Manager, GD Quality Management (Open)

Scorpion Therapeutics; Horsham (PA); On-site; USD 120,000 - 165,000; Full time

Job summary

Johnson & Johnson's R&D Quality team in Horsham, PA is seeking a Manager of Process & Personnel Qualification Management to drive GxP compliance, process improvements, and digital transformation across quality systems.

You will lead qualification projects, partner with Global Development, and guide audits and inspections, while fostering cross-functional collaboration and data-driven decision making in a complex matrix environment.

Qualifications

• Bachelor's in Science or Business; Master's preferred.
• 5+ years in pharmaceutical/device compliance within large matrix organizations.
• Strong project management, process design, and training experience.
• Excellent communication skills.
• Regulatory knowledge in global pharmacovigilance and clinical safety.
• Analytical and leadership capabilities with a focus on collaboration and diversity.

Responsibilities

• Lead process development, mapping, training, and qualification projects.
• Serve as a quality partner for Global Development, facilitating collaboration and ensuring GxP compliance.
• Support digital initiatives to establish a data-centric qualification management system.
• Manage project timelines, risks, and reporting.
• Potentially lead audits and inspections.

Skills

Project management

Process design

Training

Communication

Regulatory knowledge

Leadership

Collaboration

Education

Bachelor's in Science or Business

Master's preferred

Tools

BPM

SOP development

Process optimization

Compliance management

Stakeholder engagement

Data literacy

Job description

Role: Manager of Process & Personnel Qualification Management within Johnson & Johnson's R&D Quality team, focusing on driving compliance, process improvement, and digital transformation in pharmaceutical quality systems.

Responsibilities

• lead process development, mapping, training, and qualification projects;
• serve as a quality partner for Global Development, facilitating collaboration among business units and ensuring GxP compliance;
• support digital initiatives to establish a data-centric qualification management system;
• manage project timelines, risks, and reporting;
• potentially lead audits and inspections.

Requirements

• Bachelor's in Science or Business (Master's preferred);
• 5+ years in pharmaceutical/device compliance within large matrix organizations;
• strong project management, process design, and training experience;
• excellent communication skills;
• regulatory knowledge in global pharmacovigilance and clinical safety;
• analytical and leadership capabilities with a focus on collaboration and diversity.

Preferred Skills

• BPM
• SOP development
• process optimization
• compliance management
• stakeholder engagement
• data literacy

High-Value

• pharmaceutical quality
• GxP compliance
• process improvement
• digital transformation
• project management
• cross-functional collaboration.

Location: Horsham, PA, and Titusville, NJ; specifics on travel not provided.