Job Description
The Clinical Quality Assurance Manager will manage all audits required for the clinical studies conducted and the conduct of internal and external GCP system and process audits. The QA Manager will manage and support quality related activities and systems related to clinical studies and any GCP, or GPVP inspections/audits by Regulatory Authorities.
The Clinical QA Manager will develop, coordinate, and manage timelines for GCP audits of vendor and clinical sites, working cross-functionally to ensure GCP compliance. Develop metrics for Quality Assurance to proactively assess compliance with GCP and help determine compliance risks and to enhance proactive risk-based auditing.
Responsibilities
- Assure inspection readiness by designing an audit program of internal and external compliance audits.
- Support inspection preparation activities and may be called upon to remain with inspector(s) during inspection.
- Assist in the coordination and oversight of audits (e.g., sponsor GCP audits of investigational sites and internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures, and GPVP audits of safety department.
- Perform audits or co-audits as needed to meet the needs of the audit program (these can be co-audits with experienced auditors and also internal audits such as training documentation, OP compliance, etc).
- Author or co-author auditing SOPs, audit report templates, work instructions or job aids.
- Feed information into the tracking tool to be able to provide trends on audits and audit findings.
- Support Risk Management Plans for clinical activities.
- Act as GCP expert and provide expertise, support, and/or respond to questions from clinical staff on GCP/QA questions.
- Identify and mitigate potential clinical quality risks and escalate to management; Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities.
- Ensure adequate resourcing of qualified and experienced auditors is available to meet audit plan; ensure appropriate transition planning and stakeholder communication for any change in staff.
- Manage the contract auditors by helping prepare audit budgets, contracts and onboarding auditors with procedures, processes and IT systems.
- Support maintenance of Quality Systems by reviewing deviations, participating in quality improvement efforts, and reviewing controlled documents and assessments of processes for possible quality and compliance gaps.
- Conduct and/or support meetings with internal teams, functional teams, and project teams, as needed, including meeting agendas, minutes, action items.
- Provide day-to-day department support activities to aide completion of project deliverables.
- Coordinate/facilitate conduct of Lessons Learned initiatives for the department and/or other cross- functional teams as appropriate.
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred.
- Minimum of 7+ years of project management experience in the life-science industry, or proven competencies for this position and a minimum of 3+ years of direct clinical (GCP/GPVP) Quality Assurance experience.
- Direct work experience in a global, cross-functional project management in the life sciences
- Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GxP governing the conduct of pharmaceutical development activities.
- Significant to advanced experience using Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint) required; experience with Project Management Software (e.g. MS Project, SmartSheet)
- Excellent interpersonal skills and demonstrated ability to lead is required.
- Excellent verbal, written, and presentation skills are required.
- Ability to distil and communicate key information to intended audiences.
- Experience in root causes analysis, problem solving, and analytical skills.
- Demonstrated ability to organize multiple priorities and projects.
- Focus on results, highly collaborative cross functionally, and proactive.
- Ensures continual learning and keeps abreast of most recent Agency guidance and industry best practices.
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