Director, Quality Assurance - Technical

Scorpion Therapeutics; United States; On-site; USD 180,000 - 230,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director of Quality Assurance - Technical to provide technical quality and compliance support for GMP contract manufacturing, testing, storage and distribution across Drug Substance and Drug Product programs.

The role leads validation efforts (process, facilities, FUE, shipping, cleaning, test methods) and oversees CAPA, deviations, OOS/OOT, vendor qualification, and change control with cross‑functional teams.

Qualifications

• Bachelor’s degree in life science or related field required.
• Master’s degree preferred.
• 10 years in an FDA-regulated industry in QA or related field.

Responsibilities

• Lead QA GMP functions overseeing CSPs for Drug Substance and Drug Product up to Phase 3.
• Lead validations: Process; Facilities, Utilities, Equipment; Shipping; Cleaning; Test Methods; CV.
• Oversee validation activities (VMP, URS, IQ/OQ/PQ, PV) and related reports.
• Support Change Control, Deviations/Quality Events, OOS/OOT, CAPA, Risk Management.
• Collaborate with Technical Operations to ensure compliant CSP documentation and policies.
• Participate in project core teams and track timelines/budgets.

Skills

cGMP knowledge

Regulatory knowledge

Project management

Line management

Quality systems

Communication & collaboration

Travel willingness

Education

Bachelor’s degree in life science or related field

Master’s degree preferred

Job description

Position Summary

The Director, Quality Assurance - Technical provides technical quality and compliance support and/or oversight of contract manufacturing, testing, storage and distribution, research and/or laboratory organizations.

Responsibilities

• Lead, manage, and perform critical QA GMP functions providing oversight of GMP Contract Service Providers (CSPs) for Drug Substance and Drug Product activities/projects leading up to Phase 3 Process Validation and Commercialization.
• Lead validation efforts including validations of: Process; Facilities, Utilities, Equipment (FUE); Shipping; Cleaning; Test Methods; Computer System Validation.
• Develop, execute, review, approve and/or oversee validation activities (e.g., VMP, VP, URS, Process FMEA, PC/PU studies, FAT, SAT, Commissioning, IQ/OQ/PQ, PV protocols/reports).
• Direct support of contract manufacturing/testing/storage/distribution organizations including Change Control, Deviations/Quality Events, OOS/OOT investigations, CAPA, Risk Management, vendor and contractor qualification.
• Collaborate with Technical Operations to review/approve CSP documentation; provide technical input to policies/SOPs/Work Instructions; review and approve Travere GxP documents as requested; ensure compliance with applicable laws/regulations/guidelines.
• Participate in project core teams; track progress vs. timelines/goals; perform other duties as needed.

Education/Experience Requirements

• Bachelor’s degree in life science or related field required (Chemistry/Biology/Chemical Engineering preferred); Master’s preferred.
• 10 years in an FDA-regulated industry in QA or related field; experience in biotech or pharmaceutical industry required.

Additional Skills/Experience (selected)

• Strong cGMP (CFR/ICH) knowledge; FDA/international regulatory knowledge.
• Excellent communication, organization, multitasking, collaboration, and attention to detail.
• Prior line management experience.
• Proven ability to manage complex project plans/timelines/budgets.
• Problem-solving, urgency, ability to work independently.
• Ability to travel 10-25%.
• Must be able to perform face-to-face/onsite in San Diego (not 100% remote).