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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
RQAP-GCP (Registered Quality Assurance Professional – GCP)
4 Year Degree
The Quality Manager/Associate Director will work closely with internal groups and external clients to ensure clinical compliance with ICH, GCP, FDA and other clinical regulatory agency guidelines, as applicable. Responsibilities include but are not limited to:
a. Create and review company SOPs and cultivate continuous improvement processes and procedure to ensure a robust QMS
b. Conduct internal processes/systems audits ensuring findings are addressed
c. Generate audit reports to project teams, management, and participate in trend analysis to identify and help rectify repeat audit findings.
d. Conduct external clinical investigator site audits and vendor organization audits.
e. Participate in GCP Inspection readiness activities. Provide report to internal or external client on findings and recommendations.
f. Assist in quality assurance and quality control of overall internal compliance, i.e., Regulatory Requirements and Client and CPI SOPs as applicable
g. Ensure continuous improvement of policies, procedures, and training
Bachelors Degree preferably in a scientific discipline with Quality Assurance certifications AND a minimum of four (4) years’ experience conducting Quality Assurance audits of internal process & external clinical site audits (or vendor) in a quality assurance and quality control environment.
Ability to travel 30% of the time; both domestic and international.