Team Lead, Therapeutic Area Quality

Position Summary

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 individual is a member of the Quality Business Partner Therapeutic Area Leadership Team and provides input into the quality strategy of this function. This individual is responsible for ensuring that quality is designed into programs and projects across therapeutic areas and for defining quality activities that ensure submission and inspection readiness.

Job Responsibilities

• Continuously evaluate the strategic approach, drive changes in R&D QuRE processes, and modify the quality strategy and plan to meet changing organizational, regulatory, and industry needs.
• Identify and drive continuous quality improvements resulting from 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, including potential misconduct, to business partners and QuRE management.
• Drive Quality by Design implementation on an asset level.
• Support the preparation, execution, and close out of health authority inspections.
• Demonstrate implementation of quality strategy to health authorities.
• Participate in or provide expertise in due diligence (in-licensing activities) as applicable.
• Lead a team of QBP that provides experienced quality support for development and life-cycle projects.
• Oversee talent development, career development, and performance management to ensure resources are appropriately attracted, developed, and deployed.
• Support the development of annual goals and objectives aligned with the 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 expertise in international GLP, GCP, and GVP regulations, internal policies, and SOPs.
• Influence the external environment through interactions with regulators, trade associations, or professional societies.

Basic 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.
• Demonstrated knowledge of quality assurance principles and concepts, risk management, and quality by design.
• Demonstrated knowledge of GLP, GCP, pharmacovigilance/drug safety, and regulatory requirements, along with analytical, organizational, and planning skills.
• Broad knowledge of 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/briefing concepts and methodology.
• Digital savviness, experience with AI/ML and data analytics.
• Ability to work effectively in an international multicultural matrix organization.
• Excellent communication, negotiation, and customer-management skills.
• Experience with Veeva QMS, CTMS, and Doc.

Salary and Benefits

• If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary ranges from $209,550 to $349,250.
• If based in another U.S. location, the annual base salary range is $190,500 to $317,500.
• Position offers an annual bonus and eligibility to participate in a share-based long-term incentive program.
• Benefits include health care and other insurance coverage for employees and families, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
• Salary ranges may be discussed during the recruitment process for locations without posted ranges.
• For Canadian locations, salary ranges are determined based on experience, qualifications, and internal equity.

Equal Opportunity 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 (including family medical history), military service or any basis prohibited under federal, state or local law.