Quality Assurance Specialist, Clinical Trials

Job Description:

In this pivotal role as a Quality Assurance Specialist for clinical trials, you will be responsible for driving quality by maintaining a clear line-of-sight for assigned clinical trial programs/protocols. You will leverage deep knowledge of GCP quality and risk management principles to asset and study teams.

You will work in partnership with cross-functional study teams and functional lines to ensure program and study level quality oversight, drive quality risk management and inspection readiness activities, and ensure that asset and study level information is incorporated within the GCP QMS.

You will serve as the point person to the cross-functional study team and other stakeholders for quality risk management, quality issues management, and general GCP guidance.

Key ResponsibilitiesAsset-Level Quality Oversight

• Ensure clinical development plan strategy and asset-level risks are incorporated into study and asset-level risk management and oversight to support GCP Compliance.
• Utilize quality measures/data to monitor asset/study quality and identify potential risks, quality trends, and support state of quality reporting.
• Communicate key quality information across study teams and serve as GCP quality expert to study teams.
• Monitor submission risk and flag major risks for Category Quality Head review and other key stakeholders for review.

Study-Level Risk Management Plan Development and Oversight

• Oversee study-level quality risk management activities, including driving Study Risk Profile development/maintenance and QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner.
• Develop and present quality point of view at governance and portfolio-related meetings.

Inspection Readiness, Preparation, and Support

• Provide Study Team Inspection Readiness (IR) guidance and support to asset teams and pivotal study teams that have a high likelihood of regulatory inspection; lead teams through pre-submission IR deep-dive and storyboards.
• Develop and maintain inspection readiness tools and processes.
• In conjunction with IMQA, coordinate business line GCP inspection support activities, including but not limited to requests for dossiers, pre-inspection requests, during inspections, and through the development of written responses to findings.

Business Development

• Represent GCP quality on due diligence teams for business development opportunities.
• Be the GCP quality representative on integration teams responsible for identifying key quality risks and proposed mitigations and incorporating into study level risk planning.
• Provide strategic input to risk-based quality approaches.
• Perform Quality Integration activities, including representing quality functional lines at integration workshops or operational workshops, facilitating GCP Quality Integration Workstreams, and developing quality project plans for GCP business deal activities.

Evaluation and Communication

• Develop and present quality-related information at relevant governance and/or operational meetings.
• Advise asset/study team on escalation pathways for quality concerns.
• Communicate key quality information (e.g., inspection/audit learnings) across asset/study and serve as asset quality expert.
• Lead asset level/study level quality risk planning activities.

Qualifications and Skills

• A minimum of 10 years of experience in quality assurance or related field.
• Advanced knowledge, experience, and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines.
• Familiarity with the relevant key therapeutic area(s).
• Strong interpersonal skills, ability to influence, engage leaders, and ability to establish and maintain excellent working relationships across lines in a matrix organization.
• Experience of working on global initiatives or project teams.
• Appreciation of diverse needs of different regulatory requirements of various sites and countries.
• Extensive knowledge of regulations in order to assess GCP situations and to coordinate resolution activities across partner lines.
• Extensive Quality-related experience, including working knowledge in areas of quality and compliance management, QC, root cause analysis, metrics development and utilization, audit and inspection conduct, and CAPA.

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