Quality Managers (Projects) - LS Domain
The ideal candidate is a critical thinker who will proactively manage & improve the quality systems of the project through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.
Roles & Responsibilities:
- Manage a Project Quality Management team through coaching, mentoring, specific training and performance evaluations.
- Balance the delivery needs of the program with the compliance needs of client
- Advocate quality & compliance and develop standardized production, quality, and customer-service standards
- Assure the quality and compliance framework is defined, approved, deployed and trained in the program teams
- Identify potential risks before they become a problem, focusing on root cause analysis and preventive action
- Oversee qualification and verification activities, including the deliverables to meet the quality and compliance requirements
- Design, implement, and report status, risk and other appropriate metrics
- Understands quality constraints / requirements of implementing a cloud platform in Pharma Industry
- Perform internal and external quality audits and compile detailed reports of findings
- Able to challenge status quo or traditional approach and propose a risk-based approach focused on both agility and quality
- Proven experience with DevOps software delivery and working in agile setup / methodologies
- Proven experience with test automation and driving operational excellence and scaling through automation.
Key requirements critical to success in this role:
- Bachelor’s Degree in Engineering.
- 10+ years of Experience in Quality Management.
Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries. Xybion specializes in the development and delivery of flexible enterprise solutions that can be easily configured, integrated or deployed out of the box to deliver the capabilities you need. Leveraging our extensive global experience working with companies of all sizes, we offer deep domain knowledge of FDA regulations and have a long track record of helping clients build effective compliance and risk mitigation strategies and solutions.