Manager, GD (Global Development) Quality Management

Scorpion Therapeutics; Horsham (PA); Remote; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manager, Process & Personnel Qualification Management Expert within R&D Quality to drive compliance and quality in pharmaceutical processes through process improvement and digital transformation.

You will lead process development, map workflows, and train teams while partnering with Global Development to ensure GxP frameworks evolve with regulatory and business changes; manage timelines and risks, and influence the digital shift toward data-centric

Qualifications

• 5+ years' experience in pharmaceutical or device compliance within a matrix organization.
• Bachelor's in Science or Business; Master’s preferred.
• Strong knowledge of global clinical safety, pharmacovigilance, and quality standards.
• Proven project management, process design, and training development skills.
• Excellent communication and leadership abilities.

Responsibilities

• Lead process development, mapping, and training projects.
• Serve as a quality partner for Global Development, ensuring GxP frameworks adapt proactively to regulatory and business changes.
• Manage project timelines, risks, and stakeholder communication.
• Support digital evolution towards data-centric qualification systems.
• Potentially lead audits and inspections.

Skills

Project management

Process design

Training development

Leadership

Communication

Data analysis

Stakeholder engagement

GxP awareness

Education

Bachelor's in Science or Business

Master's degree preferred

Tools

BPM

SOP

ISO 9001

Quality validation

Job description

Role

Manager, Process & Personnel Qualification Management Expert within R&D Quality, focusing on driving compliance and quality in pharmaceutical processes through process improvement and digital transformation.

Responsibilities

• Lead process development, mapping, and training projects;
• Serve as a quality partner for Global Development, ensuring GxP frameworks adapt proactively to regulatory and business changes;
• Manage project timelines, risks, and stakeholder communication;
• Support digital evolution towards data-centric qualification systems;
• Potentially lead audits and inspections.

Requirements

• Minimum 5 years' experience in pharmaceutical or device compliance within a matrix organization;
• Bachelor's in Science or Business (Master's preferred);
• Strong knowledge of global clinical safety, pharmacovigilance, and quality standards;
• Proven project management, process design, and training development skills;
• Excellent communication and leadership abilities.

Preferred Skills

• BPM, SOP, quality validation, stakeholder engagement, data analysis, ISO 9001.

High-value

• Pharmaceutical industry, GxP compliance, process and training management, digital qualification systems, collaborative stakeholder engagement.

Work setup

Location flexible across multiple international sites with no travel specifics stated.