Associate Director, GxP Electronic Systems Quality Assurance

Scorpion Therapeutics; California (MO); On-site; USD 186,000 - 233,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Leader to head the Global Quality Systems Monitoring & Excellence program within a late-stage oncology biopharma, ensuring GxP compliance, governance, and continuous improvement of the QMS across development and commercial readiness.

The role emphasizes audit readiness, inspection support, CAPA governance, and leading a high-performing QA/QMS team with deep knowledge of FDA/EMA/ICH regulations and eQMS platforms like Veeva Vault.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or related field.
• 10+ years in QA/QMS roles in biotech/pharma, with regulatory inspection experience.
• Strong knowledge of FDA, EMA, ICH regulations.
• Experience with eQMS (e.g., Veeva Vault).
• Leadership and stakeholder management skills.

Responsibilities

• Oversee audit readiness, inspection support, KPI/KQI analysis, CAPA governance, critical issue management, process standardization, and digital quality initiatives using AI and data analytics.
• Build and lead a high-performing team.

Skills

Audit readiness

CAPA governance

Regulatory knowledge

Team leadership

Data analytics

QMS management

Education

Bachelor's degree in Life Sciences/Pharmacy or related field

Tools

eQMS (e.g., Veeva Vault)

Job description

Role

Lead the Global Quality Systems Monitoring & Excellence program within a late-stage oncology biopharma developing RAS‑targeted therapies, ensuring compliance, governance, and continuous improvement of QMS.

Responsibilities

• oversee audit readiness, inspection support, KPI/KQI analysis, CAPA governance, critical issue management, process standardization, and digital quality initiatives using AI and data analytics;
• build and lead a high-performing team.

Requirements

• Bachelor's in Life Sciences, Pharmacy, or related field;
• 10+ years in QA/QMS roles in biotech/pharma, with regulatory inspection experience;
• strong knowledge of FDA, EMA, ICH regulations;
• experience with eQMS (e.g., Veeva Vault);
• leadership and stakeholder management skills.

Preferred

• experience supporting late‑stage clinical and commercial products;
• knowledge of digital transformation and analytics;
• certifications like ASQ CQA or RAC.

High‑Value

• focus on GxP compliance, regulatory inspection readiness, digital quality platforms, and leadership in a fast-paced, regulated environment.

Location

onsite Redwood City, CA, with a salary range of $186K-$233K, commensurate with experience.