Remote Associate Director, Clinical Quality

Biogen; United States; On-site; USD 148,000 - 204,000; Full time

Job summary

Biogen seeks an Associate Director, Clinical Quality Compliance to provide strategic leadership within RDQC, driving QMS effectiveness across RD&M. The role includes governing vendor quality activities, FQR for clinical studies, risk management, CAPA oversight, inspection readiness, and continuous improvement initiatives.

The incumbent partners with cross-functional stakeholders to identify quality risks, implement sustainable solutions, and ensure global regulatory compliance, protecting

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.
• 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.
• Strong analytical, problem-solving, organizational, and decision-making skills.
• Excellent written, verbal, facilitation, and stakeholder management skills.
• Proven ability to influence without authority and effectively collaborate across multiple functions and organizational levels.
• Ability to independently manage competing priorities while maintaining a high level of quality and attention to detail.
• Clinical trial systems and process expertise required.

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.

Skills

GCP compliance

Quality governance

Stakeholder management

Root cause analysis

Vendor oversight

Quality systems

Education

Bachelor’s degree in science/healthcare

Tools

Clinical trial systems

Job description

Biogen seeks an Associate Director, Clinical Quality Compliance to provide strategic leadership within RDQC, driving QMS effectiveness across RD&M. The role includes governing vendor quality activities, FQR for clinical studies, risk management, CAPA oversight, inspection readiness, and continuous improvement initiatives.

The incumbent partners with cross-functional stakeholders to identify quality risks, implement sustainable solutions, and ensure global regulatory compliance, protecting