Global Regulatory Quality Lead - External Manufacturing

Joulé; Collegeville (PA); Hybrid; USD 135,200; Full time

Benefits offered by this job

Health benefits

401(k) participation

Work from home flexibility

Job summary

A global pharmaceutical organization is seeking a Contractor Quality & Regulatory Lead to oversee product quality and compliance for external manufacturers. This role demands over 10 years of experience in GXP settings and requires expertise in regulatory affairs and quality management processes. The ideal candidate will work in a hybrid model, balancing remote oversight with necessary site visits. Strong leadership, communication, and project management skills are essential for success in this high-impact role.

Qualifications

• Minimally 10 years of experience in GXP setting or Regulatory Affairs.
• Expertise in external suppliers and Change Management processes.
• Knowledge of US, European, and global cGMPs.

Responsibilities

• Manage product quality for external contract manufacturers.
• Provide Quality Leadership and regulatory expertise.
• Assess quality of external suppliers' products.

Skills

GXP experience

Regulatory Affairs

Project Management

Strong Communication Skills

Problem Solving

Leadership Skills

Tools

QTS & eQMS modules

Job description

A global pharmaceutical organization is seeking a Contractor Quality & Regulatory Lead to oversee product quality and compliance for external manufacturers. This role demands over 10 years of experience in GXP settings and requires expertise in regulatory affairs and quality management processes. The ideal candidate will work in a hybrid model, balancing remote oversight with necessary site visits. Strong leadership, communication, and project management skills are essential for success in this high-impact role.