Job for Senior Manager in QA & Compliance 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 : Senior Manager - QA & Compliance

Job Description :
1. Develop and maintain Quality management systems and related processes for GxP activities in Med Communications (SSP) and CSP that are aligned with Novartis Corporate Quality Manual, Policies and any other legislative requirements.
2. Provide assurance that the GxP activities within PLS SSP and CSP are in compliance with GCP, SLA’s, regulatory requirements, Novartis Corporate Quality Manual and are being conducted according to the relevant SOPs.
3. Ensure there are processes in place and in use to identify gaps/ deficiencies in the established quality management system that can independently trigger, investigate and implement the necessary corrective action in line with current external and internal standards to ensure continuous evolution of the quality system.
4. Drive the implementation of respective quality plan objectives in SSP and CSP; ensure implementation and tracking of metrics to monitor adherence to the plan.
5. Facilitate effective communications within the teams and by interacting with other QA functions and the customer QA in line with established quality agreements.
6. Conduct training sessions to increase the awareness on Quality, GxP and Data integrity aspects across the respective functions in the NGSC.
7. Provide timely and effective communication of any potential compliance gaps/risks in Med Communications (SSP) & CSP to senior PLS and NBS Quality management; lead resolution of identified gaps/ risks.
8. Ensure KQI’s are in place and reported for respective GxP activities in Med Communications (SSP) & CSP.
9. Ensure all time readiness of the service activities for internal/ customer audits (including data integrity audits), manage audit action plans and timely closure of agreed CAPAs.
10. Provide quality support and guidance in evaluating any new services in PLS and establishing necessary quality systems for the newly identified GxP service.

Candidate Profile
Degree in Life Sciences, Pharmacy or Medicine. Advanced degree desirable. Fluency in English (oral and written)
• At least 8-10 years of working experience in regulated activities, clinical development and QA; broad understanding of global expectations of Health Authorities in the area of Clinical Development
• Strong skills in GCP, quality and clinical development
• Profound understanding of the science of product development
• Ability to work independently and in a team environment
• Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors
• Strong interpersonal, communication, negotiation and problem solving skills • Strong project management skills desirable
• Considerable organization awareness (e.g. interrelationship of departments, business priori-ties), including significant experience working cross-functionally and in global teams
• Knowledge and understanding of cultural differences and diversity issues

Additional Information:
Location: Hyderabad
Education: Degree in Life Sciences, Pharmacy
Industry Type: Pharma/ Biotech/global development
Functional Area: Quality
Job ID: 231365BR