Sr. Associate I, Corporate Quality

Job Description

Duties:

• Analyze science, engineering, business, and other data processing problems to implement and improve computer systems to deliver technically robust and compliant GxP computerized systems on cross-functional teams in support of system life cycle deliverables (SDLC) activities.
• Review and approve 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
• Work with peers locally and globally to ensure practices are consistent with requirements and expectations set forth within the governing Quality Management Systems.
• Represent IT Quality on cross-functional teams in support of SDLC activities for GxP applications and 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 of GxP computerized systems (i.e., new, upgrades, changes, etc.) to ensure the approach and execution aligns to industry as well as company expectations.
• Support all Global Quality initiatives, including Data Integrity, Computerized Systems and IT QMS implementation or 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 or inspections.
• Telecommuting permitted up to 100%.

Qualifications

Minimum Requirments:

Master’s degree (or foreign equivalent) in Engineering, IT, Life Sciences, Pharmaceutical Sciences, or a related field and 2 years of experience in the job offered or a related occupation in a Computer System Validation (CSV) or Quality role supporting the implementation of IT computerized systems within a GxP environment.

Must have demonstrable experience with each of the following:

• Interpreting GxP regulatory guidance and internal corporate policies and procedures into executable and defendable lifecycle documentation.
• Working with applicable local and global regulations governing computer systems and controls including FDA’s 21 CFR Part 11, EMA’s Annex 11, and MHRA’s data integrity guidance.
• Providing guidance on company policies and procedures and translating them into executable and defendable system lifecycle documentation.
• Using risk-based methodologies as they relate to qualification and validation.
• Knowledge of underlying IT infrastructure requirements supporting GxP systems, and ensuring that the underlying infrastructure of GxP systems is qualified per defined requirements.
• Reviewing and presenting regulatory requirements information, and effectively communicating the information orally and in writing, including: explaining methodology and consequences of decisions regarding quality requirements in lay terms; and translating requests into meaningful and relevant hypotheses to assist stakeholders with decision making.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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