Director, Analytical Quality Assurance

Scorpion Therapeutics; United States; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Paid time off

Job summary

Scorpion Therapeutics is seeking a leader for Analytical Quality Assurance to oversee external QC testing labs, stability programs, analytical methods, and related GMP operations. You will govern contract partners, drive regulatory-aligned quality decisions, and lead the Analytical QA team to foster a strong quality culture.

The role requires ensuring compliance with cGMP, GLP, ICH, and regulatory standards, plus coaching teams to maintain high analytical quality and robust CAPA processes.

Qualifications

• Evaluate analytical data, investigations, trends, and product quality risks.
• Oversee contract testing labs and external partners for performance monitoring and issue resolution.
• Strong communication, collaboration, organization, influencing, critical thinking, problem-solving, and independent decision-making.
• Lead/coach teams to build accountability, quality, and continuous improvement.

Responsibilities

• Provide quality oversight for contract QC testing labs, stability programs, analytical methods, and transfers.
• Review/approve analytical quality documents (SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs, quality assessments).
• Ensure analytical testing complies with cGMP, GLP, ICH, and applicable regulatory requirements (FDA/EMA).
• Oversee investigations for OOS/OOT/atypical results, deviations, and lab incidents; ensure timely resolution and CAPA recommendations.
• Oversee contract partners/labs (qualification, performance monitoring, audits, quality agreements, resolution of compliance/documentation issues).
• Maintain/improve systems for CAPA, change control, risk management, compliance, and analytical quality operations.
• Manage audits/inspections for analytical labs and testing activities (regulatory, customer, internal, cGMP compliance).
• Review/audit analytical data and CMC sections of NDA/global regulatory filings (as applicable).
• Manage direct reports in Analytical Quality Assurance.

Skills

Analytical data evaluation

Quality governance

Communication

Leadership coaching

Education

BS/BA in chemistry or microbiology

MS in chemistry or microbiology

PhD in chemistry or microbiology

Job description

Key Responsibilities

• Lead analytical quality oversight for external QC testing laboratories, stability programs, analytical methods, and related GMP analytical operations, ensuring scientific soundness, risk-based quality decisions, and regulatory compliance.
• Provide quality governance for contract partners and testing laboratories; partner cross-functionally with Manufacturing and external partners to support product lifecycle and regulatory priorities.
• Lead the Analytical Quality Assurance team and foster a strong quality culture.

Job Responsibilities

• Provide quality oversight for contract QC testing laboratory activities, stability programs, analytical method validation, and transfers.
• Review/approve analytical quality documents (SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs, quality assessments).
• Ensure analytical testing complies with cGMP, GLP, ICH, and applicable regulatory requirements (e.g., FDA/EMA).
• Oversee investigations for OOS/OOT/atypical results, deviations, and lab incidents; ensure timely resolution and appropriate CAPA recommendations.
• Oversee contract partners/labs (qualification, performance monitoring, audits, quality agreements, resolution of compliance/documentation issues).
• Maintain/improve systems for CAPA, change control, risk management, compliance, and analytical quality operations.
• Manage audits/inspections for analytical labs and testing activities (regulatory, customer, internal, cGMP compliance).
• Review/audit analytical data and CMC sections of NDA/global regulatory filings (as applicable).
• Manage direct reports in Analytical Quality Assurance.

Knowledge/Experience/Skills

• Evaluate analytical data, investigations, trends, and product quality risks for risk-based decisions.
• Oversee contract testing labs/external partners (performance monitoring, issue resolution, quality governance).
• Strong communication, collaboration, organization, influencing, critical thinking, problem-solving, and independent decision-making.
• Lead/coach teams; build accountability, quality, and continuous improvement.

Qualifications

• Pharmaceutical quality/analytical sciences/Quality Control/Quality Assurance or related GMP-regulated environment with progressive leadership.
• Preferred: BS/BA (12+ years), MS (10+ years), or PhD (8+ years) in chemistry, microbiology, or related.

Benefits (if eligible)

• Company-sponsored medical, dental, vision, and life insurance; paid time off.