Sr Associate I, IT Quality
Job Description
About This Role
As part of the IT Quality team, the Sr. Associate I, IT Quality will deliver technically robust and compliant GxP computerized systems (CS) on cross-functional teams in support of SDLC activities. This individual will review and approve system life cycle deliverables (SDLC) and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities, including foundational and executable regulatory expectations for CS. The Sr. Associate I, IT Quality will work with peers locally and globally, when necessary to ensure practices are consistent with requirements and expectations set forth within the governing QMS. This role reports into the Sr Manager, IT Quality.
What You’ll Do
• Represent ITQ on cross-functional teams in support of SDLC activities for GxP applications, Drive the deployment of new or modified GxP systems through review and approval of life cycle deliverables in compliance with the governing regulations and procedures.
• Support the compliant implementation and maintenance of GxP computerized systems (i.e., new, upgrades, changes, etc.) to ensure the approach and execution aligns to industry as well as Biogen expectations. Support globally as ITQ representative.
• Support all Global Quality initiatives, including Data Integrity, Computerized Systems support and IT QMS implementation / remediation.
• Provide quality assurance oversight for system related issues (deviations, incidents, etc.) and application change controls.
• Support GxP audit readiness activities and assist with internal and external audits/inspections.
Qualifications
Who You Are
You are experienced in supporting implementation of IT computerized systems within a GxP environment. You are customer service oriented, possess strong communication skills and known for having good judgment in making critical business decisions. You are well versed in infrastructure and vendor hosting requirements supporting GxP systems and IT project management methodologies.
• At least 4 years of related experience. Background in Lifesciences and/or Pharma/Biotech industries or experience in a highly regulated industry required.
• Must have hands-on experience supporting implementation of IT computerized systems (i.e., IT systems) within a GxP environment either as a CSV and/or Quality lead.
• Ability to interpret regulatory guidance (GxP) and Biogen policies and procedures into executable and defendable lifecycle documentation.
• Depth of understanding of respective regulations governing computer systems and controls such as FDA’s 21 CFR Part 11, EMA’s Annex 11, and MHRA’s data integrity guidance.
• Understanding of risk-based methodologies as it relates to qualification and validation.
• Basic knowledge of underlying infrastructure requirements supporting GxP systems, and related IT technologies, e.g., SaaS, AWS, Azure, etc.
• Experience with IT project management methodologies, such as Agile, and supporting IT systems, such as ServiceNow, ALM, Veeva, etc.
• Bachelor’s Degree in Life Sciences, Engineering, or IT related discipline required
Additional Information
The base compensation range for this role is $73,000 to $109,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
