Associates Director, Dev Unit CQA

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Employer - Novartis
Category - Top-Senior-Management
Job title - Associates Director, Dev Unit CQA

Job Description

Provide strategic Quality oversight on the entire Clinical Trial Process (CTP) for the clinical trials under responsibility in order to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to patients’ safety, rights and well-being. Based on risk analysis, take critical decisions together with internal stakeholders, ensuring clinical trials have no delays whilst maintaining high quality level data. 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 Lead/ participate in due diligence efforts for assigned programs. Drive a culture of quality in GDD by close business collaborating to positively impact the business and implementing the Strategy, Mission and Vision of Global Development QA (GDQ).

Your responsibilities:
Your responsibilities include, but are not limited to:

1. 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.

2. 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.

3. Provide robust and clear quality oversight in the following areas of clinical development :
a. 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.
b. 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
c. Provide regulatory guidance to day to day questions arising from Clinical trials deliverables
d. Collaborate with Development Operations QA to drive initiatives relevant to internal monitoring and outsourced activities Quality oversight
e. Support inspections preparation and facilitation in collaboration with other QA groups including but not limited to CPO QA, compliance and GCA.
f. Participate in audits and inspections follow-up activities including CAPA preparation g. In collaboration with other QA functions, provide Lessons learned from deviations/incidents, audits and inspections.

4. 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.

5. Be QA point of contact for the defined trials and attend the meetings and ensure quality is embedded in the decision taking processes.

Minimum requirements What you’ll bring to the role:

Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus. Fluency in English (oral and written) ?

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Job Location Hyderabad, Telangana
Date Posted 10 Dec 2019
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