Manager, GD (Global Development) Quality Management

Scorpion Therapeutics; New Jersey; Hybrid; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics in New Jersey seeks a Manager, Process & Personnel Qualification Management Expert in R&D Quality to drive compliance and quality excellence across pharmaceutical development. You will lead process improvement, strengthen GxP frameworks, and partner with Global Development while guiding data-centric qualification systems; hybrid/remote with international scope.

The role demands 5+ years in pharma/device compliance, strong leadership and communication, and a track record of

Qualifications

• Bachelor's in Science or Business; Master's preferred.
• 5+ years in pharmaceutical/device compliance within a matrix org.
• Strong knowledge of global clinical safety, pharmacovigilance, and regulatory standards.
• Excellent communication, project management, and analytical skills.
• Proven leadership and collaboration abilities.

Responsibilities

• Lead process improvement projects including process mapping, training development, and qualification.
• Serve as a quality partner for Global Development; adapt GxP to regulatory changes.
• Support digital transformation to create data-centric qualification systems.
• Manage timelines, risks, issues, and stakeholder communication.
• Potentially lead audits and inspections.

Skills

Leadership

Project management

Communication

Analytical skills

Quality systems

Education

Bachelor's degree in Science or Business

Master's degree preferred

Job description

Role: Manager, Process & Personnel Qualification Management Expert in R&D Quality, focusing on driving compliance and quality excellence within pharmaceutical development.

Responsibilities

• lead process improvement projects including process mapping, training development, and qualification;
• act as a key quality partner for Global Development, ensuring GxP Quality Framework adapts to regulatory and business changes;
• support digital transformation initiatives to establish data-centric qualification systems;
• manage project timelines, risks, issues, and stakeholder communication;
• potentially lead audits and inspections.

Requirements

• Bachelor's in Science or Business (Master's preferred);
• at least 5 years of experience in pharmaceutical/device compliance within a matrix organization;
• strong knowledge of global clinical safety, pharmacovigilance, and regulatory standards;
• excellent communication, project management, and analytical skills;
• proven leadership and collaboration abilities.

Preferred Skills

• Business Process Management, SOP development, quality standards (ISO 9001), and process optimization.

High-Value: pharmaceutical compliance, process development, digital transformation, GxP frameworks, global development, audits, and inspections.

Work setup: likely hybrid or remote with international scope.