Manager/Senior Manager Clinical Quality Assurance

Overview

• Provide oversight of Good Clinical Practice (GCP) activities ensuring patient safety, data integrity, and compliance with regulations and standard operating procedures.
• Manage and execute GCP audit plans, including internal processes, clinical investigational sites, vendors, and study documentation.
• Support inspection readiness activities, including Health Authority inspections and risk mitigation strategies.
• Develop and deliver inspection training for subject matter experts and support teams.
• Review controlled documents such as SOPs, protocols, and study-specific plans for regulatory compliance.
• Provide guidance to internal departments and clinical study teams on GCP compliance issues.
• Ensure timely implementation of corrective and preventive actions for compliance issues.
• Evaluate and manage deviation and CAPA processes, ensuring timely completion and reporting.
• Collaborate with executive management to support quality oversight activities.

Key Responsibilities & Duties

• Plan, conduct, and report results for GxP audits, including clinical sites, vendors, and study documentation.
• Train and oversee Clinical QA personnel and contract service providers in audit preparation and reporting.
• Lead inspection readiness activities and Health Authority inspection support.
• Develop and deliver training programs for inspection readiness and compliance.
• Review GCP-associated documents for adherence to regulatory requirements.
• Provide compliance guidance to clinical study teams during development phases.
• Ensure implementation of corrective actions to address compliance issues at sites or vendors.
• Manage deviation and CAPA processes, ensuring timely resolution and reporting.
• Support executive management in achieving quality oversight objectives.

Job Requirements

• Bachelor's degree in a scientific or related technical discipline required.
• Minimum of 7 years’ experience in the Biotech/Pharmaceutical industry, with Quality Assurance experience preferred.
• Strong knowledge of global GCPs, including U.S. FDA, EU, and ICH regulations.
• Proven ability to execute quality goals aligned with company objectives.
• Excellent written and verbal communication skills.
• Ability to adapt to shifting priorities and needs.
• Motivated, committed, and capable of self-management.
• Willingness to travel up to 30% of the time.
• Experience in training and coaching personnel in compliance activities.