Head of Quality & Regulatory Affairs, Medicines Institute

Overview

Medicines for All Institute (M4

ALL), a part of Virginia Commonwealth University, is an entrepreneurial, impact-oriented institute dedicated to dramatically improving global access to lifesaving medicines. We achieve this through synthetic process innovation and advanced technology deployment to reduce costs and waste in small molecule drug substance manufacturing. Our work supports treatments for diseases such as TB, malaria, HIV, oncology, metabolic diseases, CNS, and rare diseases.

The Head of Quality & Regulatory Affairs is responsible for the development and administration of M4

ALL s inaugural Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs functions, in accordance with customer, M4

ALL, and regulatory requirements. M4

ALL is constructing a state-of-the-art kilogram scale cGMP facility in Chesterfield County, Virginia. This is a unique opportunity to be a part of the leadership team for our greenfield manufacturing site. The successful incumbent will help to build the organization, the facility and culture to enable a successful startup into cGMP manufacturing operations.

The Head of Quality & Regulatory Affairs works in close partnership with the Chief Manufacturing Officer (CMO), Chief Technology Officer (CTO), Chief Business Officer (CBO) to ensure the organization s infrastructure and operations are mission-aligned, resilient, and scalable. This role is ideal for a systems-oriented leader who thrives in dynamic, mission-driven environments and can translate strategic goals into operational capabilities.

M4

ALL is organized under the Office of the Senior Associate VP for Finance and Administration within VCU Health Sciences. The successful candidate will work closely with functional partners across the University and organization who support the delivery of M4

ALL s services.

• Leadership & Strategy Translate strategic priorities, compliance requirements, and operational standards into actionable plans, systems, and capabilities that enable effective execution across the organization.
• Leadership & Strategy Define, recruit, and develop a Quality Assurance, Quality Control, and Regulatory Affairs teams to enable successful commissioning and continuous operation of M4
  
  ALL s kilogram scale cGMP site.
• Leadership & Strategy Partner with the CBO, CMO, and CTO to ensure business, manufacturing, scientific and operational strategies are integrated and mutually reinforcing, quality- and compliance-aligned.
• Quality Management Lead development, implementation, and maintenance of M4
  
  ALL s Quality Management System (QMS) in compliance with FDA 21 CFR Parts 210/211 and global regulatory expectations (e.g., ICH Q7, Q9, Q10, Q11, Q12).
• Quality Management Serve as Chesterfield Site Management Representative, ensuring M4
  
  ALL s QMS complies with all applicable standards and foster a quality-focused culture. Operate as on-site leadership to facilitate the Quality Management System and management of the Quality team members.
• Lead internal and external audits including FDA inspections, customer inspections, and notified bodies.
• Ensure all site personnel are adequately trained on SOPs, regulatory requirements, and quality systems.
• Ensure quality documentation is accurate, complete, and audit-ready at all times.
• Lead, contribute to, and oversee the review and approval of batch records, deviations, investigations, corrective and preventive actions (CAPAs), and change controls.
• Establish, lead, and oversee supplier and raw material and component qualifications and ongoing audit programs.
• Resolve critical or major issues impacting product quality to management following standard procedures, ensuring timely resolution.
• Ensure effective deployment of environmental monitoring programs and maintenance of ISO-classified cleanroom environments.
• Manage and monitor compliance with equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation.
• Establish and measure performance against QA/QC CQAs, CCPs, ECs, and KPIs. Generate and present quality reports, metrics, and performance summaries to senior management.
• Oversee the QC stability program for raw materials, intermediates, and finished products.

• Regulatory Affairs Responsible for developing and deploying regulatory strategy, submissions, and compliance reporting across M4
  
  ALL s API Development Services portfolio.
• Serve as the principal point of contact for communications with the FDA and any other regulatory authorities.
• Keep current with Code of Federal Regulations (CFR) requirements for applications to DMF (Type II), IND, and (A)
  NDA documents.
• Prepare and maintain DMFs (Type II), IND, and (A)
  NDA documents, as well as annual updates / amendments for regulators, both domestic and global.
• Provide regulatory strategies and guidance to cross-functional teams throughout the API design, development, and manufacturing lifecycle (design, process research & development, cGMP manufacturing).

• Collaboration and…