Job Description

Job Purpose

The position is responsible for leading a team of Quality Business Partner that deliver independent quality expert support to stakeholder. The incumbent is a member of the QBP Therapeutic Area LT and provides input into the quality strategy of this function. The position 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.  

Key Responsibilities

Functional Expertise: 

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. 

Leadership/People Management 

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. 

Other 

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 

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; with previous supervisory/management experience. 

Knowledge of principles and concepts of quality assurance, (quality) risk management, and quality by design 

Knowledge of GLP, GCP, pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organisational, and planning skills  

Knowledge in the areas of oncology, immunology, respiratory, vaccine  

Preferred Qualifications

Experience in supporting regulatory authority inspections. 

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