Vice President, Quality and Regulatory Affairs

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

Position Summary

is seeking an experienced Vice President of Quality & Regulatory Affairs to lead the Quality and Regulatory functions for a clinical-stage biotechnology company developing innovative cell-based therapies. This executive will have overall responsibility for establishing and maintaining a phase-appropriate Quality Management System, providing strategic regulatory leadership, and ensuring compliance across clinical development, manufacturing, testing, and external partners.

The VP will serve as a key member of the leadership team and will work closely with Clinical, CMC/Technical Operations, Manufacturing, R&D, and external partners to advance programs through clinical development and toward commercialization.

The successful candidate should be highly hands-on and comfortable operating in a small, fast-paced biotechnology company. This role requires both strategic leadership and the ability to independently assess issues, make risk-based recommendations, and drive execution. The VP will hold independent Quality authority for product disposition and release, maintained separately from Manufacturing and Technical Operations.

Key Responsibilities

Quality Leadership

• 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.

Regulatory Affairs 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.

Clinical Quality

• 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.

Vendor & Consultant Oversight

• 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.

Organizational 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.

Qualifications

Required

• 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.

Preferred

• Advanced degree (MS, PhD, PharmD, MD, or equivalent).
• Prior leadership experience specifically in cell therapy, regenerative medicine, xenotransplantation, or other advanced biologic modalities.
• Experience supporting products from Phase 1 through later-stage clinical development.
• Experience establishing or significantly upgrading a Quality Management System in a growing biotechnology company.
• Experience with regulatory strategy for manufacturing changes and comparability.
• Experience participating in FDA meetings and regulatory inspections.
• Experience preparing an organization for commercial-stage GMP requirements.

Leadership Profile

• Exercise independent scientific and regulatory judgment.
• Be comfortable challenging assumptions while remaining pragmatic and solution-oriented.
• Understand the distinction between regulatory requirements, regulatory precedent, and conservative industry practice.
• Identify practical paths forward rather than simply identifying compliance risks.
• Communicate clearly with executives and technical teams.
• Be willing to make decisions with incomplete information while appropriately managing risk.
• Balance patient safety, regulatory compliance, development speed, and business priorities.
• Operate effectively without a large corporate infrastructure.
• Take ownership of issues and drive them through resolution.

Key Near-Term Priorities

During the first 3-12 months, the VP of Quality & Regulatory Affairs will be expected to:

• Assess the current Quality and Regulatory organization and define an appropriate future-state structure.
• Strengthen management and oversight of the QA/QC organization.
• Review and prioritize improvements to the company’s QMS.
• Establish clear Quality governance and decision-making processes.
• Assume internal ownership of regulatory strategy and reduce reliance on external regulatory consulting.
• Support execution of the company’s Phase 1 clinical program.
• Strengthen regulatory and Quality oversight of clinical manufacturing.
• Establish a scalable vendor qualification and oversight program.
• Develop a regulatory strategy supporting future manufacturing, process, material, and supply-chain changes.
• Build an inspection-ready Quality culture appropriate for a growing clinical-stage cell therapy company.