Senior Director Quality Business Partner: Clinical Development

Do you have a passion for developing and delivering a quality strategy for clinical development? If so, the Senior Director Quality Business Partner: Clinical Development role could be an exciting opportunity to explore.

The Senior Director Quality Business Partner: Clinical Development is responsible for developing and delivering the quality strategy for the portfolio within the scope of Clinical Development.

The position will develop methods to effectively and efficiently provide proactive quality support and consultation and drives quality into the business.

The incumbent manages a small team of Quality Business Partners and will provide assurance to GSK R&D senior management that GSK development processes are effective in ensuring the integrity of the data, compliance with external regulatory requirements and internal GSK requirements, and protection of patients.

The Senior Director, QBP Clinical Development is a member of the Functional Process Quality Leadership team and with other members of the LT, responsible for the strategy and direction of this function.

Responsibilities include

• Has direct accountability for the quality strategy for Asia Development, Clinical Operations and the Addenbrookes Clinical Pharmacology Unit (CUC).
• Build and lead a Quality team that provides experienced quality support for Asia Development, Clinical Operations and Process related projects and initiatives.
• 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.
• Provide guidance and expectation to the business to build in quality by design and to enable the execution of external regulations and internal standards.
• Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partner and executive management.

Risk Assessment and Audit Strategy

• Oversee risk assessments for the audit universe within area of responsibility, ensuring that high-risk areas are identified and prioritized for audits or other quality interventions.
• Provide input into the global audit plan based on identified signals/trends/risks/gaps.

Inspection Readiness

• Foster a culture of inspection readiness by developing proactive quality strategies, leading inspection readiness initiatives, and supporting successful regulatory inspections.

Leadership/People Management

• Build and maintain a Clinical Development Quality team by creating an environment that attracts, develops and retains high-quality employees.

Knowledge Sharing and Quality Culture

• Promote a strong quality culture across the Development organization, emphasizing the importance of quality in achieving quality and business objectives.
• Champion the continuous improvement of quality systems and processes, fostering a culture of accountability, innovation and excellence.

Cross-functional collaboration

• Collaborate closely with Clinical Operations, Asia Development, OCMO and other functions to ensure quality is integrated into clinical development strategies and operations.
• Serve as a trusted partner to senior leadership, providing expert guidance on quality risks, challenges, and opportunities related to clinical development.

Other

• Lead multidisciplinary or cross-functional work/project teams.
• Provide guidance and expectations to the business to enable execution of external regulations and internal standards on a global and cross-functional level.
• May influence the external environment through interactions with regulators, trade associations, and professional societies.
• Represent the QuRE function in Development governance forums, Global Written Standards Steering Committees/Community of Practice.

Why you?

Basic Qualifications:

• Bachelor’s degree or equivalent in scientific, engineering or quality-related field.
• Experience in the pharmaceutical industry and/or quality assurance, quality management or risk management.
• Leadership of one or more GCP/GVP/GLP Audit program management.
• Must have operated in a senior management role with supervisory/management experience.
• Experience leading global multidisciplinary, functional, line and matrix teams.
• Knowledge of drug development process, global and national regulatory requirements, especially ICH-GCP as well as analytical, organizational and planning skills.
• Knowledge of risk management and quality narratives.
• Leadership skills with demonstrated success in managing and developing high-performing teams.
• Experience managing key stakeholders.

Preferred Qualifications:

• Experience in supporting regulatory authority inspections.
• Broad knowledge of Risk-based quality management, root cause analysis and quality by design concepts and methodology.
• Broad knowledge of Asia drug development requirements, especially China and Japan.
• 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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their well-being. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we are open to all talent.