Biogen
Senior Associate II, Quality Audits
Research Triangle Park, NC, USA · Senior
Stay score
odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Files H-1B transfers
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
Community outcomes
No reports yet — be the first to help the next applicant.
About the 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.
- 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).
- This is a hybrid role to be based at our offices in Research Triangle Park, NC.
Responsibilities
- Support the planning and conducting of internal audits of sites, ensuring adherence to GxP requirements and ISO 13485 standards.
- 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.
- Collaborate with stakeholders to drive remediation and continuous improvement initiatives.
Requirements
- You are detail-oriented and possess the ability to work autonomously while collaborating effectively with diverse teams.
- Required Skills:
Nice to have
- Preferred Skills:
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.
- Advanced degree.
- ASQ Certification.
- Job Level: Professional
- Additional Information
- The base compensation range for this role is: $93,000.00-$120,750.00
- Medical, Dental, Vision, & Life insurances
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Paid Maternity and Parental Leave benefit
- Contribute to inspection readiness activities and health authority audit responses.
- 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)
- Employee stock purchase plan
- Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Company info
- We are a global team with a commitment to excellence, and a pioneering spirit.
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- 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.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.