This is a remote position

About This Role​​​​​​​

The Senior Manager, External Audit will lead PO&T External (GMP, GOP) audit program including but not limited to all operational areas of PO&T (manufacturing, laboratory, Logistics, Affiliate functions, QA functions, etc...) focusing on GMP suppliers and supply chain operations (CMOs, CLOs, Raw Material, Distribution). The incumbent is responsible to support a team of Auditors who provide Quality Audits to ensure suppliers are manufacturing materials/product in accordance with applicable regulations and company policies and procedures.

What You'll Do

• Primarily responsible for Annual Audit schedule development and execution; develops annual risk based audit plan based on established risk assessment procedures and ensures audits are performed according to such schedule.
• Plan, conduct, and/or oversee audits to confirm that suppliers, partners, and service providers operate in accordance with GMP and other applicable worldwide regulatory requirements, and in compliance with Biogen requirements and expectations.
• Document audit observations and evaluates their potential impact.   This would include evaluating responses to audit findings and ensuring that completed audit reports and responses are maintained for future reference and analysis.  For own audits as well as those of direct reports.
• Review and approve audit reports and provide input on acceptability of responses to audit findings resulting from audits conducted by direct reports.
• Collaborate with internal customers to determine appropriate courses of action to take in response to vendor related concerns and observations.
• Serve as the Business Process Owner for the External Audit process, ensuring continuous monitoring and improvement of the processes.
• Manage, provides guidance, and develop a team of auditors with expertise across GMP regulations.

Who You Are

You are highly motivated and passionate about demonstrating and delivering excellence in auditing and continuous improvement. Strong judgment, critical thinking, attention to detail, organization and influencing skills in working with different stakeholders at all levels will be required.

Required Skills

• Bachelor's Degree in Life Sciences or related field + at least 10 years of direct experience (with at least 3 years of auditing experience)
• Excellent organizational, project management, written and verbal communication skills
• Strong analytical and negotiation skills
• Ability to work independently and to adjust to swift changes in priorities / projects
• Thorough knowledge of GMPs (FDA 21 CFR 210/ 211, EU Volume 4, ICH Q7, etc.)
• Ability to interact with employees at all levels of the organization including executive management critical

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.

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