Team Lead, Therapeutic Area Quality; GCP​/Clinical Quality

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Our approach to R&D

The Team Lead, Therapeutic Area Quality (GCP / Clinical Quality) is responsible for leading a team of Quality Business Partners who provide independent GCP (Good Clinical Practice) quality oversight and expert support to key stakeholders across clinical trial conduct and R&D programs. This individual is a member of the Quality Business Partner Therapeutic Area Leadership Team and provides input into the quality strategy of this function.

This individual is responsible for ensuring that quality is designed into clinical development programs and projects across therapeutic areas and for defining quality activities that ensure submission and inspection readiness.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs of the organization, regulatory requirements, and industry best practices.
• Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis.
• Provides input into global audit plan based on identified signals/trends/risks/gaps.
• Ensure rapid communication of critical quality risks and issues, including potential misconduct, to business partner and QuRE management.
• Drive Quality by Design implementation on an asset level across clinical development activities.
• Supports the preparation, execution and close out of health authority GCP inspections (e.g., clinical investigator sites, sponsor/CRO inspections).
• Demonstrates implementation of GCP quality strategy to health authorities.
• Participate/provides expertise in Due Diligence (in-licensing activities) as applicable.
• Lead a team of QBPs that provides experienced GCP quality support for development (and life-cycle projects).
• Responsible for talent development, career development, and performance management to ensure resources are appropriately attracted, developed and deployed to deliver the quality strategy.
• Support the development of annual goals and objectives supporting the strategy.
• Contributes to the review and revision of the R&D Quality and Risk Management strategy.
• Leads and/or supports functional initiatives as assigned.
• Maintains the highest level of awareness and expertise in international GCP, GLP and GVP regulations, and internal policies and SOPs.
• May influence the external environment through interactions with regulators, trade associations or professional societies.

• Bachelor's degree or equivalent in a scientific or quality-related field, or equivalent combination of education, training and experience.
• Demonstrated expertise in Good Clinical Practice (GCP) and clinical trial quality oversight (required). This role is focused on clinical trial/GCP quality oversight, not investigational product manufacturing (GMP) quality assurance.
• Experience in pharmaceutical industry and/or clinical quality assurance.
• Demonstrated ability to work in an international environment leading a global quality team; minimum of 3 years supervisory/management experience.
• Demonstrated knowledge of principles and concepts of quality assurance, (quality) risk management, and quality by design in a clinical development context.
• Demonstrated knowledge of GLP, pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational, and planning skills.
• Broad knowledge in the areas of oncology, immunology, respiratory, vaccines.
• Experience with Veeva QMS, CTMS and related clinical quality documentation systems.

• Extensive experience in supporting regulatory authority GCP inspections.
• Broad knowledge of…