Senior Director Quality Business Partner: Research & Precision Medicine

Site Name: UK - Hertfordshire - Stevenage, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Nov 8 2024 Are you energized by the opportunity to develop and deliver quality strategies for Research and Precision Medicine?
If so, the Senior Director, Quality Business Partner: Research & Precision Medicine role could be an exciting opportunity to explore.
The Senior Director, Quality Business Partner: Research and Precision Medicine is responsible for developing and delivering the quality strategy for the portfolio within the scope of Research and Precision Medicine.
The incumbent manages a small team of Quality Business Partners and will provide assurance to GSK R&D senior management that GSK research and precision medicine processes are effective in ensuring the integrity of the data, compliance with internal GSK requirements and applicable external regulatory requirements and industry best practices.
The position will develop methods to effectively and efficiently provide proactive quality support and consultation and drives quality into the business.
The Senior Director, Quality Business Partner: Research and Precision Medicine is a member of the Function & Process Quality Leadership team and with other members of the LT, responsible for the strategy and direction of this function.
Application closing date: 22nd November 2024 Responsibilities include This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include some of the following: Functional Expertise: Has direct accountability for the quality strategy for Research and Precision Medicine Considered a strong trusted partner for Research and PMed leaders Build and lead a Quality team that provides experienced quality support for research and precision medicine assets and projects.
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 the global audit plan based on identified signals/trends/risks/gaps Provide guidance and expectation to the business to build in quality by design and to enable the execution of external regulations and internal standards Interact with executive management and cross-functional business partner to identify areas of greatest quality risks and obtain information and feedback relevant to improvement.
Drives issue resolution.
Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partner and executive management.
Supports the preparation, execution and close out of health authority inspections Participates in Due Diligence and Merger & Acquisition activities in early phase of development or related to CDx/IVD Provides training to QuRE and Business Partners regarding Good Research/Science Practices, GLP, clinical testing, IVD/CDx, and Medical Devices Leadership/People Management: Established network of peers in Big Pharma, to enable constant benchmarking Build and maintain a Research and Precision Medicine Quality team by creating an environment that attracts, develops and retain high-quality employees Provides leadership, professional development, mentoring and coaching for direct and indirect reports, including talent planning and performance management Develop, motivate, and empower direct reports to have ahigh degree of accountability for performance and the oversight of key deliverables Other: Leads multidisciplinary or cross-functional work/project teams Provides 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 Liaise with stakeholders in R&D to understand global and local needs and determine priorities Why you?
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 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 GCP/GVP/GLP Audit program management Must have operated in a senior management role with extensive supervisory/management experience Knowledge of GLP, GCP, Medical Device and IVD requirements, as well as analytical, organisational and planning skills Knowledge of risk management and quality narratives Budget and resourcing management experience Experience leading global multidisciplinary, functional, line and matrix teams.
Experience managing key stakeholders Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in supporting regulatory authority inspections Broad knowledge of Risk-based quality management, root cause analysis and quality by design 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 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 organisation where people can thrive.
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