Job Description

About This Role

The incumbent will provide guidance and support for the Quality oversight of regulatory health inspections and overall R&D audit management, in accordance with GCP and applicable global regulations and Biogen policies and procedures. Demonstrates global strategic leadership for quality and oversight of quality activities in Biogen R&D’s ongoing clinical research and development processes and programs, partnering with quality and compliance groups within and outside of R&D functions to enable transparency, escalation and risk minimization of R&D quality and compliance issues. Expected to lead and oversee the operational execution of core quality management processes, including inspections & general audit risk management by identifying quality risks from a spectrum of available resources; escalating risks as appropriate to drive resolution of major and critical audit findings, inspection findings and quality issues; overseeing relevant quality metrics; proactively assessing potential quality risks and recommends mitigating / remediating actions to quality leads within R&D functions.

What You’ll Do

• Serve as an accountable party for ensuring quality oversight of health authority regulatory inspections by assisting in developing an inspection management framework, engaging in inspection readiness activities with clinical study teams and staging of key documentation for inspector review.
• Responsible for driving resolution to regulatory health authority inspection findings and reporting in a timely manner to the relevant party.
• Leads the development and maintenance of the R&D Audit infrastructure, including audit risk assessment and the Annual Audit Plan, with oversight of end-to-end audit conduct by audit functional service providers or directly auditing stakeholders using applicable knowledge of GxP’s.
• Oversees the operational the process refinement efforts and potential execution of other quality management processes, including serious breach assessment, regulatory intelligence and proactive risk management.
• Responsible for overseeing relevant quality metrics; proactively assessing potential quality risks and recommends mitigating actions to drive quality metrics, in line with predetermined expectations.

Who You Are

You love to demonstrate knowledge of GxP regulations including data integrity requirements and apply them practically, helping Quality Assurance and Governance maintain the Quality Management Systems and uphold high standards for integrity and team collaboration. You also love to pay high attention to detail including having a proven ability to manage multiple, competing priorities and problem-solving skills.

Qualifications

Required Skills

• Bachelor’s degree required.
• 8+ years Clinical Trial experience working in the biotechnology or pharmaceutical industry required; work with CROs highly desirable.
• Experience with regulatory inspections and audits required.
• Experience with Quality Management Systems required.
• Must demonstrate extensive knowledge of the principles GCP regulations including data integrity requirements.
• Experience in process development and SOP writing.
• High attention to detail including proven ability to manage multiple, competing priorities, must have excellent negotiation and problem-solving skills.
• Ability to Influence the opinions and decision making of others internally or with external partners/vendor/customers

Preferred Skills

• Master's or PhD in Biology / Chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred.

Additional Information

The base compensation range for this role is $142,000 - $237,000. 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.