Description
Position: Sr. QA Manager, Information Technology (IT)CompliancePosition Reports To: Associate Director, Quality IT Systems and Compliance
Responsibilities:
- Must have proven experience in Part 11 compliance from a Quality prospective
- Act as QA Project Lead for all IT programs from begin to completion
- Conduct in-depth review of IT Change Control and Computerized Risk Assessment processes and documentation
- Participate and direct in the creation of computer system design and implementation documents from a Quality view point to ensure Part 11 compliance
- Author and review User Specification Requirements (URS), User Acceptance Testing (UAT), Functional Specification, IQ/OQ/PQ Protocols and Reports and Trace Matrices for accuracy, completeness and compliance to Part 11
- Author and review IT SOPs and Work Instructions for quality and compliance oversight
- Participate as an audit team member for QA audits of internal departments and vendor/suppliers providing computerized support and/or services
Experience:
- 8-10 years' experience in Quality with a focus on IT Hardware & Software Implementation
- Experience with Livelink, SmartSolve, ComplianceWire, ARISg, ComVault, SAS, VM-Ware and Sharepoint a plus
- Strong IT technical background
- Experience authoring SOP's related to IT Change Control and Quality Processes
- Strong knowledge of cGMP, GCP and ICH guidelines, Part 11 and Annex 11 for US, Canada and EU markets
Education/ Skills/ Training:
- Communication Skills:
- Ability to work with a diverse group of personalities and individuals
- Excellent writing skills
- Strong verbal communication skills
- Other Skills:
- Ability to work independently and multitasking
- Strong attention to detail and accuracy
- Ability to set schedules and meet deadlines
- Computer Skills:
- Knowledge of Software: MSWord, MSExcel, MSPowerpoint, MS Project, MSOutlook, Adobe Acrobat, and Visio desired
- B.S. or M.S. in a scientific or computer engineering discipline or equivalent experience