Team Lead, Therapeutic Area Quality
GSK
July 03, 2026
Remote friendly (Boston, MA)
United States
Operations
Position Summary:
- The Team Lead, Therapeutic Area Quality leads a team of Quality Business Partners providing independent quality expert support to key stakeholders. Serves on the Quality Business Partner Therapeutic Area Leadership Team, contributes to quality strategy, ensures quality is designed into programs/projects across therapeutic areas, and defines quality activities to support submission and inspection readiness.
Job Responsibilities:
- Continually evaluate and adjust R&D QuRE processes, quality strategy and plan to meet changing organizational needs, regulatory requirements, and industry best practices.
- Drive continuous quality improvements from risk assessments, audits, inspections, trends/metrics, and root cause analysis.
- Provide input into the global audit plan based on signals/trends/risks/gaps.
- Ensure rapid communication of critical quality risks/issues, including potential misconduct, to business partners and QuRE management.
- Drive Quality by Design implementation at an asset level.
- Support preparation, execution, and close-out of health authority inspections; demonstrate quality strategy implementation to health authorities.
- Participate/provide expertise in due diligence for in-licensing as applicable.
- Lead QBP team supporting development and life-cycle projects; oversee talent/career development and performance management.
- Support development of annual goals/objectives; contribute to review/revision of R&D Quality and Risk Management strategy; lead/support assigned functional initiatives.
- Maintain expertise in international GLP, GCP, GVP regulations and internal policies/SOPs; may influence externally via regulators and professional societies.
Basic Qualifications:
- Bachelor’s degree (or equivalent) in scientific or quality-related field, or equivalent education/training/experience.
- Pharmaceutical industry and/or quality assurance experience.
- International experience leading a global quality team; minimum 3 years supervisory/management experience.
- Knowledge of quality assurance, quality risk management, and quality by design.
- Knowledge of GLP, GCP, pharmacovigilance/drug safety, regulatory requirements; analytical/organizational/planning skills.
- Broad knowledge in oncology, immunology, respiratory, and vaccines.
Preferred Qualifications:
- Extensive experience supporting regulatory authority inspections.
- Risk-based quality management, root cause analysis, quality narrative/briefs.
- Digital savvy (AI/ML, data analytics).
- Experience in international multicultural matrix organizations.
- Communication/negotiation and customer management skills.
- Experience with Veeva QMS, CTMS, and Doc.
- The Team Lead, Therapeutic Area Quality leads a team of Quality Business Partners providing independent quality expert support to key stakeholders. Serves on the Quality Business Partner Therapeutic Area Leadership Team, contributes to quality strategy, ensures quality is designed into programs/projects across therapeutic areas, and defines quality activities to support submission and inspection readiness.
Job Responsibilities:
- Continually evaluate and adjust R&D QuRE processes, quality strategy and plan to meet changing organizational needs, regulatory requirements, and industry best practices.
- Drive continuous quality improvements from risk assessments, audits, inspections, trends/metrics, and root cause analysis.
- Provide input into the global audit plan based on signals/trends/risks/gaps.
- Ensure rapid communication of critical quality risks/issues, including potential misconduct, to business partners and QuRE management.
- Drive Quality by Design implementation at an asset level.
- Support preparation, execution, and close-out of health authority inspections; demonstrate quality strategy implementation to health authorities.
- Participate/provide expertise in due diligence for in-licensing as applicable.
- Lead QBP team supporting development and life-cycle projects; oversee talent/career development and performance management.
- Support development of annual goals/objectives; contribute to review/revision of R&D Quality and Risk Management strategy; lead/support assigned functional initiatives.
- Maintain expertise in international GLP, GCP, GVP regulations and internal policies/SOPs; may influence externally via regulators and professional societies.
Basic Qualifications:
- Bachelor’s degree (or equivalent) in scientific or quality-related field, or equivalent education/training/experience.
- Pharmaceutical industry and/or quality assurance experience.
- International experience leading a global quality team; minimum 3 years supervisory/management experience.
- Knowledge of quality assurance, quality risk management, and quality by design.
- Knowledge of GLP, GCP, pharmacovigilance/drug safety, regulatory requirements; analytical/organizational/planning skills.
- Broad knowledge in oncology, immunology, respiratory, and vaccines.
Preferred Qualifications:
- Extensive experience supporting regulatory authority inspections.
- Risk-based quality management, root cause analysis, quality narrative/briefs.
- Digital savvy (AI/ML, data analytics).
- Experience in international multicultural matrix organizations.
- Communication/negotiation and customer management skills.
- Experience with Veeva QMS, CTMS, and Doc.