Associate Director, Quality Assurance

Responsibilities:

• Be responsible for overall QA of Luye’s Global Clinical Development Program.
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  Provide guidance, interpretation and information on GCP/ GLP regulations, standards and quality systems to various functional areas.
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  Develop and implement SOPs, standards, policies and procedures for GCP/GLP regulatory compliance.
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  Provide guidance for regulatory inspection readiness activities and lead CAPA activities.
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  Develop and measure quality metrics to drive consistent quality standards relating to GCP activities.
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  Plan and lead GCP/ GLP audits (international and domestic), including clinical investigator site, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.
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  Assess GCP/ GLP compliance risk areas (internal and external) and develop and implement risk mitigation measures.
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  Ensure compliance with company's procedures and regulatory requirements.
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  Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
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  Review and provide input into non-clinical documentation (e.g. protocols, study reports).
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  Facilitate GCP/GLP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
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  Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers. 

Requirements:

• BSc (minimum) in Life Sciences related relevant discipline.
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  Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research.
  
• Minimum of 10 years’ experience relevant experience in the FDA and/or EU regulated pharmaceutical environment.
  
• Ability to accurately interpret and apply regulatory expectations for a robust and compliant GCP.
  
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
• Demonstrate effective oversight of outsourced activities.
  
• Excellent leadership and communication skills (both verbal and writing).
  
• Strong organizational skills with problem solving and team building skills
  .