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Position Summary:
Sikich is seeking a QMS Lead to work with our Life Sciences clients to help them successfully implement and adopt our Quality Management System (QMS) software. This individual will be responsible for providing consulting services to clients throughout the implementation lifecycle, from requirements gathering, demo and scoping to user training and post-implementation support. The individual will also be responsible for providing solutions, architecture design and development to the customers & provide optimized solutions to the customer.
Experience Band: 8+ Years
Primary Job Responsibilities:
- Conduct requirements gathering, demo and scoping sessions with clients to understand their business processes and QMS requirements
- Work with the Delivery Consultants / Sr. Solution Consultant / Configuration Consultant to implement the solutions and guide the team whenever required
- Develop and execute project plans and timelines, ensuring on-time delivery and client satisfaction
- Configure the QMS software to meet client requirements and ensure data accuracy
- Provide user training and support to clients throughout the implementation process
- Work closely with the project team to ensure successful implementation, including collaborating with developers, project managers, and other consultants as needed
- Manage client relationships and communicate project status updates on a regular basis
- Travel to client sites as needed
Requirements:
- 8+ years of experience in Life Sciences Quality Management, with a focus on QMS implementation and configuration
- Experience in working with TrackWise / TrackWise Digital / Salesforce Configuration
- Configure and optimize TrackWise on Premise / TWD Solutions
- Proficiency in managing Admin Queries, SAP Crystal Reports, Webservices
- Experience in drafting Configuration Specification / Design documentation
- Experience with Installation / Upgrades
- Experience in managing the team and providing guidance to the team
- Experience in providing optimized solutions to the customer when needed
- Experience in TrackWise Schema and proficient in writing SQL Queries
- Proficient in Troubleshooting issues
- Experience in working and collaborating with multiple teams to implement the solution/project
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related fields
- Experience working with Life Sciences regulations and standards such as FDA 21 CFR Part 11, ISO 13485, and EU MDR
- Experience with software implementation projects, including requirements gathering, scoping, testing, and training
- Strong analytical and problem-solving skills, with the ability to think creatively to find solutions to complex issues
- Strong communication and interpersonal skills, with the ability to work collaboratively with clients and project team members
- Ability to travel to client sites as needed
Benefits of being a part of the team
- Family Health Insurance including parents
- Life & Accident Insurance
- Maternity/paternity leave
- Performance-based incentives
- Referral Bonus program
- Exam Fee Reimbursement Policy
- Indian festival holidays
- 5 days working week
- Doctor’s Consultation