215 First Street
Post Date: 03/05/2018
Job ID: 1867
Job Category: Clinical: Quality
Our client is seeking an Associate Director, Quality Assurance (GCP/GLP). This person will be a creative, resourceful, integrative thinker for an important role that is responsible for GLP and GCP compliance and audit activities.
- Plan and lead GCP and GLP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.
- Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures.
- Ensure compliance with company' s procedures and regulatory requirements.
- 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).
- Review and provide input into non-clinical documentation (e.g. protocols, study reports).
- Facilitate GCP/GLP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
- Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers.
- Provide guidance, interpretation and information on GCP and GLP regulations, standards and quality systems.
- Develop and implement standards, policies and procedures for GCP/GLP regulatory compliance.
- Develop and measure quality metrics to drive consistent quality standards relating to GCP and GLP activities.
- Bachelor’ s degree with minimal 10 years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems related to GCP and GLP.
- Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
- Extensive experience auditing clinical CRO’ s, clinical sites and investigator sites.
- Understanding of domestic and international regulatory requirements.