Associate Director, QMS Computer Systems Assurance

Job Summary:

As a key member of the CQA Audit and Inspection team, this position is responsible for leadership, planning, conduct, and reporting of GCP audits to ensure that clinical tasks are conducted in compliance with applicable international regulations, guidelines, and MEI Pharma standards. This role also has responsibility for preparation, management, and follow-up of global Health Authority (HA) GCP Inspections, and provision of quality oversight and consultation at the clinical study or program team level in support of proactive quality management. This individual actively leverages audit/inspection outcomes/trends to affect improvement in clinical trial quality and compliance with MEI Pharma and global regulatory requirements. Responsibilities also include leading and/or contributing to the identification, development, implementation, management, and enhancement of CQA operational processes, systems, tools, and best practices.

Role & Responsibilities:

Audit Planning, Conduct, Reporting, and Follow-up

• Assess/plan and/or perform GCP audits of clinical investigator sites, vendors, internal systems/processes, and clinical documents
• Review and/or prepare timely well-written audit reports and communicate findings to auditees, cross-functional representative, and management
• Assess/review audit report responses and ensure the corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate
• Review/evaluate and maintain/track CAPAs and follow-up with stakeholders to ensure actions are completed
• Lead/perform for-cause audits or other high-profile audits, projects, and/or special investigations to evaluate non-compliance, root cause identification, and report results to leadership
• Lead/participate in audit report review team/process to promote consistent delivery of an optimally impactful top quality report/product

Health Authority Inspection Planning, Preparation, Management, and Follow-up

• Lead/participate in planning/preparation/conduct/follow-up for Health Authority GCP inspections
• Lead/contribute to HA inspection dossier preparation and document compilation/QC
• Ensure creation/maintenance of documents for pre-inspection preparation
• Oversee/conduct/coordinate training for defined SMEs and ensure setup pf pre-inspection preparation meetings for line unit heads and appropriate staff
• Lead/contribute to the assessment of reports and results from Health Authority inspections. Including the associated risks and recommendations, for provision to relevant leadership
• Oversee/participate in the preparation of final response documents for Site Inspections and Sponsor/Monitor Inspections
• Lead/collaborate with other CQA team members to complete inspection follow-up activities within and outside the department, as needed
• Oversee/ensure tracking/maintenance of CQA-managed Health Authorities Inspection data

Clinical Program/Study Quality Support and Consultancy

• Maintain ongoing awareness of program/study issues related to quality, safety, and efficacy
• Provide quality oversight and consultation at the program/study level
• Provide risk identification/mitigation support for potential or identified quality issues
• Leverage audit/Inspection trends and other information sources to support data-driven audit planning and optimize clinical trial quality and compliance via stakeholder education and consultation
• Provide GCP compliance consultation to stakeholders on process enhancements/compliance and quality issue management
• Appropriately escalate any quality/compliance issues to relevant leadership
• Contribute to development/maintenance/provision of GCP and Inspection Readiness training for cross-functional stakeholder

Other

• Pursue/maintain current knowledge of applicable regulations, guidelines, and company standards
• Evaluate the impact of new regulations/guidance documents, as well as audit results/trends on the business and regulatory risks, and provide ongoing guidance to CQA and stakeholder leadership
• Identify, track, trend, and report on key quality metrics and areas for improvement as part of Management Review
• Lead/assess CQA operational processes, identify/support/implement process improvements to enhance team efficiency/effectiveness
• Contribute to the identification and communication of lessons learned from audits and inspections and provide expert advice/information to CQA and Clinical Research & Development staff
• Lead/participate in CQA and cross-functional (stakeholder) process-related initiatives/projects and facilitate/support implementation, as appropriate
• Lead/complete various assignments as directed by Quality Management
• Travel 40-50%, domestic and internationally, as needed

Qualifications:

• Minimum of 8 years of clinical quality assurance auditing and 10 years of work experience in clinical research
• Experience with hosting or participating in regulatory inspections (e.g., FDA, EMA, MHRA) and mock inspection readiness planning and execution
• Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs
• Risk Management or risk-based approach to auditing and monitoring experience highly desirable
• Experience in GLP and/or GVP is a plus

Job Requirements and Education:

• Minimum of bachelor’s degree (or equivalent) in a scientific discipline
• High degree of computer skills including proficiency with Microsoft Word. Excel, PowerPoint, and Outlook are essential and knowledge of other Office applications helpful
• Strong organizational and time management skills
• Ability to prioritize and multi-task successfully in a fast-paced environment
• Responds flexibly to shifting demands and changing priorities, proactively looking for ways to contribute
• Demonstrates attention to detail and high quality while meeting deadlines and commitments
• Collaborates with team members across functions and geographies to get work done while encouraging others to do the same
• Maintains optimism and composure in times of change, uncertainty, or stress
• Excellent verbal and written communication skills including the ability to clearly articulate information and interact effectively with cross-functional team members
• Demonstrates critical thinking, sound judgment, and initiative to solve problems

Employment type

Full time

ADA Notations:

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
• Regular communication (hearing/speaking)
• Lifting up to 25 lbs.
• Routine office duties including computer keyboard use
• Vision requirements include close vision and ability to focus
• Noise conditions range from quiet to moderate