QBP

GlaxoSmithKline - Collegeville, PA

Full-time - Mid Level

Hybrid - Collegeville, PA

Chemical Manufacturing

About the position

The Quality Business Partner (QBP) for GLP is responsible for advocating quality within their designated area, providing strategic advice on research and development (R&D) quality, and ensuring compliance with regulatory standards. This role involves educating teams on Quality by Design and risk mitigation, while also leading initiatives to enhance quality practices across GSK and its third-party partners.

Responsibilities

• Provides matrix management and leadership to cross-functional teams.
• Serves as the Quality Business Partner for assigned GSK R&D functions, programs, and/or Third Parties.
• Collaborates with the Audit, Inspection, Risk and Issue Management team on internal quality audits and regulatory inspections.
• Leads inspection readiness activities and supports regulatory inspections.
• Supports issues identification, reporting, root cause analysis, and CAPA development.
• Evaluates and reviews standard operating procedures in support of an integrated QMS.
• Influences senior leaders to foster a commitment to quality across GSK and its partners.
• Defines, implements, and monitors the quality narrative and reports any critical risk.
• Works with R&D Data Analytics to define KPI, KQI, and metrics needs for R&D Quality and Risk Management.
• Shares key learnings to drive simplification and continuous improvement.
• Defines activities to deliver the quality strategy for the assigned function, program, and/or Third Party.
• Supports due diligence and Merger & Acquisition activities.
• Ensures rapid communication of quality issues and risks to appropriate leaders.
• Supports investigations of potential serious breaches and critical issues.
• Leads special assignments on various projects as determined by R&D Quality and Risk Management.

Requirements

• Bachelor's degree or equivalent in a scientific or quality-related field.
• 5 or more years of Pharma experience.
• Experience in drug development, regulatory compliance, or quality management.
• Experience in clinical, medical, pharmacovigilance, or regulatory quality.
• Expert knowledge of GLP and regulatory requirements.

Nice-to-haves

• Broad working knowledge of quality by design and risk management principles.
• Expert knowledge in continuous improvement tools.
• Strong quality orientation with attention to detail and adherence to standards.
• Analytical mindset for developing effective quality strategies.
• Ability to adapt to changing business needs.
• Effective communication and negotiation skills.

Benefits

• Competitive salary
• Annual bonus based on company performance
• Healthcare and wellbeing programs
• Pension plan membership
• Shares and savings program
• Hybrid working model