Regulatory Inspection Quality Manager Require at Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Regulatory Inspection Quality Manager

Job Description:
1. Assist in the coordination of planning and support management for assigned inspections
2. Collaborate with the Regulatory Inspection Quality Lead and the Head of Regulatory Risk and Compliance to ensure a risk based approach for the management of submissions and inspections
3. Liaise with functional quality groups on logistics and operations to ensure a smooth inspection process
4. Provide backroom inspection support as needed in Hyderabad and Mumbai offices or globally as required.
5. Track HA Inspection CAPA commitments in AQWA to ensure timelines are achieved supporting the Inspection Governance Board as needed
6. Support the collation of inspection findings to ensure escalation and mitigation of emerging trends
7. Assists the Regulatory Inspection Quality Lead on enhancements to process management and controlled quality documents (i.e. SOPs, WPs, workflows) related to HA inspections
8. Follow up on receipt of inspection reports from HA
9. Support gathering of information from inspections, audits, regulatory intelligence, KPI/KQI, and other quality activities and initiatives, and ensure successful translation into key needs and improvement opportunities for GDQ
10. Where appropriate, perform effectiveness checks in order to monitor and document that re-occurrence of issues after implementation of improvements is successfully avoided
11. Contribute to the GCP HA Inspection Library Team in the development and maintenance of inspection tools, documents, and training materials
12. Provide assistance for Local and Global Inspections targeting Hyderabad site
13. Support critical quality improvement projects

Candidate Profile:
Degree in Life Sciences, Pharmacy or Medicines Fluency in English (oral and written), additional languages a plus. Preferably an Asian language e.g. Chinese
• Minimum of 5 years in the pharmaceutical industry, preferably in quality, clinical development, and/or with a Health Authority
• Strong organizational awareness (e.g. inter-relationships of departments, business priorities)
• Broad understanding of relevant GxP regulations and global expectations of Health Authorities in the area of Pharma Development.
• Strong people interaction skills, with ability to successfully lead and engage culturally diverse project teams.
• Robust knowledge of Novartis Quality, Drug Development, and respective governance
• Ability to work globally to initiate and co-ordinate the work of associates at all levels

Additional Information:
Experience: 5 years
Location: Hyderabad
Education: Degree in Life Sciences, Pharmacy
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality
Division: Pharma
Job Type: Full Time
Job ID: 226308BR
End Date: 31^st November, 2011