Description
Our client is a leading manufacturer of high-quality, affordable pharmaceuticals seeking a competent Quality Manager for an excellent contract opportunity. We are looking for someone that understands IT system life cycle and Computer System validation. Position scope will include working with cross-functional teams, providing documentation and project planning, etc. Good communication skills and willingness to go the extra mile are vital to this role.
MAJOR ACCOUNTABILITIES
- Support computer system validation, information security, IT compliance, records management and information risk management program in Wilson and multi-site Business IT Systems to ensure the integrity, confidentiality and availability of information and systems owned, controlled or processed by the organization.
- Provide compliance and computer system validation guidance and support for IT projects and IT system change controls, including evaluation that systems are implemented and operated per the client control framework.
- Support the computer system implementation manager throughout the implementation of the new IT system or changes to IT system, especially covering compliance with the corporate manual.
- Prepare/review/approve system life cycle documentation items.
- Ensure implementation of the information risk management process in the area of responsibility, including reporting and oversight of remediation/mitigation efforts to address negative findings.
- Support the client's Remediation Plan and site compliance plans related to IT systems.
- Monitor and report information risk status and issues.
- Provide oversight for IT incidents to protect assets including intellectual property, fixed assets and the company's reputation.
PROFESSIONAL EXPERIENCE
- Minimum 2 years of working experience in IT (preferably in CSV/project management/service delivery positions)
- Knowledge of general IT, project management and compliance domains
- Implementation of new processes or methodologies
- Good understanding of business processes and objectives
- Good written and verbal communication and presentation skills
- Experience with Microsoft Office Suite
- Detail oriented with appreciation for Good Documentation Practices
- Preferably strong/expert knowledge in computer system validation
- High level of customer focus with proven problem solving skills
- Group leadership experience and a good understanding and knowledge of business processes in a global health care industry
This contract position is expected to be 9 months in duration with possible extension to a year+.