Description
GSK has bold ambitions to positively impact the health of 2.5 billion people by the end of the decade. The company's R&D focuses on discovering and delivering vaccines and medicines, combining understanding of the immune system with cutting-edge technology to transform people's lives.
The Team Lead, Therapeutic Area Quality (GCP / Clinical Quality) is responsible for leading a team of Quality Business Partners who provide independent GCP quality oversight and expert support to key stakeholders across clinical trial conduct and R&D programs. This role is a member of the Quality Business Partner Therapeutic Area Leadership Team and provides input into the quality strategy of this function.
Responsibilities:
- Continually evaluate the strategic approach, drive changes in R&D QuRE processes, and modify the quality strategy and plan to meet changing needs.
- Identify and drive continuous quality improvements based on risk assessments, audits, inspections, trends, metrics, and root cause analysis.
- Provide input into the global audit plan based on identified signals, trends, risks, and gaps.
- Ensure rapid communication of critical quality risks and issues to business partners and QuRE management.
- Drive Quality by Design implementation on an asset level across clinical development activities.
- Support preparation, execution, and close-out of health authority GCP inspections.
- Demonstrate implementation of GCP quality strategy to health authorities.
- Participate in Due Diligence activities as applicable.
- Lead a team of QBPs providing experienced GCP quality support for development projects.
- Responsible for talent development, career development, and performance management.
- Support development of annual goals and objectives.
- Contribute to review and revision of R&D Quality and Risk Management strategy.
- Lead or support functional initiatives as assigned.
- Maintain highest level of awareness and expertise in international GCP, GLP, and GVP regulations.
- May influence external environment through interactions with regulators, trade associations, or professional societies.
Requirements:
- Bachelor's degree or equivalent in a scientific or quality-related field.
- Demonstrated expertise in Good Clinical Practice (GCP) and clinical trial quality oversight.
- 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 quality assurance, risk management, and quality by design.
- Broad knowledge in areas of oncology, immunology, respiratory, vaccines.
- Experience with Veeva QMS, CTMS, and related clinical quality documentation systems.
Preferred Qualifications:
- Extensive experience in supporting regulatory authority GCP inspections.
- Broad knowledge of risk-based quality management, root cause analysis, and quality narrative/briefs concepts.
- Digital savviness, experience with AI/ML, and data analytics.
- Ability to work effectively in an international multicultural matrix organization.
- Effective communication/negotiation skills and customer management skills.
Salary: For US locations, the annual base salary for new hires in this position ranges $209,550 to $349,250.
Benefits: Available benefits include health care and other insurance benefits, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.