Senior Director, External Manufacturing Regulatory Compliance

Scorpion Therapeutics; Spring House (PA); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson is seeking a senior leader to drive enterprise regulatory compliance across its External Manufacturing network within Innovative Medicine. The role focuses on embedding proactive compliance culture, strengthening programs, and increasing visibility of risks across a global matrixed organization.

The position requires 15+ years in GMP environments, with at least a decade in leadership involving external manufacturing and compliance oversight.

Qualifications

• Bachelor's in life sciences, engineering, pharmacy, or related field.
• 15+ years of GMP experience in pharma/biotech, with 10+ years in external manufacturing leadership.
• Proven leadership in regulatory compliance and inspection readiness.

Responsibilities

• Develop compliance strategies aligned with corporate goals.
• Provide independent risk assessments for external manufacturing partners.
• Oversee inspection readiness across the external manufacturing network.
• Lead oversight of contract manufacturers, labs, and suppliers.

Skills

Leadership

Regulatory compliance

GMP oversight

Risk management

Education

Bachelor's in life sciences or related

Job description

Lead enterprise regulatory compliance oversight

Lead enterprise regulatory compliance oversight for Johnson & Johnson's External Manufacturing network within the Innovative Medicine sector. Objectives include strengthening compliance programs, enhancing visibility of risks, supporting inspection readiness, and fostering organizational learning.

Responsibilities

• developing compliance strategies aligned with corporate goals
• providing independent risk assessments
• overseeing inspection readiness
• managing external manufacturing partner oversight across contract manufacturers, labs, and suppliers

Qualifications

• Bachelor's in life sciences, engineering, pharmacy, or related
• 15+ years of GMP experience in pharma, biotech, or biologics, with at least 10 years in leadership roles involving external manufacturing and compliance oversight

Preferred Expertise

• supporting major inspections
• managing supplier quality systems
• experience with global health authorities

High-value specifics

• focus on GMP compliance
• external manufacturing oversight
• inspection readiness
• risk management
• cross-functional leadership in a global, matrixed environment

The position reports to senior leadership and involves strategic influence across the organization to embed proactive compliance culture.