VP, Quality & Regulatory Affairs — Cell Therapy Leadership

KLA Industries; Germantown (MD); On-site; USD 220,000 - 340,000; Full time

Job summary

KLA Industries is seeking an experienced Vice President of Quality & Regulatory Affairs to lead QA and Regulatory for a clinical-stage biotechnology company developing cell-based therapies. You will establish a phase-appropriate QMS, provide strategic regulatory leadership, and ensure GMP/GCP/GLP compliance across development, manufacturing, testing, and external partners.

The role requires hands-on leadership with risk-based decision making, maintaining independent quality authority for

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.
• 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; Internal and external audits; Batch records; Product disposition and release; Quality risk management.
• Ensure Quality systems evolve appropriately as the company progresses from early clinical development toward later-stage development and commercialization.
• Establish clear Quality metrics and regularly communicate significant risks, trends, and remediation plans to executive leadership.
• 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.
• Provide strategic guidance on regulatory pathways for cell therapy programs, including early clinical development, dose escalation, manufacturing changes, comparability, and later-stage development.
• Partner closely with Clinical, CMC, Preclinical, and R&D teams to ensure regulatory strategy is integrated into development plans.
• Translate regulatory feedback into clear, actionable internal plans.
• Maintain productive and transparent interactions with regulatory authorities.
• Provide regulatory and Quality leadership for cell therapy manufacturing and CMC development. Partner with Technical Operations on: Manufacturing process development; Process qualification and validation strategy; Analytical method development and validation; Specifications; Stability programs; Raw material controls; Comparability; Manufacturing site changes; Technology transfer; Supply chain controls.
• Assess regulatory impact of manufacturing changes and determine appropriate submission and implementation strategies.
• Ensure manufacturing controls and documentation are appropriate for the clinical stage while supporting progression toward commercial readiness.
• Provide Quality oversight of clinical development activities.
• Ensure appropriate GCP systems and vendor oversight are established.
• Partner with Clinical Operations on qualification and oversight of CROs, clinical sites, laboratories, and other service providers.
• Support inspection readiness as the clinical program expands.
• Establish a structured approach for qualification and oversight of CROs, CDMOs, testing laboratories, consultants, and other critical vendors.
• Evaluate external recommendations independently and ensure that final Quality and Regulatory strategies reflect the company's scientific, operational, and business objectives.
• Build sufficient internal expertise so that critical regulatory and Quality decisions are owned by the company rather than outsourced to consultants.
• Manage external consultants selectively to supplement, rather than replace, internal leadership.
• Build and mentor a high-performing Quality and Regulatory organization appropriate for the company's stage of development.
• Lead and develop existing QA/QC personnel and establish clear roles, responsibilities, decision rights, and escalation pathways.
• Recruit additional Quality and Regulatory personnel as the organization grows.
• Develop future leaders within the Quality organization.
• Promote a culture of accountability, scientific rigor, collaboration, and practical risk management.
• Work collaboratively across functions while maintaining appropriate Quality independence.

Skills

Quality leadership

Regulatory leadership

FDA interactions

GMP knowledge

Cell therapy

Quality systems

Risk management

CRO/CMO management

Program leadership

Strategic thinking

Education

Bachelor's degree in life sciences or related

Advanced degree preferred

Job description

KLA Industries is seeking an experienced Vice President of Quality & Regulatory Affairs to lead QA and Regulatory for a clinical-stage biotechnology company developing cell-based therapies. You will establish a phase-appropriate QMS, provide strategic regulatory leadership, and ensure GMP/GCP/GLP compliance across development, manufacturing, testing, and external partners.

The role requires hands-on leadership with risk-based decision making, maintaining independent quality authority for