Biogen
Associate Director, Clinical Quality Compliance
Remote, USA, USA · Director
Sponsorship not specified$148k-$204kDetected 20 hours ago
GCPStakeholder ManagementExcelAuditingProcess ImprovementClinical TrialsFDA RegulatoryResearchLeadershipCommunicationProblem SolvingMentoringInternal AuditGxPRegulatory Affairs
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odds of building a lasting career here
59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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Files H-1B transfers
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About the role
- The Associate Director, Clinical Quality Compliance, serves as a strategic quality leader within R&D Quality & Compliance (RDQC), providing oversight, guidance, and expertise to support the effectiveness of the Quality Management System (QMS) across Research, Development, and Medical (RD&M).
- This role is responsible for driving a culture of quality and compliance through leadership of Vendor Quality Governance activities, Functional Quality Representation (FQR) for clinical studies, quality risk management, investigations, CAPA oversight, inspection readiness, and continuous improvement initiatives. The Associate Director partners closely with
Responsibilities
- Support the development, maintenance, and continuous improvement of the Quality Management System by driving quality governance, process enhancement, and compliance initiatives.
- Lead and approve investigations related to deviations, non-conformances, protocol compliance concerns, and other GCP-regulated quality events.
- Drive Vendor Quality Governance activities, including vendor qualification, performance oversight, quality risk assessments, issue management, and remediation activities.
- Partner with vendor quality representatives and internal stakeholders to ensure vendor compliance with global regulations, industry standards, and contractual quality obligations.
- Support internal audits, sponsor audits, investigator site audits, and regulatory inspections through preparation, risk assessment, response management, and inspection readiness activities.
- Lead cross-functional quality improvement initiatives that enhance operational effectiveness, inspection readiness, and regulatory compliance.
- Monitor quality trends and metrics, providing insights and recommendations to support informed decision-making and continuous quality improvement.
Requirements
- You are a strategic and collaborative quality professional with deep expertise in clinical development, GCP compliance, and quality systems.
- You are comfortable operating independently, influencing cross-functional stakeholders, and providing practical solutions to complex quality and compliance challenges.
- Minimum 10 years of experience in Clinical Operations, Clinical Quality, Compliance, Quality Assurance, or related pharmaceutical/biotechnology functions.
- Extensive knowledge of Good Clinical Practice (GCP) regulations and global clinical development requirements, including FDA regulations, ICH guidelines, and applicable international regulations.
- Demonstrated experience supporting quality oversight within clinical development programs and studies.
- Experience leading investigations, root cause analyses, CAPA development, implementation, and effectiveness verification.
- Strong understanding of Quality Management Systems (QMS), risk management principles, quality metrics, and continuous improvement methodologies.
- Experience supporting regulatory inspections, sponsor audits, and internal audit activities.
- Experience with vendor oversight and Vendor Quality Governance activities.
Nice to have
- The incumbent plays a critical role in protecting study participants, preserving scientific integrity, and ensuring the quality and reliability of clinical data throughout the development lifecycle.
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Paid Maternity and Parental Leave benefit
- Lead quality oversight activities for clinical studies and programs, including Study Risk Assessments (SRAs), quality health assessments, trend analyses, and risk mitigation planning.
- Bachelor's degree in a scientific, healthcare, or related discipline.
- 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
- Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team.
- We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine.
- 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.
Visa & Work Authorization
- Support internal audits, sponsor audits, investigator site audits, and regulatory inspections through preparation, risk assessment, response management, and inspection readiness activities
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.