Senior Quality Specialist II, GCP/PV/REMS Quality

Job Description

Job Summary

Responsible for the execution and support of quality programs and oversight of daily quality assurance activities supporting Pre-Clinical, Clinical Research, Medical Affairs, Pharmacovigilance and Regulatory department activities, and other regulated activities related to compliance with federal regulations and company standards

Principle Responsibilities

• Support inspection readiness through development and execution of a comprehensive annual Good Clinical Practices, Good Laboratory Practices, Pharmacovigilance, and Risk Evaluation and Mitigation Strategy (“GCP/GLP/PV/REMS”) audit plan covering internal processes, vendor services and clinical site activities.
• Lead/manage the execution of defined audits utilizing internal/external resources in a cost efficient and effective manner. Ensure post-audit activities entail timely follow-up and resolutions.
• Support the planning, coordination, training, and management of resources and processes for the regulatory inspection . Ensure appropriate oversight of inspections at CROs, investigator sites, and CMOs supporting development programs.
• Host/Co-Host regulatory inspections at the Stamford facility.
• Collaborate with senior management and relevant stakeholders on corrective actions resulting from audits and regulatory inspections. Lead/manage efforts for verification of necessary completed corrective and preventative actions ensuring that compliance risks are satisfied.
• Ensure pharmacovigilance activities including safety information processing and reporting follow regulations.
• Provide guidance on quality and compliance matters to internal customers and external contractors according to regulatory requirements, guidance documents
• Oversee the investigation/deviation/CAPA process for area of responsibilities and facilitate, as needed, to achieve appropriate resolution of points of contention.
• Ensure overall compliance, identify compliance gaps and ensure they are mitigated in a timely manner.
• Ensure project timelines accurately capture all quality activities.
• Review plans and materials for compliance, and contracts/proposals to ensure they adequately capture outsourced QA requirements.
• Lead continuous improvement and remediation for areas identified by audit/inspection and CI team initiatives.
• Lead the quality support role for all post marketing studies, (including epidemiology, noninterventional and required pediatric studies) to ensure they are conducted in accordance with regulatory and company standards.
• Remain current on regulatory expectations and best practices through constant monitoring of changes to regulations, guidance documents, and industry trends related to clinical; safety and regulatory reporting.

Education and Experience Requirements

• BS required and 8 years minimum experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 6-10 plus years’ experience or PhD with 3-6 plus years’ experience.