Senior Consultant - Global Healthcare Sector

India's marquee global technology & consulting company. They are an international flag-bearer of technical and managerial excellence, currently experiencing a significant growth surge. With offices around the globe, the company has a comprehensive presence across multiple segments of the technology product and service industries as well as a blue-chip roster of clients for their Consulting engagements. They are a respected career company and a long-term wealth creator.

The Job :

- Complex consulting assignments in the global Pharma and Healthcare industry across Regulatory Affairs, Process Implementation and Transformation.

- This is a client-facing role in which you will have end-to end responsibility for management and delivery of distributed assignments. The role will be hands-on and could include responsibility to manage teams.

Your Profile

You must be an MBA from a premier business school, preferably with an Engineering or Life Sciences degree and 4-10 years of post qualification experience in the global Pharma or Healthcare sector. Experience must include complex consulting and problem-solving assignments. You must have hands-on experience in delivering in one of the following areas in a client-facing role either as an individual contributor, or managing a team:

- Audit & Risk Management, Third party risk management, Control Maturity Assessment; Framework understanding of process, methodology, tools, templates & best practices; Audit of pharma process SOPs including technology processes to ensure compliance

- Pharma and Medical Device compliance regulations-CSV, 21 CFR Part 11, GxP, GAMP 5, SOX IT; Working on - RPA, Cloud Validation, etc. Understanding of Agile and Devops Methodology

- Pharma regulatory Consulting with experience in working on IT projects including documenting URS, FS, Traceability matrix, testing, supporting UAT, working on IDMP/XEVMP and SPOR Implementation, preferably with experience in utilization of submission management or document management tools;