis
Title: Quality & Compliance Manager
Location: Stevenage
LOA: 12 Months
Pay Rate: £434.52 Per Day Via Umbrella (PAYE option is available )
Description:
Compliance Lead
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 Compliance activities across the CGT platform covering a range of Document Management and Training topics including training administration, metrics, documentation systems and processes and system administration.
• Support delivery of document management systems and processes including the following activities in Veeva Quality Documents (VQD) – editing, controlled printing, reconciliation and archiving
• Support delivery of training systems and processes within MyLearning (MyL)
• Generation of reports and metrics (including trending) from systems including VQD, MyL, Spotfire
• 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 medicines in the pipeline
• The position will involve forming positive and productive relationships internal to our company
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
• Experience with Veeva Quality Document (VQD) or similar
• Experience working in MyLearning (MyL) 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
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 our intellectual property
