Manager, Quality Assurance

Scorpion Therapeutics; California (MO); On-site; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics is seeking a Quality Assurance Leader to oversee GMP and GLP compliance within biopharma manufacturing. You will guide QA activities, ensure product quality, and drive continuous process improvement across manufacturing and analytical operations.

As a senior QA leader, you will supervise QA staff, manage regulatory adherence, and coordinate with R&D and contract manufacturers for audits and product launches, fostering a culture of quality and compliance.

Qualifications

• 7+ years in GMP environment
• BS/BA degree
• 5+ years with MS

Responsibilities

• Supervise QA staff
• Review controlled documents (SOPs, specifications)
• Manage compliance programs
• Analyze manufacturing and quality data
• Lead investigations and CAPAs
• Coordinate with R&D and contract manufacturers for new product launches and audits

Skills

GMP/GLP knowledge

QA principles

Industry standards

Six Sigma

FMEA

Project management

Communication

Technical writing

Education

Bachelor’s degree

Master’s degree

Tools

Six Sigma

FMEA

Job description

Role

Quality Assurance (QA) Leader overseeing GMP and GLP compliance within biopharma manufacturing.

Objectives

Ensure product quality, regulatory adherence, and continuous process improvement.

Responsibilities

• Supervise QA staff
• Review controlled documents (SOPs, specifications)
• Manage compliance programs
• Analyze manufacturing and quality data
• Lead investigations and CAPAs
• Coordinate with R&D and contract manufacturers for new product launches and audits.

Requirements

• 7+ years in GMP environment
• BS/BA degree
• 5+ years with MS.

Preferred skills

• Deep knowledge of GMPs/GLPs
• QA principles
• Industry standards
• Statistical tools like Six Sigma and FMEA
• Strong project management
• Communication
• Technical writing skills.

High-value specifics

• Focus on manufacturing quality in biopharma
• Experience with quality systems regulations
• Compliance audits.

Work setup and travel details

Not specified.