Team Lead, Therapeutic Area Quality (GCP / Clinical Quality)

The Team Lead, Therapeutic Area Quality (GCP / Clinical Quality) is responsible for leading a team of Quality Business Partners who provide independent GCP (Good Clinical Practice) quality oversight and expert support to key stakeholders across clinical trial conduct and R&D programs. 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 clinical development programs and projects across therapeutic areas and for defining quality activities that ensure submission and inspection readiness.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• →Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs of 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.

• →Provides 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 across clinical development activities.

• →Supports the preparation, execution and close out of health authority GCP inspections (e.g., clinical investigator sites, sponsor/CRO inspections).

• →Demonstrates implementation of GCP quality strategy to health authorities.

• →Participate/provides expertise in Due Diligence (in-licensing activities) as applicable.

• →Lead a team of QBPs that provides experienced GCP 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.

• →Contributes to the review and revision of the R&D Quality and Risk Management strategy.

• →Leads and/or supports functional initiatives as assigned.

• →Maintains the highest level of awareness and expertise in international GCP, GLP and GVP regulations, and internal policies and SOPs.

• →May influence the external environment through interactions with regulators, trade associations or professional societies.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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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.

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