Description
Position: QA Manager, Quality Business System AdministrationPosition Reports To: Associate Director, QA IT Systems and Compliance
Essential Duties and Responsibilities:
- Maintain system administrative and day-to-day support functions for Quality Enterprise IT systems such as LiveLink EDMS, Pilgrim QMS and ComplianceWire LMS
- Interface with vendors and IT to address and resolve system issues and appropriately communicates gating items to management, Business Process Owners and users
- Lead the development and validation of software implementation projects involving existing or new systems to improve the overall accuracy, efficiency, and effectiveness of the business processes
- Drive the analysis, development, testing, validation and deployment of configuration, workflow, reporting and/or software updates
- Assist in end user training on Quality Enterprise IT systems as needed
- Participates in the continuous improvement and development of Quality Systems to ensure quality and adherence to cGMPs; Supports the development and management of quality metrics to optimize performance, productivity, effective resource planning, and management review
Experience:
- Minimum 7 years of experience in Quality Assurance
- Minimum 3 years of Business System Administration of Quality Enterprise IT software systems
- Minimum of 7 years in the pharmaceutical, biotech, diagnostics, medical device or healthcare industry
- Knowledge of cGMP and ICH guidelines
Skills/ Training/Education:
- Required Technical Skills:
- Demonstrated knowledge and experience with the administration of Quality Enterprise IT software systems
- Working knowledge of relational database management systems such as Oracle and MSSQL
- Strong knowledge of applicable Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH)
- Strong knowledge of 21 CFR Part 11 and Annex 11 Regulations
- Experience in implementing and maintaining GXP computer systems in a validated state with the ability to assess compliance risks
- Education Requirements:
- 9+ years of relevant experience in a GMP environment related field and a BS or BA
- 7+ years of relevant experience and a MS
- Degree in Life Sciences or Computer related fields are required