QA Manager, GCP/GLP
Direct Hire - REMOTE
The QA Manager, GCP/GLP will report to the Director, GCP Compliance and will be responsible for assessing Good Clinical Practice (GCP) compliance of sponsored studies with the established guidelines for applicable regulatory standards (i.e., FDA, MHRA, EMA, TGA, Health Canada) as well as company policies/procedures.
What You Will Dive Into:
- Responsible for the planning, conducting, and reporting GCP audits: vendors, investigational sites, documents, Processes, etc. as relative to GCP/GLP activities as the clinical study sponsor:
- Create, and maintain Quality Assurance Plans (QAP) for assigned clinical trial and programs, under the direction of line manager.
- Update internal audit tracking systems and auditing metrics.
- Collaborate with QA GCP/GLP colleagues on audit activities to ensure completion of the audits per planned timelines.
- Monitor and effectively drive quality issues to resolution. (e.g., Closure of Audit Reports, develop and track post auditing corrective actions plans, as applicable.)
- Provide QA guidance to the operational teams on current pharmaceutical regulations and ICH guideline requirements for Good Practices: clinical, laboratory, pharmacovigilance, documentation, etc.
- Participate in the regulatory inspections as a member of QA team.
- Work in conjunction with other QA teams to ensure proper representation throughout the organization, as needed.
What We Expect:
- Bachelor’s degree preferred in related scientific field
- Ten (10) plus years' experience in a role of GCP auditor, including leading audits and understanding a risk-based model
- Experienced in conducting GCP audits within Phase I and Phase 2 programs trials, Phase 3 is a plus
- Working knowledge of drug development and clinical research, including extensive knowledge of US FDA regulations and ICH GCP, as well as working knowledge of global regulatory requirements
- Knowledge of electronic systems as the auditor and as a user, including document management systems
- Industry experience in clinical research such as data management, clinical monitoring, safety surveillance, or being a study coordinator is a plus
- Experience supporting Regulatory inspection is a plus
- Able to solve problems innovatively, compliant with ICH GCP and quickly while considering possible implications of the decisions made; good judgment/analytical thinking: Able to differentiate between critical and non-critical issues and to then initiate the appropriate steps
- Demonstrate project leadership and interpersonal skills
- Able to follow existing processes and able to identify process improvement opportunities
- The ability to work in a team-based environment, both independently and as part of a team
- Able to multi-task effectively
- Able to communicate clear and efficiently, in diplomatic style
- Ability to travel domestically and internationally (up to 40% during peak workloads)
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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