Department: Research & Development (R&D)
Reports to: President, R&D
Location: Remote Work, US only
Position SummaryAt Sabin, R&D is focused on advancing vaccines through development and addressing unmet needs. The Vice President, Quality provides strategic and operational leadership for GxP quality across Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), and Good Laboratory Practice (GLP).
This role builds and sustains a phase-appropriate Quality Management System (QMS) for a virtual nonprofit organization, ensuring that development activities remain integrated, risk-based, data-driven, compliant, and inspection-ready as programs advance through late-stage development, outbreak-response and emergency-use readiness, Process Performance Qualification (PPQ), Phase 3 clinical trials, regulatory submissions, inspections, licensure, and commercial readiness.
The Vice President establishes and oversees a scalable sponsor oversight model that defines decision rights, delegated responsibilities, quality agreements, governance forums, performance expectations, escalation pathways, and records-access requirements across internal teams and a global network of CROs, CDMOs, laboratories, consultants, and other critical partners. The role balances regulatory obligations, program timelines, organizational capacity, and mission-driven priorities.
As a member of the R&D Leadership Team, the Vice President establishes quality strategy and governance, strengthens quality culture, advises executive leadership, and builds a high-performing Quality organization. This position serves as Sabin's primary authority on GxP compliance, quality risk management, and inspection readiness.
Responsibilities- Develop and execute a roadmap for evolving the current mid-stage clinical phase-appropriate QMS into a mature QMS spanning GMP, GCP, GVP, and GLP to support advanced development activities, licensure-enabling regulatory submissions and inspections, and commercial readiness.
- Serve as a strategic advisor to executive leadership on quality, compliance, inspection readiness, and risk management.
- Embed quality culture across functions, partners, and development programs and strengthen organizational capabilities for increasing regulatory complexity.
- Own quality governance, metrics, escalation pathways, management review, and quality risk management frameworks.
- Provide senior leadership, guidance, and direction for:
- GMP quality activities supporting vaccine development, technology transfer, process validation, PPQ, commercial readiness, and lifecycle management.
- GCP quality systems supporting clinical development, including audit programs, inspection readiness, vendor oversight, and quality risk management.
- GVP quality activities supporting pharmacovigilance throughout clinical development and post-authorization, including adverse-event reporting, signal management, aggregate safety reporting, and regulatory compliance.
- GLP-related quality activities supporting nonclinical studies, including pivotal nonhuman primate studies.
- Establish and approve quality agreements and oversee risk-based qualification, auditing, monitoring, and periodic requalification of CDMOs, CROs, laboratories, depots, and other GxP partners. Ensure clear responsibilities, escalation and reporting requirements, audit and data-access rights, change and deviation notification, CAPA management, inspection support, and remediation.
- Provide quality oversight for validated GxP systems, document and data governance, records retention, data integrity, and remote-inspection capabilities. Partner with IT to support cybersecurity and business-continuity requirements for GxP systems.
- Lead inspection readiness and serve as the sponsor quality lead for FDA Bioresearch Monitoring (BIMO), Pre-Approval Inspections (PAIs), surveillance inspections, and other health authority inspections, including inspection logistics, subject-matter expert preparation, document production, response strategy, and closure of regulatory commitments.
- Direct critical investigations involving serious breaches, significant safety or data-integrity concerns, material manufacturing deviations, or systemic quality failures, ensuring timely containment, root-cause analysis, regulatory assessment, and sustainable corrective and preventive action (CAPA).
- Ensure quality systems and GxP documentation are complete, controlled, inspection-ready, and aligned with applicable FDA, EMA, ICH, WHO, and other regulatory expectations.
- Identify and escalate quality risks, drive timely mitigation, and support alignment with internal stakeholders and funding partners.
- Recruit, develop, mentor, and retain high-performing Quality professionals.
- Provide strategic oversight and contribute to required quality content for Investigational New Drug applications (INDs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), responses to health authority information requests, and other associated regulatory submissions.
- Provide Quality leadership for funding proposals and due-diligence activities.
Requirements
- Bachelor's degree in a relevant scientific, engineering, quality, or related field and at least 16 years of progressively responsible quality experience in biologics development and manufacturing; an advanced degree is preferred. Experience with vaccines, viral vectors, or similarly complex biologics is strongly preferred.
- Proven people-leadership experience and success driving organizational change, preferably in a small biotechnology and/or virtual organization. Experience serving on an R&D or executive leadership team is preferred.
- Demonstrated success developing or substantially transforming a QMS in preparation for late-stage development and licensure.
- Direct experience supporting late-stage clinical development, process validation, PPQ, PAI readiness, and BLA/MAA submissions.
- Experience leading health authority inspections and interacting with FDA and other global regulatory agencies.
- Expert knowledge of GMP, GCP, GLP, and GVP requirements; relevant ICH guidelines, including ICH E6(R3), E8, E9, Q9, and Q10; and applicable FDA, EMA, MHRA, WHO, and other global regulatory expectations.
- Demonstrated experience establishing sponsor oversight and quality governance across outsourced development and manufacturing networks, including CDMOs, CROs, and contract laboratories.
- Broad understanding of the interdependencies among nonclinical development, translational science, Phase 3 clinical operations, pharmacovigilance, biostatistics and data management, CMC, regulatory strategy, and quality, with the ability to identify and mitigate cross-functional risks to licensure.
- Demonstrated ability to lead collaboratively across technical functions, external partners, geographic regions, and matrixed teams, with strong judgment, problem-solving, and interpersonal skills.
- Experience supporting U.S. government-funded projects is preferred.
Other- Must demonstrate interest in furthering Sabin's mission.
- Subject to a criminal background investigation.
- Request for three professional references.
- Verification of education/degrees.
Work AuthorizationThis position is not eligible for visa sponsorship. Candidates must be authorized to work in the United States without employer sponsorship.
Compensation and BenefitsSabin's philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position is up to $315,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.
Sabin provides a comprehensive benefits package for eligible employees, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short-term and long-term disability options. The organization observes 10 federal holidays plus an end-of-year winter break. Additionally, Sabin offers an employer matching 401(k) plan.
Notice to Recruiters/Staffing AgenciesRecruitment vendors may not contact Sabin hiring managers, executives, or employees and must have an executed agreement on file. Unsolicited resumes do not create an agreement, and Sabin is not responsible for related fees.
Salary Description
$250,000 - $315,000
