Senior Director, External Manufacturing Quality

Scorpion Therapeutics

Newark (CA)

Hybrid

USD 260,000 - 380,000

Full time

5 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.