Senior Associate II, Quality Audits

Biogen; North Carolina; Hybrid; USD 93,000 - 121,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Disability Insurance

Paid Vacation

Year-end Shutdown

Holidays & Personal Days

Sick Time

Parental Leave

401(k) Match

Employee Stock Purchase Plan

Tuition Reimbursement

Employee Resource Groups

Job summary

Biogen is seeking a Senior Associate II in Quality Audits to lead risk-based audits across the Regional Americas, ensuring regulatory compliance and adherence to ISO 13485 and FDA/EMA guidelines.

The role is hybrid and based at the RTP, NC office, with collaboration across internal and external stakeholders to strengthen the QMS and inspection readiness.

Qualifications

• 3+ years of experience in a regulated pharmaceutical/biotech/medical device environment.
• At least 2 years of auditing experience.
• Demonstrated experience with ISO 13485 and global GxP (FDA/EMA).
• Fluent in English.

Responsibilities

• Plan and conduct internal audits of sites ensuring GxP and ISO 13485 compliance.
• Audit external suppliers and contract manufacturers as needed.
• Document and evaluate observations and prepare inspection-ready reports.
• Manage multiple audits with timely reporting and action tracking.
• Support CAPA tracking and responses across stakeholders.
• Engage with site Quality and Operations teams to evaluate compliance.
• Communicate findings and drive corrective actions and remediation.

Skills

Audit experience

Regulatory compliance

Communication in English

Education

Bachelor of Science in Life Science/Engineering

Advanced degree

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.

Job Level: Professional

Additional 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, 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

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.

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.