Senior Business Systems Analyst, Quality Systems (Contract)
ABOUT THE NEST
At bluebird, only two things matter – patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
Sr. BSA, Quality Systems (Contract)
ABOUT THE FLOCK
We are seeking a highly motivated Senior Business Systems Analyst, Quality Systems with strong skills in Veeva QMS and QualityDocs , Compliance Training LMS Software: ComplianceWire, and Quality Systems. This individual will work on IT Quality System deliverables related to system implementation projects, configuration, and change controls at bbb, partnering with Quality Assurance Validation, IT CSV, and business system owners across the organization. This position is responsible for assuring that bluebird bio’s GxP computerized systems are meeting business expectations and compliant with EU, and ICH guidelines and U.S. GxP regulations.
HOW YOU’LL FLY
As a Senior Business Systems Analyst, Quality Systems bird reporting to an IT Director, you'll help to bring more patients their bluebird days by:
- Act as IT BSA lead for IT validation systems projects executed cross-functional teams that include Business Owners, IT System Administrators and System Owners, and Quality Assurance on projects including on-premises IT infrastructure, cloud infrastructure, enterprise SaaS software, laboratory systems, clinical systems, quality documentation and management systems, and electronic learning management.
- Partner with IT CSV to validate IT Quality.
- Ensure that IT Quality systems are designed, validated, and operated in compliance with internal bluebird procedures and external regulatory requirements.
- Proactively maintain IT compliance across bluebird bio’s IT quality systems, identifying risks and proactive initiatives, when applicable.
- 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 IT Quality Systems.
- Provide technical support as the IT Quality Systems BSA SME during the development of system documentation such as user requirements, procedures, training modules, etc.
- Function as IT technical lead for evaluation of Upgrades and System Enhancements.
- Remain current in regulatory and industry trends.
- Participate in functional risk assessment for computer systems.
- Other related tasks as needed
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Strong Validation skills with at least 5+ years of experience as an IT BSA.
- 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, Green Belt certification is a plus.
- Experience ComplianceWire platform a plus.
- Experience with Veeva platform and applications 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, PowerPoint, MS Project, and other applications.
- Strong written and verbal communication skills.
- Bachelor’s Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology).
- Experience with JIRA and Confluence a plus
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.