A recognized biopharmaceutical organization in California is seeking a Senior Manager for Clinical Quality Assurance to join their team in San Francisco. In this role, the Senior Manager, Clinical Quality Assurance will be responsible for providing oversight of GCP activities, including but are not limited to: ensuring patient safety, data integrity and compliance with SOPs, GCP, and applicable regulations.
About the Opportunity:
Assignment Length: Long-term
Schedule: Monday to Friday
Setting: Hybrid (need to be onsite 2 days a week)
Notes: W2 Candidates
Responsibilities:
Plan, conduct, or manage, and report results for GxP audits, which include but are not limited to internal processes, clinical investigational sites, clinical vendors, CSRs and TMFs
Train, coach and oversee Clinical QA personnel, subject matter experts (SMEs), and/or other contract service provider(s) in preparing, conducting, and reporting of GxP audits, as assigned
Review GCP-associated controlled documents, which may include standard operation procedures (SOPs), protocols/amendments, study-specific documents such as study or data management plans, etc., in accordance with applicable regulatory requirements (e.g., ICH E6, U.S. FDA, EMA, and local regulations)
Provide guidance and support to internal departments and Clinical Study teams (during all phases of clinical development) in the identification and investigation of potential GCP and compliance issues
Ensure appropriate and timely solutions for corrective and preventive actions are implemented at sites or vendors, when needed, to secure compliance and maintain a state of inspection readiness
Perform other duties, as needed
Qualifications:
7+ years of experience in a Biotech/Pharma setting
Bachelor's Degree in a Scientific and/or Technical-related field
Strong working knowledge and interpretation of global GCPs, particularly U.S. FDA / EU and ICH regulations and guidelines
Able to execute quality goals over a 1-2 year period that aligns to company-wide objectives.
Excellent communication skills, both written and verbal
Motivated, committed, and self-managed
Desired Qualifications:
Quality Assurance background