Head, Third Party Quality

GlaxoSmithKline - Collegeville, PA

Full-time - Senior

Collegeville, PA

5,001-10,000 employees

Chemical Manufacturing

About the position

The Head, Third Party Quality is a critical management role within the R&D Business Partner Quality organization at GSK. This position is responsible for the strategic oversight and development of third-party quality activities, ensuring alignment with development operations, procurement, and business units. The role involves leadership in identifying and resolving critical quality issues that may impact GSK, as well as overseeing quality governance and compliance with regulatory standards.

Responsibilities

• Develop and implement quality strategy to oversee and manage third parties' activities.
• Oversee third party quality oversight activities including qualification, quality governance and quality agreements.
• Identify areas of risks through active participation in risk-based Quality assessments for third parties.
• Collaborate with the Quality Auditing group to deliver global audits and assessments.
• Work with Quality Data Analytics to define KPI, KQI and metrics needs for R&D Quality and Risk Management.
• Ensure ongoing inspection readiness in the area of responsibility and implement required activities.
• Participate in preparation, execution and close out of health authority inspections in collaboration with Inspection Management.
• Provide quality advice and GxP expertise within the functional & process area.
• Ensure rapid communication of quality issues and risks to appropriate leaders and colleagues.
• Support investigations of potential serious breaches and critical issues.
• Share key learnings to drive simplification and replicate best practices to drive quality into the business.
• Build and maintain a Third-Party Quality team by creating an environment that attracts, develops and retains high-quality employees.
• Provide leadership, professional development, mentoring and coaching for direct and indirect reports.
• Develop, motivate, and empower direct reports to have a high degree of accountability for performance and oversight of key deliverables.
• Lead multidisciplinary or cross-functional work/project teams.
• Manage a fiscally responsible team budget including operating expenses, staffing level and outside collaborations.
• Influence the external environment through interactions with regulators, trade associations, and professional societies.
• Provide input into the global audit plan based on identified signals/trends/risks/gaps.
• Liaise with stakeholders in R&D to understand global and local needs and determine priorities.

Requirements

• Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.
• Experience in drug development, regulatory compliance or quality management.
• Experience in clinical, medical, pharmacovigilance or regulatory quality.
• Knowledge of GLP, GCP, GVP and regulatory requirements.
• Experience in TP alliance management.

Nice-to-haves

• Broad working knowledge/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.
• Ability to adapt to changing direction and needs of the business.
• Effective communication/negotiation skills and customer management skills.
• Demonstrated knowledge of Veeva QMS.
• Proven problem-solving skills to prevent and overcome complex process and quality related issues.
• Broad understanding of digitalization and decentralized clinical trial elements.
• Proven track record of building/maintaining high performance teams.
• External engagement with industry/trade/quality organisations.

Benefits

• Flexible working culture
• Professional development opportunities
• Diversity and inclusion initiatives
• Health and wellness programs