Senior Associate II, Quality Audits

Biogen

. Support the planning and conducting of internal audits of sites, ensuring adherence to GxP requirements and ISO 13485 standards .

Posted 10/15/2026full-timeResearch Triangle Park • North Carolina • United StatesSenior💰 $93,000 - $120,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in conducting internal and external audits in compliance with GxP requirements and ISO 13485 standards, with a strong focus on risk management and stakeholder collaboration. Proficient in preparing inspection-ready audit reports and managing corrective action plans (CAPAs) to drive continuous improvement.

Highest-signal resume keywords

ISO 13485 ComplianceGxP Regulatory FrameworksAudit ManagementCAPA TrackingStakeholder Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Internal AuditingExternal AuditingRisk-Based AuditingAudit ReportingRegulatory Compliance

Soft Skills

Effective CommunicationCollaborationProblem Solving

Certifications & Qualifications

ASQ Certification

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceInspection ReadinessHealth Authority Audits

About the role

Key responsibilities & impact

Support the planning and conducting of internal audits of sites, ensuring adherence to GxP requirements and ISO 13485 standards
Plan and execute risk-based audits for external suppliers, contract manufacturers, and service providers, if needed
Document and evaluate audit observations, preparing inspection-ready audit reports
Manage concurrent audits effectively, ensuring timely completion and thorough reporting
Support tracking and review of audit responses and CAPAs, driving alignment across stakeholders
Engage with site and affiliate Quality and Operations teams to evaluate compliance
Communicate findings and expectations, ensuring timelines for corrective actions
Collaborate with stakeholders to drive remediation and continuous improvement initiatives
Interface with supplier Quality and technical teams during external audits
Contribute to inspection readiness activities and health authority audit responses

Requirements

What you’ll need

Bachelor of Science in Life Science, Engineering, or related technical discipline
Minimum of 3 years’ experience in a regulated pharmaceutical, biotechnology, or medical device environment
At least 2 years auditing experience
Demonstrated experience with ISO 13485 and global GxP regulatory frameworks (FDA, EMA)
Fluent in English
Advanced degree (preferred)
ASQ Certification (preferred)

Benefits

Comp & perks

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Short term and long-term incentives, including cash bonus and equity incentive opportunities