Director, Senior Clinical Quality Management Lead (all genders)

Your Role:

The Clinical Quality Management (CQM) Lead is responsible for leading the implementation of risk-based quality management for the clinical trials that you’re assigned to support. These responsibilities include, but are not limited to, leading the identification of critical to quality factors, leading quality risk identification, prioritization, and management, leading the specification and oversight of pre-defined acceptable ranges (e.g. QTLs), leading quality issue management and continuous improvement, and leading inspection readiness and preparation. As a core member of the clinical study team, the CQM Lead provides guidance on GCP quality principles and performs consistent oversight to ensure adherence to key quality and compliance standards. The CQM Lead is the key quality management interface with trial teams, including with relevant service providers and other internal quality functions.

Quality by Design (QbD)/Quality Risk Management

• You lead study teams to identify factors (processes and data) that are critical to quality and to proactively identify, prioritize, and manage important risks to quality.
• Furthermore, you ensure that operational feasibility and interested party insights are integrated into the clinical study protocol and associated quality risk management plans.
• You will also lead teams to pre-define acceptable ranges (e.g. QTLs) for critical to quality risks, setting appropriate thresholds, and consistently overseeing and managing performance.

Risk-Based Monitoring

• Support study teams to ensure critical to quality factors and associated risks are in focus as study teams develop the associated risk-based monitoring plans.
• Partner to ensure that selected KRIs focus on at-risk areas and complement other study-level quality performance measures.

Quality Issue Management

• Lead study teams to thoroughly investigate, assess the impact and root cause(s) of, and to correct/prevent quality issues.

Inspection Readiness and Preparation

• Lead study teams to ensure that inspection readiness is maintained at all times, and that fit-for-purpose storyboards are proactively prepared to address key issues, events, and decisions.
• You also partner with R&D Quality to co-lead inspection preparation activities, as appropriate.

Who you are:

Minimum Qualifications:

• Master\’s degree in Medical or Life Science (or equivalent industry experience) required, PhD preferred.
• Expert knowledge of Good Clinical Practice.
• Minimum of 12 years experience in leading processes related to clinical trial design, planning, start-up, conduct, oversight, analysis, and reporting.

Preferred Qualifications:

• Strong understanding of Quality by Design principles, clinical quality risk management processes, risk-based monitoring, and trial oversight – as required by ICH E6 R2.
• Ability to lead GCP inspection readiness and preparation activities and support global health authority inspections.
• Acts as GCP/risk-based quality management Subject Matter Expert for clinical study teams.
• Strong data insights and analytical skills to identify trends and drive quality/process improvements.
• Ability to make risk-based decisions based on a robust benefit/risk assessment. Uses appropriate interpersonal skills to influence people (without authority).
• Strong knowledge management, project management and change management skills.
• Ability to work proactively and independently on assigned tasks or projects of increasing complexity and/or sensitivity.
• Proficient in verbal and written English.

This position can be filled in Germany, Switzerland, France, UK and the US.

Department: HC-RD-DQ Clinical Quality Management
Job evaluation: AT-level 4 (Project Manager)

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