Medicines for All Institute · 3 days ago
Head of Quality & Regulatory Affairs
Richmond, VA
Full-time
Onsite
Director/Executive
7+ years expMedicines for All (M4ALL) is an entrepreneurial institute dedicated to improving global access to lifesaving medicines through innovative manufacturing processes. The Head of Quality & Regulatory Affairs will develop and administer M4ALL's Quality Assurance, Quality Control, and Regulatory Affairs functions, ensuring compliance with regulatory requirements while leading the establishment of a new cGMP facility.
EducationHigher EducationMedical
Responsibilities
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
Qualification
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
Preferred
Advanced degree preferred
Experience building operational functions from the ground up or scaling in resource-constrained settings
Company
Medicines for All Institute
The Medicines for All Institute, operating under the auspices of the Virginia Commonwealth University School of Engineering.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$18.7MKey Investors
Bill & Melinda Gates Foundation
2023-05-11Grant· $18.7M
Leadership Team
Mike Osberg
Chief Commercial and Strategy Officer
Recent News
2024-05-24
Richmond Times-Dispatch
2024-05-24
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