Associate Director, GMP QA Operations & Compliance

Scorpion Therapeutics; United States; On-site; USD 182,000 - 236,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Company-sponsored medical/dental/vison

Job summary

Scorpion Therapeutics in Foster City, CA is seeking a senior Quality Assurance leader to oversee GMP manufacturing, QC testing, and investigations across the product lifecycle.

You will lead internal and external QA activities, ensure cGMP compliance with FDA/Health Canada expectations, drive CAPAs, risk management, and continuous improvement, and mentor QA staff in a fast-paced biologics environment.

Qualifications

• 10+ years GMP/QA leadership experience in biologics or pharma.
• Hands-on experience with QC operations and manufacturing oversight.
• Proven track record leading investigations, CAPA, and change controls.
• Strong cross-functional collaboration and regulatory liaison skills.
• ASQ certification or equivalent professional credentials.

Responsibilities

• Provide Quality Assurance oversight of GMP manufacturing and QC testing from master cell bank to drug product.
• Define and oversee external QC laboratories; ensure qualification/verification/validation comply with cGMP, ICH, and internal standards (review/approve protocols, reports, and methods).
• Review/approve laboratory investigations (e.g., OOS/OOT/deviations); ensure root cause analysis, robust CAPA, and decisions aligned to product quality/disposition.
• Apply Quality Risk Management to oversee risk assessments with Manufacturing and QC.
• Partner to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.
• Justify/document quality risk decisions per internal procedures and regulatory expectations.
• Resolve quality issues across manufacturing, laboratory activities, and material receipt/shipping; oversee digital manufacturing workflow implementation.
• Review/approve manufacturing and test records, deviations, investigations, change controls, and CAPA for timely product disposition.
• Evaluate operational and quality risks for new product introductions.

Skills

GMP/GLP knowledge

Computer Systems Validation

Communication skills

Quality improvement statistics

Risk management tools

Education

ASQ certification

Job description

Scorpion Therapeutics in Foster City, CA is seeking a senior Quality Assurance leader to oversee GMP manufacturing, QC testing, and investigations across the product lifecycle.

You will lead internal and external QA activities, ensure cGMP compliance with FDA/Health Canada expectations, drive CAPAs, risk management, and continuous improvement, and mentor QA staff in a fast-paced biologics environment.