Summary

As a Senior Associate II in Quality Audits, you will play a pivotal role within the Corporate Quality team, focusing primarily on audits in the Regional Americas. You will independently conduct risk-based audits to ensure compliance with regulatory requirements, international standards, and company quality expectations, primarily under ISO 13485 and applicable GxP regulatory frameworks including FDA and EMA guidelines. Your role will enhance our audit program by supporting inspection readiness and supplier qualification, while contributing to the continuous improvement of our Quality Management System (QMS). With a degree of autonomy and professional judgment, you will collaborate closely with internal and external stakeholders to maintain our high standards of quality compliance, making a significant contribution to the organization's overall business integrity and operational success.

Job description

About This Role

As a Senior Associate II in Quality Audits, you will play a pivotal role within the Corporate Quality team, focusing primarily on audits in the Regional Americas. You will independently conduct risk-based audits to ensure compliance with regulatory requirements, international standards, and company quality expectations, primarily under ISO 13485 and applicable GxP regulatory frameworks including FDA and EMA guidelines. Your role will enhance our audit program by supporting inspection readiness and supplier qualification, while contributing to the continuous improvement of our Quality Management System (QMS). With a degree of autonomy and professional judgment, you will collaborate closely with internal and external stakeholders to maintain our high standards of quality compliance, making a significant contribution to the organization's overall business integrity and operational success.

This is a hybrid role to be based at our offices in Research Triangle Park, NC.

What You'll Do

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.

Who You Are

You are detail-oriented and possess the ability to work autonomously while collaborating effectively with diverse teams. Your analytical mindset allows you to evaluate complex situations with precision, and your dedication to quality ensures compliance with rigorous standards. You excel in managing multiple audits concurrently, demonstrating efficiency and thoroughness in your work. Your strong communication skills facilitate clear interactions with stakeholders, fostering alignment and understanding of audit expectations and corrective actions.

Required Skills

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.

Preferred Skills

Advanced degree.
ASQ Certification.

Requirements

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

Medical, Dental & Vision
Life Insurance
Fitness & Wellness Programs
Short-Term Disability
Long-Term Disability
Paid Vacation
Paid Holidays
Paid Sick Time
Paid Maternity Leave
Paid Parental Leave
401(k) Matching
Employee Stock Purchase Plan
Tuition Reimbursement

Company overview

Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.