Head Compliance CQA

Job Purpose:

Are you ready to become the Head, Compliance Clinical QA? As primary quality contact for Business Process Owners (BPOs) in Development is responsible for end-to-end quality oversight of clinical processes, ensuring compliance with Health Authorities requirements and internal standards. The individual will a deep thinker and data focused.  This will mean extracting information from different data sources, summarizing in a way that is actionable and what behaviours are we wanting to drive? You will be synergizing many elements; highest risk, what the data highlights, how many and where audits take place, time constraints, fixes any risks ahead of time for Novartis in the clinical space.

Key requirements:

• Actively drive a culture of quality and successfully embed a quality mindset across Development by forging 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 the development of a robust strategy for clinical process changes, considering interdependencies and guide respective risk business owners in all aspects of risk management.

• Collaborate closely with BPOs to prepare for audits, actively participate, support formulating robust CAPA plan, ensuring its comprehensive review and flawless implementation.

• Collaborate closely with the Head GCP Inspection Management and GCP Inspection Project Manager(s) when a GCP Health Authority Inspection is announced, promptly identifying potential risk areas that may impact the process.

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

• Proactively address potential gaps and risks, while identifying valuable opportunities for continuous improvement. Drive continuous improvement through data-generated insights for the respective clinical processes, fostering a culture of excellence.

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 and/or QA position in the pharmaceutical drug development.

• Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.

• High learning agility, mentally quick, comfortable with complexity and diversity, and highly interested in continuous improvement.

• Effectively collaborating with stakeholders at all levels of the organization with a possibility to inspire and motivate cross-functional teams to drive change and promote a culture of excellence.

• Ability to present to Novartis senior management, corporate functions and to local executive team members, as well as to external audiences, health authorities and government officials.

• Proficient English language skills.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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