Life Sciences Management Consultant - (GRC)

Educational Requirements

• Bachelor of Engineering
• Bachelor of Pharmacy
• Bachelor of Science
• Master of Business Administration
• Master of Pharmacy
• Master of Science

Service Line Responsibilities

• Be responsible for the delivery of business results to global health and life sciences clients.
• Serve as a team member, track lead or engagement lead on business consulting engagements for clients.
• Execute consulting engagements in a global delivery model, working with consultants across regions.
• Analyze problems, and structure complex business analyses.
• Work with cross functional client teams to perform gap analysis and identify improvement options.
• Effectively collaborate with the internal and external stakeholders.
• Participate in a variety of firm building events.

Additional Responsibilities

• Knowledge of validation tools and templates used in the pharmaceutical industry.
• Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.
• Preferable IT background to understand complexities on the program.
• Experience in Agile and waterfall methodology.
• Knowledge and hands on experience in conducting periodic or control maturity assessment and Audits.
• Knowledge in SaaS/Cloud.

Technical and Professional Requirements

• 4-14 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.
• Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
• Experience creating, reviewing and approving / acknowledging validation deliverables.
• Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements.
• Experience in validation of Enterprise applications such as SAP / S4 HANA projects, Trackwise, QMS, DMS and etc.
• Functional knowledge in any of the domain applications such as Clinical applications like EDC, CTMS etc., Regulatory applications like CDR, or any other applications/system used in Pharma industry.
• Thorough knowledge in compliance and validation concepts. (Change, Deviation, Supplier management).

Preferred Skills

• Domain: Healthcare: Regulatory Compliance & Standards
• Domain: LifeSciences: LifeSciences - ALL
• Technology: Life Sciences: Regulatory Systems
• Technology: Risk Management: Risk Management System
• Domain: LifeSciences: Pharma Regulations