[Medical Affairs] Clinical and Medical QA

[KEY ACCOUNTABILITIES AND RESPONSIBILITIES]
1. Proactively provide strong QA support to the business strategy for medical department  by ensuring considerable organization awareness (e.g. interrelationship of departments and business priorities)
2. Support implementation of the quality strategy within clinical operations team under responsibility.
3. Regularly create and monitor the implementation of the annual Quality Plan and ensure that all delayed activities have a documented rational and appropriate escalation.
4. Provide robust and clear quality oversight in the following areas of clinical development :
  - Proactively support / collaborate with key stakeholders to ensure that risks are detected and remediated. 
  - Support core governance for deviation/incident management for critical or major deviations pertinent to the studies being assigned. 
  - Provide GCP guidance to day to day questions arising from clinical studies and NIS deliverables, as well as participate in review and approval of critical clinical study documents (e.g., Protocols), as appropriate.
  -  Collaborate with R&D QA to support initiatives relevant to internal monitoring and outsourced activities 
  - Quality oversight of internal and outsourced clinical development activities and collaboration with involved business partners.
  - Support inspection management (preparation, hosting, follow-up) in collaboration with other QA groups including but not limited to GQA, legal & compliance, as assigned.
  - Support audit planning, management and follow-up; lead and participate in audits, as assigned.
5. In collaboration with other QA functions, provide Lessons learned from deviations/incidents, audits and inspections
6. Support continuous improvement initiatives (including quality in medical advisory group of medical de-partment ) and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability. Support SOP writing and review as assigned, as well as support GCP training as assigned.
7. Represent the main CQA point of contact for defined study teams and attend the key governance meetings and ensure that quality discussions are part of the key agenda topics on a monthly and quarterly basis.