Clinical Quality Assurance - Manager

LifeCycle Pharma A/S (LCP) has now reached a point where they need to strengthen the quality organization as they move more projects into the late phase clinical development.LCP has its main premises in Hrsholm, Denmark but has also established an office in the US to support clinical development and regulatory affairs.LCP have made strong progress during the past years, and last year they received the first FDA approval of the product FenoGlide.Currently LCP has 90 employees in Denmark and 20 employees in the US. The Quality Department has broad contact with internal colleagues and also to the contract partners.They believe in an informal tone and a rapid, but highly qualified turnaround of questions and documents.You will be a key person in the QA-knowledge pool.The main objective of this position is to secure documentation of clinical development studies in compliance with GCP by coordinate audits of clinical sites as well as internal audits.Participation in improving the quality system covering the clinical area according to internal and external procedures will also be the focus of this position. Key Responsibilities: * Setting the standards for the quality system in the clinical area and contribute to continue the establishment of a clinical quality system internally in LCP * Actively seek the close daily cooperation with the Clinical Development department and contribute to approval of critical documents in the clinical development process * Coordinate and follow up on audits at the CRO according to appropriate regulatory GCP standards * As a GCP auditor to plan, execute and report on audits of CRO * Writing and reviewing standard operating procedures as a part of the quality system * Trouble shooting in case of quality issues Qualifications: * MSc in pharmacy or similar academic background * At least five years experience in a quality assurance function from a Pharma company * In depth knowledge and practical experience in conduction of clinical studies preferably from clinical audits * In depth knowledge of European and US GCP regulations * Preferably competence as Qualified Person * Strong interpersonal and communication skills * Write and speak English effortlessly In LCP you will be part of a team of colleagues, working across the organization, country borders as well as across nationalities.LCP have an informal and positive working culture, however very focused on achieving their objectives.LCP have a business model with focus on creating rapid results.The position demands some business travel activity in Europe and US. As we call candidates for interviews continuously, we ask you kindly to send your application as soon as possible.About LifeCycle Pharma A/S ("LCP"): LCP is an emerging specialty pharmaceutical company that, through innovative technologies, is able to rapidly develop a portfolio of differentiated products to meet the unique needs of key therapeutic markets and patient populations.This includes products for immunosuppression, specifically organ transplantation, and to combat certain cardiovascular diseases.By using its unique and patented del