Strategic Regulatory Quality Program Manager

GeneFab; Alameda (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

GeneFab is seeking an experienced Quality Regulatory Program Manager to lead quality assurance and regulatory initiatives, ensuring compliance with regulatory requirements and driving continuous improvement for patient safety. This on-site role in Alameda, CA collaborates with clients and CROs to develop strategies for successful registrations and lifecycle management of complex products.

You will oversee submissions to regulators, prepare briefing materials, and manage interactions with

Qualifications

• Bachelor’s degree in a scientific discipline.
• 10+ years in compliance, quality, and CDMO/CMO management with regulatory lifecycle experience.
• 10+ years GMP/QA experience.
• Knowledge of aseptic manufacturing processes.
• Broad knowledge of FDA and international regulations related to GMPs and Biopharma.
• Experience with inspections by global regulatory agencies (FDA/EMA).
• Regulatory requirements across development stages and post-approval.
• Strong communication and project management skills.
• Ability to lead cross-functional teams.

Responsibilities

• Plan, prepare, and manage submissions to regulatory authorities with client collaboration.
• Prepare briefing materials for HA meetings and coordinate SMEs.
• Engage regulators and manage follow-up.
• Communicate regulatory strategy to stakeholders and senior management.
• Manage regulatory registrations and licenses (FDA, Oregon Board of Pharmacy).
• Develop and implement a comprehensive QA strategy aligned with goals and regulatory requirements.
• Provide strategic direction to the QA team and promote a culture of quality.
• Collaborate with cross-functional teams to integrate quality into manufacturing processes.
• Foster awareness of quality principles throughout the organization.
• Provide phase-appropriate regulatory guidance for trials and marketing applications.
• Collaborate with clients, consultants and CROs for appropriate regulator interactions.
• Manage the QA budget to ensure on-time, on-budget project delivery.
• All other duties as assigned.

Skills

Regulatory strategy

Quality improvement

Cross-functional collaboration

Project management

Communication skills

Negotiation

Leadership

Education

Bachelor's degree in science

Tools

Regulatory submissions software

Job description

GeneFab is seeking an experienced Quality Regulatory Program Manager to lead quality assurance and regulatory initiatives, ensuring compliance with regulatory requirements and driving continuous improvement for patient safety. This on-site role in Alameda, CA collaborates with clients and CROs to develop strategies for successful registrations and lifecycle management of complex products.

You will oversee submissions to regulators, prepare briefing materials, and manage interactions with