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Medicines for All (M4ALL), 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 M4ALL’s inaugural Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs functions, in accordance with customer, M4ALL, and regulatory requirements. M4ALL 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.

M4ALL 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 M4ALL’s services.

• Translate strategic priorities, compliance requirements, and operational standards into actionable plans, systems, and capabilities that enable effective execution across the organization.
• Define, recruit, and develop a Quality Assurance, Quality Control, and Regulatory Affairs teams to enable successful commissioning and continuous operation of M4ALL’s kilogram scale cGMP site.
• Partner with the CBO, CMO, and CTO to ensure business, manufacturing, scientific and operational strategies are integrated and mutually reinforcing, quality- and compliance-aligned.

• Lead development, implementation, and maintenance of M4ALL’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).
• Serve as Chesterfield Site Management Representative, ensuring M4ALL’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.

• Responsible for developing and deploying regulatory strategy, submissions, and compliance reporting across M4ALL’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).

• Demonstrate strong communication (oral, written), organizational, and leadership skills.
• Collaborate with cross-functional teams, including Manufacturing Science & Technology, API Development Services (Process R&D, Analytical R&D), and Business Operations, to ensure alignment and effective communication.
• Foster a culture of teamwork, continuous improvement, and compliance.
• Set clear goals and expectations for team members, inspire and motivate them to achieve their best, provide opportunities for professional development, and manage performance effectively to ensure individual and team success.

Required:

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field, or an equivalent combination of education and relevant professional experience.
• In-depth knowledge of FDA 21 CFR Parts 210/211.
• Comprehensive understanding of applicable regulations and how to manage them effectively.
• Experience with quality tools and systems, including CAPA, deviations, change control, and audit processes.
• 5+ years of experience in small molecule drug substance manufacturing, in pharmaceutical services or pharmaceutical innovator contexts
• 7+ years of supervisory / leadership experience, specifically in Quality Management and/or Regulatory Affairs domains.
• Strong focus on precision and accuracy in documentation and processes.
• Skilled in root cause analysis and implementing effective corrective actions.
• Ability to design and implement training programs that equip professionals to operate effectively within regulatory, quality, and operational frameworks.
• Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.
• Ability to travel domestically and internationally.

• Mission-driven with a deep commitment to equitable access to medicines.
• Strategic operator who can balance vision with execution.
• Collaborative leader who values transparency, accountability, and continuous improvement. Adaptable and resilient in dynamic, high-impact environments.

• Advanced degree preferred.
• Experience building operational functions from the ground up or scaling in resource-constrained settings.

Annual Salary Range: Starting at $165,000, Commensurate with experience and unique qualifications

Reporting Structure: This role reports to the Chief Executive Officer and embodies everyday leadership, with an expectation to lead through actions, discussions, decisions, and interactions. As a role model within the organization, you will influence others by consistently demonstrating the values and behaviors that drive our mission forward.