Remote Associate Director, Quality & Governance (Clinical)

Lifelancer Ltd; United States; Remote; USD 148,000 - 204,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins

Fitness & Wellness programmes

Short- and Long-Term Disability

Vacation time and year-end shutdown

Company holidays & personal days

Tuition reimbursement

Employee stock purchase plan

Employee Resource Groups

Job summary

Biogen is seeking an Associate Director, Quality Assurance & Governance, to lead clinical quality governance and regulatory readiness across RDQC. This remote role emphasizes quality risk management, CAPA oversight, and inspection readiness while collaborating with cross-functional teams to protect study integrity.

The position supports vendor governance, quality metrics, and continuous improvement initiatives, with preference for Eastern or Central Time Zone proximity.

Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline.
• Minimum 10 years of experience in Clinical Operations, Clinical Quality, Compliance, or related functions.
• Extensive knowledge of GCP regulations and global development requirements.
• Demonstrated experience in quality oversight within clinical development programs.
• Experience leading investigations, root cause analyses, CAPA, and verification.

Responsibilities

• Provide expert guidance on quality and compliance for assigned studies and programs.
• Drive continuous improvement of the Quality Management System.
• Lead quality oversight activities for studies, including SRAs and risk mitigation planning.
• Provide strategic leadership on GCP requirements and regulatory expectations.
• Lead investigations and CAPA development and effectiveness verification.
• Drive vendor qualification, performance oversight, and quality risk assessments.
• Support audits and inspections through risk assessment and readiness activities.
• Identify emerging compliance risks and mitigation strategies.
• Monitor quality trends and provide actionable insights.

Skills

GCP compliance

Clinical quality leadership

Quality governance

Investigation & CAPA

Vendor oversight

Regulatory inspections

Risk management

Stakeholder management

Decision-making

Quality metrics

Education

Bachelor's degree in science/healthcare

Advanced degree preferred

Job description

Biogen is seeking an Associate Director, Quality Assurance & Governance, to lead clinical quality governance and regulatory readiness across RDQC. This remote role emphasizes quality risk management, CAPA oversight, and inspection readiness while collaborating with cross-functional teams to protect study integrity.

The position supports vendor governance, quality metrics, and continuous improvement initiatives, with preference for Eastern or Central Time Zone proximity.