Director Quality Assurance GCP

NyonFixeChimie, Pharma, Biotechnologie2019-01-11Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Director Quality Assurance GCP

Responsibilities:

• Formulate GCP compliance strategy and provide advice for all programs in collaboration with key stakeholders
• Develop, implement, and maintain Quality Management Systems and SOPs for Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)
• Provide compliance guidance to audited parties and serve as an expert in the interpretation of GCP and GLP regulatory requirements and expectations
• Manage QA reviews of essential clinical study documents as well as regulatory authority inspections
• Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures
• Plan and lead GCP and GLP compliance audits, develop and prioritize audit strategies, and report audit findings and recommendations for resolutions to the management
• Ensure appropriate evaluation of CROs and other clinical service providers as part of the vendor selection process

Profile:

• Advanced university degree in Sciences
• Several years' relevant work experience in GCP compliance in the pharmaceutical industry
• In-depth knowledge of and ability to interpret and apply GCL, GLP, EU, FDA and ICH regulations, guidelines, and best practices
• Proven track record in planning GCP and GLP audits
• Experience reviewing and auditing study-related documentation and with regulatory inspections and quality management systems
• Team player with strong critical thinking and decision-making skills
• Excellent organizational, computing, negotiation, and communication skills
• Fluency in English; German and/or French would be assets

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La référence de cette offre est JN -012019-294586 - HAID

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