The Associate Director, Clinical QA will provide Quality oversight for the end-to-end clinical process 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.

About the Role

Key Responsibilities:

Proactively provide QA leadership to the business strategy for assigned programs/trials by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities).
Drive implementation of quality strategy within GCT/CTT under responsibility.
Regularly monitor the implementation of the annual Quality Plan pertaining to the assigned programs/studies.
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:
- Support/collaborate with key stakeholders (e.g., CDQ, DUs, GCT and/or CTT members) to ensure that risks are detected and remediated.
- Support core governance for quality incident management for critical and major deviations pertinent to the programs being assigned and ensure timely escalation when required.
- Provide GCP guidance to day-to-day questions arising from Clinical trials deliverables.
- Collaborate with Country Development QA and ESP QA to drive initiatives relevant to internal monitoring and outsourced activities Quality oversight.
- Support inspections preparation and facilitation in collaboration with other QA groups within RDQ.
- Support audits and inspections follow-up activities including CAPA preparation.
Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.
Active participation in 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 making processes.

Minimum Requirements:

Bachelor's degree in life science or healthcare field required. Advanced degree or equivalent education/degree in life sciences/healthcare preferred (PhD/MD/PharmD/Masters).
7 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.
Prior experience in RLT strongly preferred.
Ability to work independently and in a global/matrix environment.
3 or more years' experience in managing projects.
Strong skills in GCP, quality and/or clinical development.

The pay range for this position at commencement of employment is expected to be between $158,400 and $237,600 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

The ideal location for this role is East Hanover, NJ, where hybrid working principles apply. A distant working arrangement may be considered in certain states for US associates who are not within a daily commutable distance (more than 50 miles one way). This position will require 10% travel as defined by the business (domestic and or international).

Commitment to Diversity and Inclusion:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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Associate Director, Clinical QA