Associate Director, International Auditing

Responsibilities

• Lead the planning and execution of a risk-based audit program for internal manufacturing sites, affiliates, CMOs, suppliers, and service providers across Europe and RoW.
• Ensure audits are conducted in accordance with global Quality policies, regulatory requirements, and industry standards.
• Oversee audit execution, including scope definition, auditor assignment, on-site/remote activities, and reporting.
• Review and approve audit reports for quality, consistency, and accuracy.
• Ensure timely and effective response to audit observations, including corrective and preventive actions (CAPAs).
• Lead and develop a regional audit team of 4-7 direct reports, setting performance goals and providing coaching.
• Serve as the primary Quality audit point of contact for European and RoW stakeholders.
• Drive continuous improvement of audit processes, tools, and metrics.
• Support regulatory inspections and due diligence activities as required.
• Collaborate with stakeholders to drive remediation and continuous improvement.
• Required Skills:
• Bachelor's Degree in Science, Engineering, Pharmacy, or related discipline required; advanced degree preferred or equivalent combination of education and experience.
• 12-15 years of experience in Quality Assurance and GxP auditing within the pharmaceutical or biotechnology industry.
• Minimum 5 years of people management experience and demonstrated leadership of complex, international audit programs.
• Experience auditing manufacturing sites, CMOs, suppliers, and service providers in global regulatory environments.
• Proficiency in English.
• Preferred Skills:
• Advanced terminal degree (MD, PhD, PharmD).
• Experience with ISO 13485 and global GxP regulatory frameworks (FDA, EMA).
• Job Level: Management
• Why Biogen?

Benefits

Additional Information

About This Role: As the Associate Director of International Auditing, you will spearhead the planning, execution, and oversight of Quality audits across manufacturing sites, affiliates, contract manufacturers, suppliers, and service providers throughout Europe and the Rest of World (RoW). Situated in Baar, Switzerland, this role is pivotal in ensuring our audit program is robust, risk-based, and aligned with global quality standards to uphold regulatory compliance, patient safety, and product quality. Reporting to the Director of Quality Risk, Auditing and Governance, you will lead a team of auditors, fostering collaboration with global Quality functions to ensure audit outcomes drive effective risk mitigation and continuous improvement. Your leadership will enhance our Quality Management System and contribute to the organization's overall success. This role requires approximately 25% international travel across Europe and RoW to support on-site audits, stakeholder engagement, and regulatory activities.

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