New · posted Oct 16
Biogen · Biotechnology
Senior Associate II, Quality Audits
- Research Triangle Park, NC
- Hybrid
- Full-time
- Senior & Principal
Open until filled
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. 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 need
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.
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.
Preferred Skillsnice to have
- Advanced degree.
- ASQ Certification.
Job Level: Professional
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.
Pay and benefits
$93,000 – $120,750 a year
Employer providedAdditional Information
The base compensation range for this role is: $93,000.00-$120,750.00
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.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Medical, dental, vision and life insurance
401(k) with company match
Employee stock purchase plan
Tuition reimbursement up to $10,000 per year
Paid maternity and parental leave
15days
Minimum 15 days paid vacation plus year-end shutdown
Where you'll work
Research Triangle Park, NCHybridOpen in Maps (opens in a new tab)
More jobs in Research Triangle Park, NC
From the posting
About Biogen
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. 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. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.
Equal opportunity, accessibility and legal noticesBiogen's statements, word for word
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Job intelligence
The context around this role
Live data · October 16, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in North Carolina8 roles publishing pay
Senior & Principal roles in the US285 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $93,000 | — | $120,750 |
| North Carolina (middle half) | $102,750 | $114,500 | $132,000 |
| All US (middle half) | $104,000 | $122,500 | $137,500 |
This role: Biogen's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 16, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 866 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Biogen's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance12
- Collaboration and leadership7
- Quality systems and risk6
- Lab testing and methods1
- Documentation and SOPs1
- Validation and qualification1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Biogen on Regulatory Jobs
- 11
- Open roles
- 11
- Distinct roles
- 3
- Locations
By discipline
- Quality8 73%
- Regulatory3 27%
By level
- Senior & Principal5 45%
- VP & Executive3 27%
- Director2 18%
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Senior Associate II, Quality Audits at Biogen
Open until filled. $93K–$121K a year, employer provided.