Chief Quality & Regulatory Officer - Cell Therapy

Planet Pharma; Germantown (MD); On-site; USD 200,000 - 260,000; Full time

Job summary

Planet Pharma seeks an experienced Vice President of Quality & Regulatory Affairs to lead Quality and Regulatory functions for a clinical-stage biotechnology company developing innovative cell-based therapies. This executive will establish and maintain a phase-appropriate QMS and provide strategic regulatory leadership across clinical development, manufacturing, testing, and external partners.

The VP will collaborate with Clinical, CMC/Technical Operations, Manufacturing, R&D, and external

Qualifications

• Bachelor’s degree in life sciences, engineering, pharmacy, or related discipline; advanced degree preferred.
• Typically 15+ years of progressive experience in biotechnology, pharmaceutical, or cell/gene therapy development, including significant leadership experience.
• Direct Quality and/or Regulatory leadership experience with cell therapy, gene therapy, or other advanced / complex biological products — required.
• Demonstrated experience leading Quality and/or Regulatory functions in a clinical-stage biotechnology company.
• Strong understanding of GMP requirements for clinical manufacturing.
• Experience with IND-stage programs and direct interaction with FDA.
• Demonstrated experience developing regulatory strategy and responding to FDA questions or information requests.
• Strong knowledge of Quality systems, including deviation management, CAPA, change control, supplier qualification, audits, and product disposition.
• Experience supporting clinical manufacturing and release of investigational products.
• Experience managing CROs, CDMOs, laboratories, and regulatory/Quality consultants.
• Ability to operate effectively in a small company where executives are expected to work both strategically and hands-on.

Responsibilities

• Provide executive leadership and oversight for Quality Assurance and Quality Control.
• Establish, maintain, and continuously improve a phase-appropriate Quality Management System (QMS) supporting clinical-stage cell therapy development.
• Ensure compliance with applicable GMP, GCP, GLP, and other relevant FDA regulatory requirements.
• Provide independent Quality oversight of manufacturing, testing, release, clinical supply, and vendor activities.
• Maintain appropriate Quality independence from Manufacturing and Technical Operations, including independent authority for product disposition and release.
• Oversee deviations and investigations, change controls, out-of-specification/out-of-trend investigations, product complaints, document control, training systems, supplier qualification, audits, batch records, product disposition and release, quality risk management.
• Develop and execute the company’s US regulatory strategy, with expansion into global regulatory activities as programs advance.
• Serve as a primary strategic interface with the FDA and other regulatory authorities.
• Lead preparation and review of IND submissions and amendments, FDA information requests, meeting packages, annual reports, clinical protocol amendments, Investigator’s Brochures, CMC regulatory submissions, safety-related regulatory communications.

Skills

Quality leadership

Regulatory strategy

FDA interactions

GMP/GCP knowledge

Leadership

Risk management

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Planet Pharma seeks an experienced Vice President of Quality & Regulatory Affairs to lead Quality and Regulatory functions for a clinical-stage biotechnology company developing innovative cell-based therapies. This executive will establish and maintain a phase-appropriate QMS and provide strategic regulatory leadership across clinical development, manufacturing, testing, and external partners.

The VP will collaborate with Clinical, CMC/Technical Operations, Manufacturing, R&D, and external