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: 893167-W Type of placement: Permanent Location: North-West London, UK Main Responsibilities:

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:

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

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:

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