Manager, Quality Systems & Technology - Remote, REMOTE, United States

Company Description

At Biogen, we pioneer in advancing science and strive to drive results whilst effectively managing risk. We are humble and curious and work towards creating a culture of integrity, trust, and treat everyone with openness, care, and dignity. The role of Manager in the Quality Systems & Technology team is aimed to provide quality oversight for computerized systems, technology, and solutions in accordance with GCP and applicable global regulations and Biogen policies and procedures. You will advocate for a risk-based approach to quality management, assess and manage risks as they emerge, and help drive efficiency while also ensuring compliance. You will be expected to build/enhance knowledge of regulatory trends and provide guidance to internal teams relating to the emerging regulations. An understanding of computer system validation and associated regulations combined with competencies in cross collaboration with R&D Quality & Compliance (RDQC), functional leads and IT operations is required.

Job Description

What You’ll Do

• Supporting quality oversight of computer systems and emerging technologies.
• Participating in process improvements and functional initiatives, as required.
• Overseeing and approving CAPAs / Effectiveness checks.
• Understanding of quality by design, risk assessments, quality measures and metrics.
• Understanding of the principles of data integrity.
• Supporting and engaging in cross-functional initiatives and ensuring timely execution of defined goals/objectives, including anticipating and identifying project risks, mitigations, and contingencies.
• Supporting audits and inspections. Supporting closure of regulatory agency commitments and CAPAs specific to systems and technology.

Qualifications

Who You Are

You will have core competencies around project management, quality issue management, process improvement, collaboration and decision making and a thorough understanding of the principles of data integrity, computer system validation and industry regulations.   

Required Skills

• Bachelor's Degree required. Master's or Advanced Degree preferred.
• 5-7 years of Clinical Trial/compliance/quality experience working in the biotechnology or pharmaceutical industry.
• Experience with regulatory inspections.
• Experience with Quality Management Systems.
• Must demonstrate extensive knowledge of the principles GCP regulations including data integrity requirements, computer system validation, GAMP 5, medical devices regulations etc.

Additional Information

The base compensation range for this role is $101,600 to $163,700. 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.