Associate Director, Quality Assurance - Technical

Scorpion Therapeutics; United States; On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Retirement match

Generous paid time off

Job summary

Scorpion Therapeutics seeks an Associate Director, Quality Assurance - Technical, to provide GxP Analytical quality/compliance support for analytical testing of products for clinical and commercial use. The role requires leading qualification, validation, and transfer activities for small and large molecules and acting as the main contact for cross-functional teams and contract vendors.

You will review/oversee validation activities, support risk assessments, and contribute to regulatory

Qualifications

• Bachelor’s degree in life science required.
• 8+ years in analytical function supporting drug/biologics development/commercialization.
• Direct GMP Quality Assurance and Analytical Qualification/Validation and/or Quality Systems experience.

Responsibilities

• Lead/support analytical qualification, validation, and transfer of methods for small and large molecules.
• Review/approve/oversee analytical validation activities (Method Validation Protocol, Raw Data Review, Method Validation Report, test methods).
• Primary point of contact for analytical questions/issues with cross-functional teams and contract vendors, including Laboratory Deviations, OOS/Out of Trend, Change Controls, and CAPA.
• Provide subject matter expertise for risk assessments; support mitigation recommendations.
• Support product stability programs (protocols, interim reports, raw data review, final reports).
• Support analytical review of data for regulatory submissions.

Skills

GxP Knowledge

cGMP

Regulatory Knowledge

Quality Assurance

Education

Bachelor’s degree in life science

Chemistry/Biology/Chemical Engineering preferred

Job description

Position Summary:

Associate Director, Quality Assurance - Technical, providing GxP Analytical quality/compliance support and/or oversight for analytical testing of product for clinical and commercial use.

Responsibilities:

• Lead/support analytical qualification, validation, and transfer of methods for small and large molecules.
• Review/approve/oversee analytical validation activities (Method Validation Protocol, Raw Data Review, Method Validation Report, test methods).
• Primary point of contact for analytical questions/issues with cross-functional teams and contract vendors, including Laboratory Deviations, OOS/Out of Trend, Change Controls, and CAPA.
• Provide subject matter expertise for risk assessments; support mitigation recommendations.
• Support product stability programs (protocols, interim reports, raw data review, final reports).
• Support analytical review of data for regulatory submissions.
• Provide technical input to policies/SOPs/work instructions to meet regulatory requirements and industry standards.
• Maintain knowledge of analytical regulatory requirements (FDA, ICH, EMA, USP).
• Support internal/external quality audits, inspections, audits, and due diligence as needed.

Education/Experience Requirements:

• Bachelor’s degree in life science or related field required; Chemistry/Biology/Chemical Engineering preferred.
• 8+ years in analytical function supporting drug/biologics development/commercialization.
• Direct GMP Quality Assurance and Analytical Qualification/Validation and/or Quality Systems experience.
• Broad cGMP knowledge (CFR/ICH) and international regulations/guidelines.

Additional Skills/Experience:

• Strong analytical problem-solving, communication, organization, urgency, attention to detail.
• Ability to work independently, manage multiple priorities; travel 10–20%.
• Face-to-face/onsite in San Diego required (not 100% remote).

Benefits/Compensation:

• Premium health, financial, work-life/well-being benefits; life insurance; disability; retirement match; generous paid time off.
• Target base pay range: $150,000–$195,000.