Executive Director, External Operations Quality

Scorpion Therapeutics

Newark (CA)

Hybrid

USD 260,000 - 380,000

Full time

6 days ago

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Job summary

Scorpion Therapeutics is seeking a senior leader to oversee external manufacturing quality, ensuring partners meet regulatory and quality standards across biopharma programs. You will drive quality governance, risk assessments, change controls, deviations and investigations, and lead technology transfers, analytical method validation, and supplier qualification.

This role guides audits and inspections readiness while mentoring the External Operations Quality team in a hybrid setup in the US,

Qualifications

Bachelor's degree in life sciences, engineering, pharmacy, or related field.
15+ years in GxP quality/compliance within biotech/pharma, with significant leadership experience in a commercial-stage organization.
Deep knowledge of global GxP regulations (FDA, ICH).
Experience with quality events, recalls, and data integrity.
Strong influencing skills and strategic leadership.

Responsibilities

Manage quality governance.
Perform risk assessments.
Oversee change controls, deviations, and investigations.
Lead technology transfers, analytical method validation, and supplier qualification.
Monitor external partner performance, conduct audits, and prepare for inspections.
Develop and mentor the External Operations Quality team.

Skills

GxP compliance

Regulatory knowledge

Leadership

Quality governance

Audits & inspections

Education

Bachelor's in life sciences, engineering, pharmacy, or related field

Job description

Role

Senior leader overseeing external manufacturing quality for a biopharma company, ensuring external partners meet regulatory and quality standards.

Responsibilities

manage quality governance
perform risk assessments
oversee change controls, deviations, and investigations
lead technology transfers, analytical method validation, and supplier qualification
monitor external partner performance, conduct audits, and prepare for inspections
develop and mentor the External Operations Quality team

Requirements

Bachelor's in life sciences, engineering, pharmacy, or related field
15+ years in GxP quality/compliance within biotech/pharma, with significant leadership experience in a commercial-stage organization
deep knowledge of global GxP regulations (FDA, ICH)
experience with quality events, recalls, and data integrity
strong influencing skills and strategic leadership

HighValue