Associate Director, Quality Assurance (GMP Operations)

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

Site-based role (Foster City, CA)

Knowledge

• In-depth knowledge of GMPs and/or GLPs; QA principles, concepts, industry practices, and standards.
• Understanding of Computer Systems Validation and ICH Guidelines.
• Excellent verbal, written, and interpersonal communication skills.
• Knowledge of Six Sigma, DMAIC, performance measures, and quality improvement statistics.
• Working knowledge of Risk Management tools (e.g., HACCP and/or FMEA).
• ASQ certification (Certified Quality Auditor/Engineer/Manager) or other industry-recognized professional organization.

Key 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.

Compliance, Audits & Inspections

• Participate in internal GMP audits and walkthroughs (Manufacturing, QC, Warehouse).
• Key Quality contact for regulatory inspections/internal audits; prepare and respond to findings.
• Monitor regulatory requirements and assess compliance risks.

Quality Systems & Documentation

• Approve GMP documentation (risk assessments, procedures, master batch records, specifications, analytical methods); drive continuous improvement.

Leadership & Collaboration

• Lead, develop, and mentor Quality personnel supporting GMP operations.
• Partner cross-functionally (Manufacturing, QC, Process Development, Engineering, Supply Chain, Quality management).
• Lead/support quality-related operational projects; provide on-call QA support as needed.
• Use risk-based decision making; maintain knowledge of Health Canada, FDA, and global GMP expectations.

Education & Experience (Requirements)

• 10+ years relevant GMP-environment experience with a Bachelor’s in science/related field OR 8+ years with an MS OR 5+ years with a PharmD/PhD.
• Extensive hands-on biologics GMP manufacturing and QC operations experience.
• Proven experience leading investigations, CAPA, and change management in GMP environment.
• Strong materials management, manufacturing/analytical methods, and GMP testing systems experience.
• Previous people management experience in Quality.
• Strong cross-functional collaboration and communication.

Preferred

• Experience supporting Health Canada, FDA, or other regulatory inspections.

Benefits (as stated)

• Salary range: $182,070.00 - $235,620.00; may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.