Director, Quality Assurance - Technical

Scorpion Therapeutics; United States; Remote; USD 180,000 - 250,000; Full time

Benefits offered by this job

Remote work

Travel opportunities (10-25% of time)

Job summary

Scorpion Therapeutics seeks a Director, Quality Assurance - Technical to lead GMP compliance, validation, and technical quality for contract manufacturing, testing, and storage of drug substances and products through Phase 3 validation and commercialization.

You will oversee validation efforts (process, facilities, equipment, computer systems), manage CSP oversight, review validation plans and protocols, and handle change controls, deviations, investigations, risk management, vendor

Qualifications

• Bachelor's in life sciences (Chemistry, Biology, Chemical Engineering preferred).
• 10+ years in FDA-regulated pharma/biotech industry.
• Deep knowledge of cGMPs and validation.

Responsibilities

• Lead validation efforts (process, facilities, equipment, computer systems).
• Manage and support CSP oversight.
• Review validation plans and protocols.
• Handle change controls, deviations, investigations, risk management.
• Vendor qualification.
• Collaborate with Technical Operations.

Skills

Leadership

Cross-functional collaboration

Project management

Education

Bachelor's in life sciences

Master's degree

Job description

Role: Director, Quality Assurance - Technical, overseeing GMP compliance, validation, and technical quality for contract manufacturing, testing, and storage of drug substances and products up to Phase 3 validation and commercialization.

Responsibilities

• lead validation efforts (process, facilities, equipment, computer systems)
• manage and support CSP oversight
• review validation plans and protocols
• handle change controls, deviations, investigations, risk management
• vendor qualification
• collaborate with Technical Operations

Requirements

• Bachelor's in life sciences (Chemistry, Biology, Chemical Engineering preferred)
• 10+ years in FDA-regulated pharma/biotech industry
• deep knowledge of cGMPs and validation

Preferred

• Master's degree
• experience with small molecule pharma
• strong project management
• cross-functional collaboration
• and leadership skills

High-Value

• GMP validation
• contract manufacturing oversight
• validation of processes/equipment/cleaning/test methods
• experience with pharma regulations
• international travel (10-25%)
• remote work from San Diego

Work setup

• primarily remote with some travel