Associate Director, Clinical Quality Compliance

Scorpion Therapeutics; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Biogen is seeking an Associate Director, Clinical Quality Compliance to serve as a strategic quality leader within R&D Quality & Compliance, ensuring GCP adherence and a culture of quality across clinical development.

You will oversee vendor quality governance, lead clinical study quality oversight, and drive CAPA, investigations, and inspection readiness while partnering with internal teams and vendors to mitigate risk and ensure global regulatory compliance.

Qualifications

• Bachelor's degree in a scientific or healthcare discipline.
• 10+ years in Clinical Operations, Quality, or Compliance within pharma/biotech.
• Extensive GCP knowledge, experience with investigations, vendor oversight, and regulatory inspections.

Responsibilities

• Oversee Vendor Quality Governance, lead clinical study quality oversight, support QMS improvements, manage investigations, CAPA, and inspection readiness.
• Partner with internal teams and vendors to mitigate risks and ensure compliance with global regulations.
• Monitor quality metrics and drive continuous improvement initiatives.

Skills

GCP knowledge

Investigations

Vendor oversight

Regulatory inspections

Leadership

Analytical skills

Stakeholder management

Education

Bachelor's degree in life sciences or healthcare

Tools

Trial systems

Job description

Role: Associate Director, Clinical Quality Compliance at Biogen, serving as a strategic quality leader within R&D Quality & Compliance to ensure GCP adherence and a culture of quality across clinical development.

Responsibilities

• oversee Vendor Quality Governance, lead clinical study quality oversight, support QMS improvements, manage investigations, CAPA, and inspection readiness
• partner with internal teams and vendors to mitigate risks and ensure compliance with global regulations
• monitor quality metrics and drive continuous improvement initiatives

Requirements

• bachelor’s degree in a scientific or healthcare discipline
• 10+ years in Clinical Operations, Quality, or Compliance within pharma/biotech
• extensive GCP knowledge, experience with investigations, vendor oversight, and regulatory inspections
• strong leadership, analytical, and stakeholder management skills

Preferred

• advanced degree
• trial systems expertise
• experience as Functional Quality Representative
• regulatory inspection management

High Value

• clinical development
• GCP compliance
• vendor governance
• investigations and CAPA
• inspection readiness
• risk management

Location

location ideally within Eastern or Central Time Zones; remote work with no travel specified.