Director Of Gcp Quality Assurance

Remote | Must be located in the U.S. | Must be willing to travel internationally

The AD of Quality Assurance GCP will provide expertise and guidance on Good Clinical Practice (GCP) applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation. Will independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners and internal systems in compliance with GCP and Company policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. They will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready.

Essential Duties and Responsibilities:

• Develops and implements relevant clinical QA standard operating procedures
• Clinical investigator site audits to assess adherence to the Study Protocol and associated documents, the Study Audit Plan, applicable regulations, guidance/guidelines
• Leads and/or participates in the company preparations for regulatory inspections.
• Manages and conducts quality system audits of GCP vendors that have been contracted for clinical trial activities and clinical trial data generated to assess adherence to applicable regulations, guidance/guidelines
• Internal trend analysis of audit observations; identifies and communicates to QA management all compliance risks
• Ensures that the GCP Vendor Audit Schedule is created and approved by management
• Represents QA on the clinical and non-clinical teams and provides compliance advice and guidance

Job Qualifications:

• Experience preparing for and participating in GCP regulatory inspections.
• Working knowledge of quality risk management concepts
• Extensive knowledge and/or awareness of ICH GCP regulations and guidance for clinical and nonclinical development.
• Experience auditing GCP vendors, internal GCP processes and documents and clinical investigator sites
• BA/BS degree required; advanced degree.
• Advanced knowledge in the conduct and reporting of audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and the clinical programs.
• At least 10 years of QA a GCP setting for all phases of clinical trials in biotech or pharma GCP setting
• Knowledge of global regulatory standards and associated guidance’s/guidelines