As QA Manager, your mission scope includes following tasks:
- To partner with global Clinical Development, Global Medical Affairs, Patient Safety and other Quality groups in driving quality into the clinical activities.
- To design and implement a robust clinical quality risk management program that profiles and mitigates risks associated with patient safety, data integrity and regulatory compliance.
- To provide direct compliance and investigative support to our activities which are regulated by Good Clinical Practices (GCPs). This position will support operations related to international development of new drugs and/or new indications.
- Demonstrated knowledge and understanding of applicable global regulations, quality principles as well as techniques and trends in the pharma industry.
- Excellent working knowledge of Good Clinical Practices, applicable regulations, and best practices relative to the development of pharmaceutical products.
- 3 to 5 years of auditing experience.
- Proven ability to maintain knowledge of industry trends, benchmarking and best practices
- Master's degree.
- Fluent in English. Any other language is a plus.
What we offer
Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park - Drève Richelle 161 - Waterloo
- Nijverheidslaan 3, - Strombeek Bever