Head of Third Party Quality Assurance
4 weeks ago
Job Summary
The Head, Third Party Quality is a critical leadership position within the R&D Business Partner Quality organisation. This role is responsible for the development and strategic oversight of third-party quality activities, ensuring the identification and resolution of critical quality issues that may affect GSK.
Key Responsibilities
- Develops and implements quality strategies to oversee and manage third-party activities, ensuring compliance with regulatory requirements and GSK's quality standards.
- Oversees third-party quality oversight activities, including qualification, quality governance, and quality agreements, to ensure effective risk management and quality control.
- Collaborates with cross-functional teams, including Quality Auditing, Quality Data Analytics, and Inspection Management, to deliver global audits and assessments, and to ensure ongoing inspection readiness.
- Provides quality advice and GxP expertise to stakeholders, ensuring rapid communication of quality issues and risks, including potential misconduct, to appropriate leaders and colleagues.
- Supports the investigations of potential serious breaches and critical issues, and shares key learnings to drive simplification and replicate best practices to drive quality into the business.
Talent Development/Management
- Builds and maintains a high-performing Third-Party Quality team by creating an environment that attracts, develops, and retains high-quality employees.
- Provides leadership, professional development, mentoring, and coaching for direct and indirect reports, including talent planning and performance management.
Requirements
- Bachelor's degree or equivalent in a scientific or quality-related field, or equivalent combination of education, training, and experience.
- Experience in drug development, regulatory compliance, or quality management, with a strong understanding of GLP, GCP, GVP, and regulatory requirements.
- Knowledge of Veeva QMS and experience in TP alliance management.
Preferred Qualifications
- Broad working knowledge and expertise in principles and concepts of quality by design, risk management, and quality positions.
- Solid working knowledge in continuous improvement, with a background in the appropriate tools.
- Strong quality orientation, including the ability to focus on details and adherence to standards while maintaining a business perspective.
- Analytical mindset to develop effective quality strategies for dealing with current and future industry trends.
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