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GCP Audit Manager, 12M
- Stand alone GCP Audit Manager
- International business trip opportunities
About Our Client
This company is one of the world's 20 leading pharmaceutical companies. Headquartered in Europe, it operates globally with over 100 affiliates and more than 50,000 employees. The company's key assets of interest are: respiratory diseases, metabolism, immunology, oncology and diseases of the central nervous system. Since it was founded, the company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. Central Tokyo location.
-Being an active member of the Quality division through performing investigator site, internal system, vendor, and product audits.
-Ensure early identification and escalation of quality issues to mitigate risk to the development program.
-Identify areas of risk in liaison with Auditing leadership team and stakeholders and develop appropriate audit programmes.
-Ensure that preventive and corrective actions are identified and followed up.
-Support regulatory inspections as required.
-Support the compliance and knowledge and learning functions.
-Organize and coordinate audits conducted by external contract auditors.
-Ensure audit results are communicated to auditees and management (as applicable) in a timely manner.
The Successful Applicant
-Graduate calibre candidate with a scientific background, ideally in a life science or a paramedical related discipline such as a nurse or pharmacist
-Previous GCP audit experience conducting audits of clinical investigators, vendors, systems or documents, or experience as a senior level CRA or other associated function within a pharmaceutical company, CRO or GCP compliant hospital environment.
-Must have excellent report writing, presentation and communication skills.
■Required Capabilities (Skills, Experience, Competencies)
-Understanding of all phases of drug development (I-IV) and thorough knowledge of GCP as well as quality principles.
-Ability to critically review documents.
-Competence to interact independently with all relevant partners (internal and external).
-Building engagement through collaboration and knowledge sharing.
-Guiding continuous improvement.
-Sound judgement, anticipating future needs.
-Fully understands and adheres to regulations, company standards and procedures.
-Pragmatically tackling complex situations with all levels of the organization.
-Ability to travel internationally as needed.
-Ability to communicate clearly and effectively in writing and verbally.
-Demonstrate excellent interpersonal skills.
-Lead and work well in teams or independently.
-Possess the ability to influence and negotiate with excellent judgment and decision making qualities.
-Able to multi task and manage time efficiently and effectively.
-Strong organizational and prioritization skills, good analytical and problem solving skills.
-Must be able to exhibit independence and maintain the company's best interests in complex regulatory and business situations.
Previous GCP audit experience conducting audits of clinical investigators, vendors, systems or documents, or experience as a senior level CRA or other associated function within a pharmaceutical company, CRO or GCP compliant hospital environment. Understanding of the drug development process, regulatory compliance and QM activities.
Extensive knowledge of regulatory requirements in the area of Good Clinical Practice (GCP), including ICH, EU and FDA regulations.
What's on Offer