Remote Associate Director, Clinical Quality & Governance

Biogen, Inc.

Northern (KY)

Hybrid

USD 148,000 - 204,000

Full time

14 days+

Application generator

Don’t send a generic resume — generate a resume and cover letter tailored to this exact role.

Get past ATS filters

Benefits offered by this job

Medical

Dental

Vision

Life insurance

Fitness & Wellness programs

Paid time off

401(k) matching

Tuition reimbursement

Job summary

Biogen is seeking an Associate Director of Clinical Quality Compliance to lead quality governance, risk management, and investigations across RDQC, RD&M, and clinical studies. This remote role prefers candidates in the Eastern or Central Time Zones to align with global operations.

You will drive continuous improvement of the Quality Management System, support regulatory inspections, and guide cross-functional teams on GCP expectations and quality standards, ensuring patient safety and data

Qualifications

Bachelor's degree in a scientific, healthcare, or related discipline.
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.

Responsibilities

Serve as the Clinical Quality & Compliance representative for assigned studies, programs, and functional areas, providing expert guidance on quality and compliance matters.
Support the development, maintenance, and continuous improvement of the Quality Management System by driving quality governance, process enhancement, and compliance initiatives.
Lead quality oversight activities for clinical studies and programs, including Study Risk Assessments (SRAs), quality health assessments, trend analyses, and risk mitigation planning.
Provide strategic leadership and consultation to study teams and functional stakeholders on GCP requirements, quality standards, and regulatory expectations.
Lead and approve investigations related to deviations, non-conformances, protocol compliance concerns, and other GCP-regulated quality events.
Oversee root cause analysis, CAPA development, implementation, and effectiveness verification to ensure sustainable issue resolution and continuous improvement.
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.
Identify emerging compliance risks and recommend proactive mitigation strategies that strengthen quality performance and organizational readiness.
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.