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 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:

• Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs to the organization, regulatory requirements, and industry best practices.
• Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis.
• Provide input into global audit plan based on identified signals/trends/risks/gaps.
• Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partner 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/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).
• Responsible for talent development, career development, and performance management to ensure resources are appropriately attracted, developed and deployed to deliver the quality strategy.
• Support the development of annual goals and objectives supporting 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 the highest level of awareness, expertise in international GLP, GCP and GVP regulations, and internal policies and SOPs.
• May influence the external environment through interactions with regulators, trade associations or professional societies.

Basic Qualifications:

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

Preferred Qualifications:

• Extensive experience in supporting regulatory authority inspections.
• Broad knowledge of Risk-based quality management, root cause analysis and quality narrative/briefs 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 skills and customer management skills.
• Experience with Veeva QMS, CTMS and Doc.

Salary & Benefits:

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $209,550 to $349,250. If you are based in another US location, the annual base salary range is $190,500 to $317,500.

In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD0 to CAD0, determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.

Benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. 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.