Associate Clinical Operations Compliance Director

Scorpion Therapeutics; Alameda (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Clinical Operations Compliance Director to lead GCP-aligned compliance across clinical programs, ensuring risk-based operational controls and audit readiness.

You will partner with QA, data management, and quality units to develop CAPA plans, oversee CRO performance, and drive training initiatives that strengthen inspection readiness.

Qualifications

• Bachelor's degree with 11+ years in biotech/pharma, or advanced degree with proportionate experience.
• Deep understanding of industry regulations, quality systems, and GCP standards.

Responsibilities

• Develop and execute risk management strategies.
• Support CAPA processes and closure.
• Collaborate with QA and cross-functional teams.
• Lead training initiatives and inspection readiness, including mock inspections and site monitoring oversight.

Skills

GCP compliance

Risk management

Vendor oversight

Inspection readiness

Regulatory knowledge

Education

Bachelor's degree in biotech/pharma

Advanced degree (MS/PhD)

Job description

Role

Associate Clinical Operations Compliance Director supporting clinical research compliance in biopharma, with a focus on GCP adherence, risk management, vendor oversight, and inspection readiness.

Responsibilities

• develop and execute risk management strategies
• support CAPA processes
• collaborate with QA and cross-functional teams
• lead initiatives in training and inspection readiness, including mock inspections and site monitoring oversight.

Qualifications

• Bachelor's degree with 11+ years in biotech/pharma, or advanced degree with proportionate experience
• deep understanding of industry regulations, quality systems, and GCP standards.

High-Value

focus on clinical operations compliance, risk and issue management, GCP training, and inspection readiness within biotech/pharma R&D; experience in maintaining audit readiness and oversight of CRO performance; strong communication and analytical skills; may involve working across clinical, data management, and quality units.

Work Setup

not explicitly stated, but environment implies office-based with collaborative space.