Regulatory Programs Lead — Quality & Compliance

GeneFab; Alameda (CA); On-site; USD 117,000 - 131,000; Full time

Job summary

GeneFab is seeking an experienced and dynamic Quality Regulatory Program Manager to lead our quality assurance and regulatory initiatives. You will ensure compliance with regulatory requirements, maintain high manufacturing quality, and drive continuous improvement for product quality and patient safety.

The role develops regulatory strategies for successful registration and lifecycle management of complex products.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 10+ years in compliance, quality, and CDMO/CMO management focused on regulatory documentation and lifecycle.
• 10+ years of GMP/QA experience.
• Knowledge of FDA and international regulations related to GMPs and Biopharma.
• Experience coordinating with clients/CROs and regulators.
• Strong communication, time management, and leadership skills.
• Experience with drug substances/products and inspections by global regulators.

Responsibilities

• Plan and manage submissions to health authorities (INDs, NDA/BLA) with clients.
• Prepare briefing materials for HA meetings and SMEs.
• Collaborate with regulators to resolve issues and support proactive interactions.
• Communicate regulatory strategy, risks, and plans to teams and management.
• Develop and implement QA strategy aligned with regulatory requirements.
• Lead QA team and promote quality excellence across manufacturing.
• Oversee QA budget and ensure timely project completion.

Skills

Regulatory strategy

GMP/QA experience

FDA/ICH knowledge

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree in science

Job description

GeneFab is seeking an experienced and dynamic Quality Regulatory Program Manager to lead our quality assurance and regulatory initiatives. You will ensure compliance with regulatory requirements, maintain high manufacturing quality, and drive continuous improvement for product quality and patient safety.

The role develops regulatory strategies for successful registration and lifecycle management of complex products.