Manager of Quality Assurance Early Development
- Experience Level
For our Quality Assurance group in Europe we are currently recruiting a Manager of Quality Assurance focusing on early phase activities.
You will work closely with internal PRA groups to assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities such as inspection management, internal process audits, pharmacovigilance system audits, study specific audits (e.g. investigator site, in process, pharmacy/distribution, trial master file), country office audits and audits of vendors used to support PRAHS services.
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Organizing and managing the department activities to ensure an optimal realization of corporate policies.
- Provide direction, guidance and leadership.
- Review information and results.
- Intervene when problems arise.
Stay informed and maintaining a respected status within discipline.
- Stay informed of developments in the field of quality, compliance, quality assurance, by reading professional literature, participating in symposia etc.
- Participate in meetings and meetings of quality and compliance associations.
- Participate in giving external and internal quality training
Continuous improvement of the quality of the products within CRO.
- Initiate and participates in working groups and project teams regarding quality improvement programs.
- Advise in case of quality problems (troubleshooting).
- Provide information to employees about inspections, audits, procedures (SOPs), regulations etc.
Location: The role can be based remote in Europe, frequent travel to Groningen, Netherlands, will be required. Short distance to an airport is preferred.
You are an experienced QA professional with intercultural leadership skills and have:
- Experience with auditing, compliance, and SOP development within a CRO environment
- Compliance or auditing management experience
- Thorough understanding of GCP and EC and/or US regulations
- Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies ad clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred
- The ability to read, write and speak fluent English.
- An undergraduate degree or its international equivalent from an accredited institution, preferably in the health-sciences or computer sciences.
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
Find further information on www.prahs.com.
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