Sr Associate/Associate Global Quality & Compliance - R&D - Belgium
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Posted on : 20 March 2017
- As a staff member within the Global Quality & Compliance group, provide quality assurance oversight to the Veterinary Medicine Research & Development (VMRD) clinical, non-clinical and PV programs.
- Be proficient in the understanding of current regulatory requirements in regard to the quality of research for registration of animal products in major global markets.
- 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.
- Be proficient in performing quality assurance audits and inspections of equipment, facilities, CROs and processes that support non-clinical and clinical veterinary product studies.
- Participate in a variety of quality assurance-related activities including staff and project meetings, non-study document reviews, and consultations with VMRD colleagues.
- May assume the lead role for various projects within GQC. Provide compliance training to VMRD staff and contractors.
- When requested, participate in government inspections of clinical and non-clinical studies as well as pharmacovigilance and other inspection types.
- Bachelor/Masters degree in scientific or health related field of study
- Relevant advanced degree or training/certificate in Quality assurance preferred
- Minimum 3 years' experience in a quality position in pharma/animal health industry
- Relevant experience in the audit of GLP or GCP studies
- Proven knowledge and understanding of regulatory requirements (ideally including Animal Health).
- 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 (ideally including Animal Health).
- 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
- Fully qualified driver in order to visit other study sites
- Ability to travel regularly (up to 20%) and independently nationally and internationally
- Our company is a global animal health company dedicated to supporting customers and their businesses in ever better ways.
- Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services.
- We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.