For one of our clients in the area of Brussels (North), we are looking for a staff member of the Global Quality & Compliance group, who will provide quality assurance oversight to the R&D clinical, non-clinical and PV programs.
- Do you have a minimum of 3 years' experience in a quality position in the health industry?
- Do you have relevant experience in the audit of GLP or GCP studies?
- Do you have a proven knowledge and understanding of regulatory requirements in this area?
- Are you fluent in English?
If this applies to you, don't hesitate to contact us and/or send your CV!
As a staff member within the Global Quality & Compliance group, you provide quality assurance oversight to the Research & Development clinical, non-clinical and PV programs.
- You are proficient in the understanding of current regulatory requirements in regard to the quality of research for registration of products in major global markets. You are proficient in performing quality assurance audits and inspections of non-clinical and clinical veterinary product studies and reports, including: protocols, data/data listings, summary & analysis, master study files, final study reports, investigator study sites and in-phase inspections.
- You are proficient in performing quality assurance audits and inspections of equipment, facilities, CROs and processes that support non-clinical and clinical product studies.
- You participate in a variety of quality assurance-related activities including staff and project meetings, non-study document reviews, and consultations with VMRD colleagues. You may assume the lead role for various projects within GQC. You provide compliance training to VMRD staff and contractors.
- When requested, you participate in government inspections of clinical and non-clinical studies as well as pharmacovigilance and other inspection types.
- A Bachelor/Masters degree in a scientific or health related field of study.
- Preferrably a relevant advanced degree or training/certificate in Quality assurance.
- A minimum of 3 years' experience in a quality position in the pharma or animal health industry.
- Relevant experience in the audit of GLP or GCP studies.
- Proven knowledge and understanding of regulatory requirements.
- Proven ability to work cross-functionally with other departments.
- Strong written and oral communication skills.
- Ability to work independently and in teams.
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives.
- Ability to analyze data and synthesize to make data driven decisions.
- Proficiency in English.
- Demonstrate knowledge and understanding of regulatory requirements.
- Demonstrated experience managing complex quality and compliance activities in R&D or with a contractor. Prepared to take initiatives with an ability to handle and prioritize issues accordingly as they arise.
- Ability to prioritize workload to act and work independently, a confident decision maker with the ability to recognize significant issues requiring immediate reporting to the Team Leader.
- Diplomatic in communications with internal and external stakeholders, strong negotiating skills and a demonstrated ability to resolve conflict to the benefit of all parties.
- Ability to travel regularly (up to 20%) and independently nationally and internationally.
(015 21 11 04)