Join bluebird bio’s enthusiastic and collaborative team to contribute to the overall success of our novel gene therapy approach. We seek an experienced IT professional to join our North Carolina manufacturing facility.
We are seeking a highly motivated Manager, Computer System Validation with strong skills in CSV, IT, and Quality. Working with the corporate Computer System Validation Manager, this individual will work on CSV system implementation projects, change controls, and will assist in the development and execution of the CSV program at bbb, and assist in developing the vision, mission, and strategic objectives for this cross-functional function partnering with Quality Assurance Validation, IT, and business system owners across the organization. This position is responsible for assuring that bluebird bio’s GxP computerized systems are compliant with EU, and ICH guidelines and U.S. GMP regulations.
About the position:
- Act as IT CSV approver for project-related CSV documents on cross-functional teams that include Business Owners, IT System Administrators and System Owners, and Quality Assurance on projects including enterprise SaaS software, GMP Manufacturing systems (Process Automation, Environmental Monitoring), laboratory systems, quality documentation and management systems, electronic learning management, and supply chain systems (ERP, SCM).
- Partnering with the corporate manager of computer systems validation in the development of GMP systems specific SDLC policies & procedures including risk-analysis, validation, operational change management, periodic review, etc…
- Experience with automation and/or process control systems & QC laboratory systems is a requirement.
- Ensure that GxP computer systems are designed, validated, and operated in compliance with internal bluebird procedures and external regulatory requirements.
- Proactively maintain IT compliance across bluebird bio’s GxP IT Portfolio, identifying risks and proactive initiatives, when applicable
- Participate in the review of completed software quality audit questionnaires for software development methodology, testing standards, configuration management, patches, and security assessments
- Partner with IT Compliance and Quality to monitor observations and issues identified during audits. Report progress, and justify or remediate the issues identified, initiating CAPA, performing gap analysis, and implementing process improvements where required.
- Provide technical leadership and support to the bluebird bio IT organization by; assessing and make recommendations on computer-related systems, databases and tools to be used in execution of GMP computerized systems.
- Provide technical support as the Computer Systems Compliance SME during the development of system documentation such as user requirements, procedures, training modules, etc.
- Function as IT technical lead for evaluation of validation/qualification approach.
- Remain current in regulatory and industry trends. Educate, instruct and/or train colleagues on the same.
- Develop and maintain GMP computer system inventory list.
- Participate in functional risk assessment for computer systems.
- Be willing to mentor and provide direction on CSV to members of project implementation teams, as needed.
- Preferred: experience with Veeva QualityDocs, Veeva QMS, Acuta ARIM, Oracle ERP/SCM, Rockwell SCADA, OSISoft PI Data Historian, Novatek Environmental Monitoring.
- Strong Validation skills with at least 5+ years of experience as a CSV lead.
- Experience in GMP manufacturing environment is a must.
- Experience with GAMP category 4 & 5 systems is a must.
- Strong facilitation skills to develop consensus and clarity, Ability to communicate and work independently with scientific/technical personnel
- Must have strong organizational skills and be able to execute and potentially manage projects to completion.
- Ability to work cross functionally with all levels of the organization.
- Project management or ASQ, Black Belt/Green Belt certification is a plus
- Active participation/knowledge of ISPE (GAMP) and/or ASQ standards a plus
- Strong understanding and working knowledge of FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, and EU Annex 11
- Proficient in MS Word, Excel, Power Point and other applications.
- Strong written and verbal communication skills.
- Bachelor’s Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology).
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself