1. Our client is a top-20 pharmaceutical company which employs 40,000 employees > 20 countries
worldwide. In Europe, the company has marketed products in cardiovascular, central nervous system
disorders and gastrointestinal disease. With R&D facilities in the U.S. Asia and Europe, the company
invests approximately $2bn USD per annum on R&D. European pharmacovigilance, regulatory affairs
and quality management are located in the UK and Germany with selected global responsibilities
within the Group. As part of a program of growth for Europe, we are seeking a Senior Quality
Management Leader who will drive computer system validation projects (documentation,
software/infrastructure). Reporting to the Head of Quality Management Europe, you will support the
development and execution of wider quality management projects in support of clinical development,
regulatory affairs and pharmacovigilance functions. You will already have five or more years’
experience in the pharmaceutical industry of which at least two years must be in computer system
validation and/or development.
Senior Quality Management Leader
Reference Number:
Type of placement:
Location:
893167-W
Permanent
North-West London, UK
Main Responsibilities:
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Assist the Head of Quality Management Region Europe, also in her function as Global Leader
Quality Management, in decision-making processes regarding key areas such as clinical
development, regulatory affairs, pharmacovigilance, Investigational Medicinal Products (IMPs)
und GxP-compliance
Perform computer system validation activities such as:
o Support the creation, review and approval of validation documents (e.g. validation
assessments, risk assessments, GxP/21CFR applicability assessments)
o Accompany routine software/infrastructure lifecycle activities as well as track the
validation status of computerized systems
Support the European and global quality management unit in all activities incl. maintenance
and continuous improvement of all relevant processes
Advise employees and OFRI’s Senior Management on current GxP-standards and regulatory
requirements
Contribute to the maintenance and the compliance of the companies’ internal European and
global quality management systems in key areas such as clinical development, regulatory
affairs, pharmacovigilance as well as IMPs in regards to legal regulations and guidelines
Maintain audit plans for clinical trials and quality systems in cooperation with research
organizations in Europe, Japan and the US
Coordinate, implement and monitor global audit activities according to the audit plan
Review, maintain and update Standard Operating Procedures (SOPs) and Working
Procedures (WPs)
Project-based collaboration with other functions, e.g. IMP Management, regulatory affairs,
pharmacovigilance, etc.
Contribute to the continuous improvement of GCP and SOP trainings
Qualifications and Experience:
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University degree in Biology, Pharmacy or an equivalent degree in natural sciences
At least 5 years of relevant operational work experience in the pharmaceutical industry in the
areas of Monitoring, Quality Assurance and/or Good Clinical Practice
Profound knowledge of ICH-GCP guidelines and related regulations
Thorough knowledge and understanding of computerized systems in the GxP environment
incl. experience in software validation and/or development
Understanding of computer hardware and network/infrastructure requirements

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Very good communication skills in English and German and ability to persuade
Strong team player with good organisation skills and ability to deal with multiple tasks at the
same time
Analytical and creative thinking
Computer literate, especially in the Microsoft Office product range, document management
database skills are required
Our offer:
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Low hierarchical, team-oriented work atmosphere with scope for independence
Support, guidance and training from experienced colleagues within an international, dynamic
and professional environment
Exposure to an interesting and broad range of activities
Competitive remuneration and attractive employee benefits
CTC Resourcing Solutions, founded 1997, is a pan-European specialist staffing organisation with
offices in London, Basel and Munich, providing flexible resourcing solutions to the pharmaceutical
industry across Europe, with contract and permanent placements in clinical development, data
management, statistics, regulatory affairs and medical marketing
Should you be interested in the above position and wish to apply, please send your application with your CV,
quoting the above reference number, to our recruitment team at recruitment@ctcon.ch
CTC Resourcing Solutions, 117 Waterloo Road, SE1 8UL, London, UK
Tel.: +44 207 193 9972
www.ctcresourcing.com
info@ctcon.ch