Summary of Position:
Playing a critical role, the Sr Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in GCP Compliance with respect to planning, execution and close-out Clinical Studies. The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
This is a high visibility role and will be directly involved in development and continuous improvement of GCP Quality and overall Quality Management Systems at company as we grow and mature organizationally. This individual will be responsible for coordinating with key stakeholders to develop/implement processes and systems governing GCP activities. Position Responsibilities:
Oversight of ongoing compliance of Clinical Studies
• Act as GCP QA Program Lead while working with internal customers to ensure overall compliance from risk-based principles. Provide expert GCP consultation within the organization.
• Work with internal and external GCP customers and develop and execute strategic plans to identify, mitigate, monitor and report study risks and Quality Tolerance Limits on a per study basis.
• Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories and provide assessment of the impact of any deficiencies. Escalate issues through the Quality Organization as needed.
GCP Vendor Audits and Oversight
• Support the GCP Vendor Audit Schedule including CRO, Central and Specialty Laboratories, IxRS/IRT/Randomization liaising with QA Vendor Auditing.
• Coordinate with Study Team members to ensure vendor audits are appropriately scoped and that third-party auditors are provided all the documentation and insights required for successful audit execution.
• Review and approve submitted audit reports. Ensure audits were performed to internal standards. Ensure proposed CAPAs are adequate and executed properly.
Clinical Investigator Site Audits
• Manage the Clinical Investigator (CI) Site Audit program for assigned studies. Coordinate with Study Team members to determine CI sites to be audited per study via risk-based criteria. Coordinate with Study Team members and third-party auditors to ensure CI site audits are appropriately scoped and audit planned.
• Review and approve submitted audit reports. Ensure audits were performed to internal standards. Ensure proposed CAPAs are adequate and track to closure.
• Determine if CI Site audit observations may represent study-wide or program-wide risks and ensure Impact/Risk Assessments and Study-wide/Program-wide CAPAs are adequate.
Quality Management System
• Coordinate with Program Leads, Biostatistics, Data Management, Medical Affairs, Pharmacovigilance to develop/implement Phase appropriate procedures to ensure consistency and quality with respect to Clinical Trial support activities at company.
• Perform internal audits of processes and functional areas to ensure compliance with GCP, internal SOPs and other applicable regulations.
• Coordinate with Senior Management, Functional Area Leads, and third-party vendors, to plan and execute resolution to compliance gaps identified during mock inspections.
Candidate Requirements:
• Bachelor's degree in the Life Sciences with 7+ years in pharmaceutical or biotech drug development. Advanced degree preferred.
• Minimum 3 years of experience in Clinical QA. Experience in auditing both Vendors and Clinical Investigator Sites a plus.
• Demonstrated experience working with clinical trial teams.
• Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements.
• Ability to evaluate and reorganize priorities quickly in a dynamic matrixed setting.
• Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels.
