Head Compliance CQA

Head, Compliance Clinical Quality Assurance.

About the Role

Job Purpose:

Are you ready to become the Head, Compliance Clinical QA? As the primary quality contact for Business Process Owners (BPOs) in Development, you are responsible for end-to-end quality oversight of clinical processes, ensuring compliance with Health Authorities requirements and internal standards. You will be a deep thinker and data-focused, extracting information from various sources, summarizing it in actionable ways to drive desired behaviors. Your role involves synergizing multiple elements such as risk assessment, data analysis, audit locations, time constraints, and proactively addressing risks in the clinical space for Novartis.

Key requirements:

Actively drive a culture of quality and embed a quality mindset across Development by fostering strong business partnerships, positively impacting business deliverables, and effectively implementing the strategy, mission, and purpose of RDQ.

Guide Quality System Owners (QSOs) and BPOs in developing a robust strategy for clinical process changes, considering interdependencies, and guiding risk business owners in all aspects of risk management.

Collaborate closely with BPOs to prepare for audits, actively participate, support in formulating robust CAPA plans, ensuring comprehensive reviews, and flawless implementations.

Collaborate closely with the Head GCP Inspection Management and GCP Inspection Project Manager(s) during GCP Health Authority Inspections, promptly identifying potential risk areas.

Guide BPOs in preparing specific presentations and deliverables requested during inspections.

Proactively address gaps and risks, identify opportunities for continuous improvement, and drive excellence through data-generated insights for clinical processes.

Your Experience:

Master’s degree in life sciences/healthcare, M.D., Ph.D., or MBA is desired.

At least 10 years of involvement in regulated activities (GCP/PH), clinical development, or QA position in pharmaceutical drug development.

Broad understanding of global Health Authorities' expectations in Clinical Development and profound knowledge of product development science.

High learning agility, comfortable with complexity, and highly interested in continuous improvement.

Effective collaboration with stakeholders at all levels, ability to inspire and motivate teams, and present to diverse audiences.

Proficient in English.