Senior Associate for Clinical Quality Assurance (f/m) Job in Monheim 40789, Nordrhein-Westfalen Germany

Description

This position partners with Global Projects and Development, Global Medical Affairs, Global Drug Safety and Pharmacovigilance and GMP Quality Operations in driving quality in the clinical activities across the UCB sites.

It designs and implements a robust clinical quality risk management program that profiles and mitigates risks associated with patient safety, data integrity and regulatory compliance.

Furthermore, it provides direct compliance and investigative support to UCB activities which are regulated by GCPs.

This position will support operations related to global development of new drugs and/or new indications using GXP principles.

Qualification

Minimum of 3 to 5 years of work experience in Clinical QA auditing of clinical programs or with direct clinical development

Good working knowledge of GXP principles relative to the development of pharmaceutical products

Specific skills

ASQ certification or advance clinical degree

In-depth knowledge of worldwide regulations pertaining to GCPs for pharmaceutical products

Knowledge and experience in auditing electronic systems and in 21 CFR Part 11 computer system validation

Excellent writing, verbal, listening and presentation skills

Sound management and organization skills in an environment of rapidly changing priorities

Commitment to quality, integrity, and reliability

Excellent team player attitude and interpersonal relationship skills

Ability to travel nationally and internationally as business necessitates

Analytical and creative problem solving skills

Can apply compliance principles in complex situations

Analytical problem solving attitude with practical working business partner knowledge

Additional language skills (e.g. Spanish, Portuguese, etc.) are a plus

UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2010. UCB is listed on Euronext Brussels.

For more information please visit: www.ucb.com