Responsible for enforcing an efficient and compliant auditing program according to senior management-approved Quality Assurance Operating Plan and company SOPs (Standard Operating Procedures), GxP (e.g. GCP, GLP, GMP, GPvP, GDP, etc.) and clinical trials regulations. Provides expertise on the design, implementation and development of GxP, systems, processes and procedures.
May manage QA auditors’ team to ensure contracted and internal audits are performed, findings reported to management and/or clients, and corrective actions evaluated.
May have responsibility to support specific operations such as:
- Clinical Pharmacology Unit
- Bioanalytical Laboratory
- GMP Pharmacy
- Computerized Systems
- Participates in the selection, hiring and training of new QA staff.
- May functionally manages 1-15Auditors
- Leads QA auditors’ team by providing clear team and individual goals and expectations and ensuring that each member of the auditing staff understands her/his responsibility to know and follow all SOPs and corporate policies
- Performs personally and/or ensures contracted and/or internal audits are completed according to client expectations and/or SOPs and audit plans
- Interprets regulations and guidance documents governing GCP and serves as expert and consultant to staff and client representatives
- Performs personally and/or ensures all new and updated SOPs are reviewed by QA
- Performs personally and/or ensures client audits and regulatory inspections of the company are managed to facilitate the client/inspector expectations and minimize disruptions to ongoing operations
- Researches the published information, interacts with QA and/or regulatory professionals and maintains knowledge of current expectations, new trends, and proposed changes to regulations that may impact internal stakeholders.
- Leads the evaluation and management of site specific escalations related to persistent or serious misconduct.
- Participates, as requested, on GCP related projects initiated by internal stakeholders
- Provides regular status reports on quality observations to Operational Management, as requested
- 5 years experience with auditing, compliance, and SOP development preferred.
- Experience leading or direct management of staff is preferred.
- Must have 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
- Read, write and speak fluent English;fluent in host country language required. Fluency in otherlanguages is a plus.
- An undergraduatedegree or its international equivalent from an accredited institution required. Preferably in the health-sciences or computer sciences.
- Managerial experience in clinical research preferred
- Knowledge of CRO / Healthcare / Pharmaceutical quality assurance activities preferred.