Team Lead, Therapeutic Area Quality

The Team Lead, Therapeutic Area Quality is responsible for leading a team of Quality Business Partners that deliver independent quality expert support to key stakeholders. This role contributes to the quality strategy of the function and ensures that quality is designed into programs and projects across therapeutic areas.

Responsibilities

• Continually evaluate the strategic approach, drive changes in R&D QuRE processes, and modify the quality strategy and plan to meet changing regulatory and industry best practices.
• Identify and drive continuous quality improvements through risk assessments, audits, inspections, trend/metric analysis, 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, including potential misconduct, to business partners and QuRE management.
• Drive Quality by Design implementation at the asset level.
• Support preparation, execution, and close-out of health authority inspections.
• Demonstrate the implementation of the quality strategy to health authorities.
• Participate in or provide expertise for due diligence (in-licensing) activities as applicable.
• Lead a team of QBP that provides quality support for development and life-cycle projects.
• Responsible for talent development, career development, and performance management of the team.
• Support development of annual goals and objectives aligned with strategy.
• Contribute to the review and revision of the R&D Quality and Risk Management strategy.
• Lead and/or support functional initiatives as assigned.
• Maintain a high level of awareness and expertise in international GLP, GCP, and GVP regulations, as well as internal policies and SOPs.
• May influence the external environment through interactions with regulators, trade associations, or professional societies.

Qualifications

• Bachelor's degree or equivalent in a scientific or quality-related field or an equivalent combination of education, training, and experience.
• Experience in the pharmaceutical industry and/or quality assurance.
• Demonstrated ability to work in an international environment leading a global quality team; minimum of 3 years supervisory/management experience.
• Knowledge of quality assurance principles and concepts, risk management, and quality by design.
• Knowledge of GLP, GCP, pharmacovigilance/drug safety, regulatory requirements, and strong analytical, organizational, and planning skills.
• Broad knowledge in oncology, immunology, respiratory, and vaccine areas.

Preferred Qualifications

• Extensive experience supporting regulatory authority inspections.
• Broad knowledge of risk-based quality management, root-cause analysis, and quality narrative/brief concepts and methodology.
• Digital savviness, experience with AI/ML and data analytics.
• Ability to work effectively in an international multicultural matrix organization.
• Effective communication, negotiation, and customer-management skills.
• Experience with Veeva QMS, CTMS, and DocuSign.

Compensation & Benefits

• Salary range: $209,550–$349,250 in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA. $190,500–$317,500 in other U.S. locations.
• Annual bonus and eligibility to participate in a share-based long-term incentive program.
• Benefits include health care and other insurance (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
• Additional compensation details will be discussed during the recruitment process.

EEO Statement

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service, or any basis prohibited under federal, state or local law.