Quality Assurance Manager (m|f|d)
Our client is a fast-growing biotechnology company and a global market leader with numerous subsidiaries and distributors around the globe. The focus is on bringing cancer treatments and regenerative therapies to patients. The initial focus is on how difficult to treat cancers using CAR-T technology whilst exploring treatments for different Therapeutic Areas.
Your Role :
As Clinical Quality Assurance Manager, you will be responsible for :
Ensuring that clinical trials and pharmacovigilance processes comply with applicable regulatory requirements, industry guidelines, and internal quality standards.Executing assigned GCP and GVP audits in line with the Global CQA Audit Program.Planning and conducting audits of internal processes and procedures, clinical investigator sites, CROs and contract clinical laboratories, clinical databases, and study reports to assess compliance with relevant guidelines, legal requirements and GCP / GVP.Providing clinical teams with advice regarding applicable GCP / GVP and compliance related issues and questions.Assist with regulatory inspections and readiness activities, including preparation, hosting, and follow-up.Supporting maintenance and continuous improvement of Global Clinical Quality System.Support the development, implementation, and maintenance of quality systems within clinical research programs and pharmacovigilance, working closely with cross-functional teams to promote a culture of compliance and continuous improvement.Collaborate with clinical, pharmacovigilance, regulatory, and operational teams to ensure quality standards are embedded throughout the clinical development lifecycle.Create, maintain and review relevant quality documents such as policies, standard operating procedures and other quality records, as well as templates and flow charts.Stay current with evolving regulatory requirements, industry best practices, and QA trends.You will work closely with, and report to, the Director of Global Quality Assurance and represent the client's QA topics in the field of work within the company.The role requires 50% presence on-site and up to 30% travelling.Your Skills and Competencies :
University degree or proven equivalent experience in relevant area, ideally in biosciences or pharmacy.First practical experience (3-5 years) in Clinical Quality Assurance in the pharmaceutical or biotechnology industry with proven experience in GCP / GVP.Knowledge of tools and technologies used for automating workflows and processes (e.g. VEEVA-VAULT, Ennov, SharePoints).Quality-First mindset and good knowledge of EU and FDA GCP / GVP and as well as applicable standards (e.g. ICH GCP).Experience in collaborating with interdisciplinary teams and representing QA topics to internal and external stakeholders.Excellent organizational and analytical skills.Personal responsibility, structured working methods.Strong communication and presentation skills in English (German is advantageous).About GenSearch :
At the very heart of the Life Sciences. We are senior consultants and researchers with a past career in Pharma or Medtech organisations and a solid experience in executive search . Our team spirit, as well as a collective and cross-disciplinary approach to recruitment, ensures the best level of service to our clients. www.gensearch-consulting.com
This job description applies equally to male, female and diverse candidates, regardless of the wording used in the text.