Team Lead, Therapeutic Area Quality

GSK•Newbury, Massachusetts

72d•Hybrid

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. 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.

Requirements

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

Nice To Haves

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

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.
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.
Supports the preparation, execution and close out of health authority inspections.
Demonstrates implementation of quality strategy to health authorities
Participate/ provides 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.
Contributes to the review and revision of the R&D Quality and Risk Management strategy.
Leads and/or support functional initiatives as assigned.
Maintains 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