Associate Director, Development Unit, CQA Program Lead

The Associate Director, Development Unit CQA Program Lead will provide strategic Quality oversight on the entire Clinical Trial Process (CTP) for the clinical trials under responsibility to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to patients’ safety, rights and well-being.

The successful candidate will dispense QA expertise and guidance to the Global Clinical Teams (GCT) and collaborate with other QA functions in order to ensure that high priority programs, Quality initiatives driven by the business meet defined expectations. Takes full ownership of the quality aspects of the assigned clinical trials and lead / participate in due diligence efforts for assigned programs.

Responsibilities include but are not limited to;

• Proactively provide QA leadership to the business strategy for assigned trials by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities)
• Support implementation of quality strategy within GCT under responsibility.
• Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter and ensure that all delayed activities have a documented rational and appropriate escalation.
• Ensure adequate oversight of proactive quality risk management process in the overseen areas including quality risk assessments and submission/inspection readiness activities and ensure that CTP processes are in control
• Provide robust and clear quality oversight in the following areas of clinical development :
• Proactively support / collaborate with key stakeholders (ai CPO QA, Franchises/DU’s, GPT) to ensure that risks are detected and remediated prior to allocating critical trials (as determined) to sites.
  • Establish/ lead core governance for deviation/incident management for critical or major deviations pertinent to the programs being assigned and ensure timely escalation when required
  • Provide regulatory guidance to day to day questions arising from Clinical trials deliverables
  • Collaborate with Development Operations QA to drive initiatives relevant to internal monitoring and outsourced activities Quality oversight
  • Support inspections preparation and facilitation in collaboration with other QA groups including but not limited to CPO QA, compliance and GCA.
  • Participate in audits and inspections follow-up activities including CAPA preparation
  • In collaboration with other QA functions, provide Lessons learned from deviations/incidents, audits and inspections.

• Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.
• Support continuous improvement initiatives (including Work streams) and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability
• Be QA point of contact for the defined trials and attend the meetings and ensure quality is embedded in the decision taking processes.

Desirable skills:

• 4-5 years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions.
• Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
• Ability to work independently and in a global/matrix environment.
• 3 or more years’ experience in managing projects.
• Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
• Strong skills in GCP, quality and/or clinical development.
• Strong interpersonal, communication, negotiation, and problem solving skills.

Education:

Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus.

Languages:

Fluency in English (oral and written)

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here at Novartis!

Commitment to Diversity & Inclusion:

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

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.