Biogen
Sr. Associate III, Compliance - QRM Lead
Research Triangle Park, NC, USA · Senior
Sponsorship not specifiedDetected 1 day ago
Stakeholder ManagementGMPFDA RegulatoryLeadershipCommunication
Stay score
odds of building a lasting career here
38Risky
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
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
Context, not a finding about this posting: of this employer's 7 green-card filings in this occupation, 100% were for a worker who already held the job.
Files H-1B transfers
14 transfer filings in the last year, covering 14 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
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
- This role is responsible for ensuring the site always remains in a state of control and inspection-ready, supporting both domestic and international regulatory expectations.
Responsibilities
- Lead and manage the site Quality Risk Management (QRM) program, ensuring alignment with global policies and site procedures
- Maintain and oversee QRM repositories and lifecycle management within the Quality Management System
- Drive inspection management activities including scheduling, execution, response coordination, and regulatory requests
- Lead implementation and continuous improvement of risk management practices across the site
- Collaborate cross-functionally to support compliance, data integrity, and quality initiatives
- Support development of QRM training and enable risk facilitators across the organization
- Use data and established KPIs to monitor compliance and drive continuous improvement
Requirements
- You are a quality and compliance leader with strong expertise in risk management and a passion for driving continuous improvement in regulated manufacturing environments.
- Bachelor's degree in scientific, technical, or relevant discipline
- At minimum 6 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing environments
- Strong knowledge of cGMP regulations and global regulatory standards (e.g., FDA 21 CFR 210/211, ICH Q9)
- Experience with quality systems including risk management, change control, deviation management, and inspection readiness
- Master's degree (MBA, MS, or similar) with relevant experience
- Experience leading site-wide or global quality risk management programs
- Advanced knowledge of quality metrics and data-driven decision making
Nice to have
- Preferred skills
Compensation
- 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.
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Paid Maternity and Parental Leave benefit
- 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.