Associate Director Quality

Scorpion Therapeutics; Pennsylvania; On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

10% travel

Job summary

Scorpion Therapeutics seeks an Associate Director of Quality to oversee site compliance within a biopharma manufacturing environment. The role focuses on maintaining regulatory standards and driving continuous quality improvement.

You will provide quality direction, manage critical documentation, and lead audits to ensure GMP compliance. The position also leads quality systems including change control and supervises Quality Specialists working with operations teams.

Qualifications

• Bachelor's in science or engineering with 8+ years of relevant experience.
• Strong knowledge of cGMP, FDA, and EMEA regulations.
• At least 2 years in GMP-controlled environments.

Responsibilities

• Provide quality direction.
• Manage documentation.
• Conduct audits.
• Ensure GMP compliance.
• Lead quality systems including change control.
• Supervise Quality Specialists partnering with operations teams.

Skills

Leadership

Quality direction

Audit coordination

Regulatory knowledge

Education

Bachelor's degree in science or engineering

8+ years of relevant experience

Job description

Role: Associate Director of Quality overseeing site compliance within a biopharma manufacturing environment, with a focus on maintaining regulatory standards and continuous quality improvement.

Responsibilities

• Provide quality direction
• Manage documentation
• Conduct audits
• Ensure GMP compliance
• Lead quality systems including change control
• Supervise Quality Specialists partnering with operations teams

Requirements

• Bachelor's in science or engineering with 8+ years of relevant experience
• Strong knowledge of cGMP, FDA, and EMEA regulations
• At least 2 years in GMP-controlled environments

Preferred

• Leadership of teams
• Experience with aseptic/sterile processing
• Lean principles (LSS Green Belt)
• Biologics or vaccine manufacturing experience

High-Value

• Biologics or vaccine production
• GMP compliance
• Quality management systems
• Regulatory audits
• Risk and deviation management
• Cross-functional collaboration
• 10% travel

Work Setup

On-site, with travel as needed.