Head of Quality & Regulatory Affairs, Autoimmunity

Werfenlife SA.; San Diego (CA); On-site; USD 240,000 - 280,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with employer match

Paid vacation

Paid sick leave

Performance-based bonus

Job summary

Werfenlife SA. is seeking a strategic Head of Quality & Regulatory Affairs for Autoimmunity in the United States. You will shape quality and regulatory strategy, lead global registrations, and manage QA/QC teams to ensure compliant product development and post-market success.

The role requires executive leadership, deep regulatory knowledge, and the ability to influence across functions to sustain Werfen’s standards and global market access.

Qualifications

• Bachelor’s degree in Life Sciences or related field is required.
• At least ten (10) years of Quality & Regulatory corporate leadership experience in a regulated environment.
• Extensive knowledge of US FDA regulations, global regulatory expectations, and ISO/QSRs.

Responsibilities

• Develop and coordinate quality and regulatory strategies for Autoimmunity products.
• Lead regulatory submissions including CE Mark, Canadian submissions, and international registrations.
• Oversee Quality Assurance, Quality Control, and complaint handling programs; ensure post-market surveillance.

Skills

Quality & Regulatory

FDA experience

Quality Systems

Leadership

Education

Bachelor’s degree in Life Sciences

Job description

Werfenlife SA. is seeking a strategic Head of Quality & Regulatory Affairs for Autoimmunity in the United States. You will shape quality and regulatory strategy, lead global registrations, and manage QA/QC teams to ensure compliant product development and post-market success.

The role requires executive leadership, deep regulatory knowledge, and the ability to influence across functions to sustain Werfen’s standards and global market access.