Senior Clinical Quality Consultant
Danvers, MA | Contract
The Senior Clinical Quality Consultant is responsible for providing expertise and guidance related to relevant and current GCP regulations and guidelines, as well as expertise in CAPA prioritization, development and execution.
This role will develop and evaluate relevant metrics, proactively assess potential risks and recommend mitigating / remediating actions to the Quality Systems Director and other stakeholders within Clinical Operations. Manages framework for Clinical Operations Quality Management System (QMS); provides risk evaluation and consultation on compliance issues. May also lead in inspection readiness and inspection management activities as well as the development of associated processes to enable Clinical Operations to be in a steady state of inspection readiness.
Principle Duties and Responsibilities:
- Provides strategic direction and advisement to clinical study management teams related to GCP risk, including the identification and prioritization of risks and the definition of mitigation plans
- Lead inspection readiness activities working in collaboration with Clinical Operations staff; May serve as inspection host during inspections and oversees overall conduct of inspections.
- Define and ensure visibility & interpretation of predictive risk indicators and quality metrics as they relate to internal process and outsourced third party activities
- Maintain contemporary knowledge of the evolving regulatory expectations and global environment that impact the business to proactively manage risks and increase the robustness of business processes and decision making
- Act as a point of escalation for emergent quality issues relating to clinical trials
- Responds to Request from Regulatory bodies for supplemental information or clarification of existing submittals.
- Assist management on departmental projects, as necessary.
- Other duties as specified.
- Bachelor Degree or equivalent required
- 5-10 years of related work experience desired; Medical device experience preferred
- Previous experience in quality assurance and risk management areas, including root cause analysis
- Excellent verbal and written communication skills
- Strong organizational skills; must be detailed-oriented
- Ability to execute tasks in a timely manner under general supervision
- Strong knowledge of Microsoft Office Suite and Adobe Acrobat