VP, Quality & Regulatory Affairs - Cell Therapy

Clinical Dynamix, Inc.; Germantown (MD); On-site; USD 250,000 - 350,000; Full time

Job summary

Clinical Dynamix, Inc. seeks a highly experienced Vice President of Quality & Regulatory Affairs to lead QMS, regulatory strategy, and compliance across clinical development, manufacturing, testing, and external partners.

The VP will provide hands-on leadership in a small, fast-paced biotechnology setting, ensuring independence of Quality for product disposition and release while driving programs toward commercialization and FDA readiness.

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.
• Direct Quality and/or Regulatory leadership experience with cell therapy, gene therapy, or other advanced/complex biological products — required.
• 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, OOS/OOT investigations, product complaints, document control, training systems, internal and external audits, batch records, product disposition and release, quality risk management.
• Establish clear Quality metrics and communicate risks, trends, and remediation plans to executive leadership.

Skills

Executive leadership

QA/QC leadership

GMP/GCP/GLP knowledge

FDA regulatory

Regulatory strategy

Risk management

Cross-functional collaboration

Independent decision making

Education

Bachelor's degree in life sciences/related field

Advanced degree preferred

Job description

Clinical Dynamix, Inc. seeks a highly experienced Vice President of Quality & Regulatory Affairs to lead QMS, regulatory strategy, and compliance across clinical development, manufacturing, testing, and external partners.

The VP will provide hands-on leadership in a small, fast-paced biotechnology setting, ensuring independence of Quality for product disposition and release while driving programs toward commercialization and FDA readiness.