Job Description
As Operational Quality Manager (OQM) you are welcomed in a smaller, amiable, and enthusiastic QA team where you will have day-to-day interaction with other QA experts in the field, such as other OQMs, Quality Compliance Managers, Auditors, …
As OQM, you will be an indispensable partner of the operational teams - specifically at our Clinical Pharmacology Unit (CPU) in Edegem - in the management of their part of the quality system. As such, you will gain insight into the different investigator site processes applicable for the conduct of clinical trials for pharma and biotech companies from start to finish.
Your responsibilities:
Your main responsibilities are the following:
1. Collaborate with the assigned operational teams at the CPU to improve quality and maintain high quality standards throughout the organization by:Developing and maintaining operational quality (SOPs, WIs, CDs, manuals and various guidance documents) and personnel documentsSupporting the teams by providing additional explanation on topics relating to quality documents/process improvements, development of trainings (eLearnings, classroom trainings) together with the QA training departmentInitiate process improvements / efficiencies were neededGuide the teams through the non-conformance management process by assisting in risk assessment of non-conformances, Root Cause Analyses and formulation of CAPA PlansAssist the teams in performing their daily work in a consistent and efficient way
2. Participate in / facilitate cross-functional discussions and working groups related to any aspect of quality at the CPU, to create or optimize cross-functional procedures, or to look for efficiencies in processes, systems, and collaboration.
3. As assigned, support the further development of the new SGS CR electronic Quality Management System.
Qualifications
What do you need to be successful in this role?!
4. Minimum of 2 years of experience in a site, CRO or university research (department, laboratory) setting, or in a pharmaceutical, biotech, medical devices (or similar) company, or equivalent by combination of education, training and experience
5. Experience in an investigator site setting is a significant asset
6. Affinity with computerized systems and technology in general (including system validation) is appreciated
7. Good knowledge of ICH-GCP and good documentation practices, and experience with project management are a plus
8. Fluently writing and speaking English
9. Excellent communication and problem-solving skills
10. Strong organizational skills
11. Proficient in writing
12. Good knowledge of MS office
13. Assertive and motivated
14. Open for discussion and constructive attitude
15. Strive for quality and eye for detail
16. Stress resistant and flexible
Important note: we cannot support a work permit.
Candidates must already be resident in Belgium!