Vor Bio

Role Description Join Us in Tackling Autoimmune Disease at Its Root. At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Key Responsibilities - GMP Quality Oversight: Point of contact for GMP Quality Operations function for clinical manufacturing, distribution, validation and commercialization activities. Support tech transfer as applicable. Ensure all activities comply with relevant regulatory guidelines (FDA, EMA, ICH, etc.) and Quality Agreements. - Regulatory Compliance: Support regulatory inspections and audits (FDA, EMA, etc.) as assigned. - Supplier & CMO Management: Provide quality oversight of external manufacturers, contract manufacturing organizations (CMOs), and suppliers to ensure compliance with GMP standards. - Quality Systems and Compliance: Provide oversight on investigations related to deviations and product quality issues, ensuring timely resolution, root cause analysis and CAPA implementation. Point of contact for 3rd party supplier & CMO quality events. Responsible for inputting quality documents into the eQMS. - Inspection Readiness: Support functional groups to perform identified inspection readiness activities and provide oversight of vendor inspection readiness activities. - Documentation Management: Author, review and approval of GMP documentation, including batch records, release specifications, QC data, protocols, validation reports, etc. - Risk Management: Identify and mitigate quality risks within clinical development and pre-commercialization activities. - Cross-functional Collaboration: Partner with CMC, Supply Chain, Commercial and Regulatory Affairs teams to ensure quality compliance throughout the product lifecycle from clinical trials to commercial manufacturing. Qualifications - Education: Bachelor's degree in Life Sciences, Engineering, or a related field. - Experience: Minimum 8 years of experience in quality operations, quality assurance, or GMP manufacturing within the biotechnology or pharmaceutical industry. Experience with Phase 3 clinical trials and the transition to commercialization is highly preferred. - Skills & Competencies: - Expertise in GMP, regulatory requirements, and industry best practices (FDA, EMA, ICH). - Ability to collaborate with cross-functional teams and complex initiatives. - Excellent knowledge of quality systems, documentation, and compliance management. - Exceptional problem-solving, troubleshooting, and analytical skills. - Strong communication and presentation skills, both written and verbal. - Ability to work effectively in a remote, fast-paced, and evolving environment. Requirements - The salary range for the Senior Manager GMP Quality is expected to be between $160,000 and $175,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location. - The salary range for the Associate Director GMP Quality is expected to be between $175,000 and $200,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location. Benefits - Comprehensive health coverage - Flexible paid time off - Generous parental leave - Competitive 401(k) - Education assistance - Wellness resources - Financial security Company Description At Vor, we support our team with robust benefits. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information.

Role Description The Director, Regulatory Strategy provides global regulatory leadership and strategic direction across one or more development programs in immunology. This role is accountable for shaping and executing regulatory strategies that enable timely product development, approval, and lifecycle management while ensuring compliance with global regulatory requirements. The Director acts as a strategic partner to R&D, Clinical, Quality, CMC, Commercial, and represents the organization in high-level interactions with global regulatory authorities. Key Responsibilities - Regulatory Strategy & Leadership - Develop and lead global, integrated regulatory strategies for investigational and marketed products across the product lifecycle, including late stage development. - Provide strategic input on development plans, target product profiles, labeling, indications, and sequencing of regulatory submissions. - Anticipate and mitigate regulatory risks; proactively identify opportunities for regulatory flexibility, expedited programs, and innovative pathways. - Serve as a key regulatory advisor to senior leadership and cross-functional governance bodies. - Regulatory Agency Engagement - Lead and/or oversee global regulatory authority interactions, including IND/CTA meetings, End-of-Phase meetings, scientific advice, and other milestone interactions. - Develop briefing documents, talking points, and negotiation strategies aligned with program objectives. - Interpret and communicate regulatory feedback to cross-functional teams and translate it into actionable plans. - Submissions & Execution Oversight - Provide strategic oversight for major regulatory filings (e.g., INDs/CTAs, NDAs/BLAs/MAAs, supplements, variations). - Ensure submission strategies are aligned with global regulatory expectations and business priorities. - Review and approve regulatory strategy documents, submission plans, and key content from a strategic perspective. - Cross-Functional Collaboration - Partner closely with Clinical Development, Biostatistics, CMC, Nonclinical, Pharmacovigilance, Quality, and Commercial teams to align regulatory strategy with development and commercialization goals. - Influence program decision-making by integrating regulatory considerations early and consistently. - Support due diligence, licensing, and business development activities from a regulatory standpoint. - People & Matrix Leadership - Mentor and develop regulatory strategists and/or regulatory leads; provide strategic oversight within a matrixed team environment. - Contribute to the evolution of regulatory strategy capabilities, processes, and best practices within the organization. - Promote a culture of scientific rigor, regulatory excellence, and proactive risk management. - Policy & Intelligence - Monitor and interpret evolving global regulatory trends, guidance, and policy changes relevant to assigned programs or therapeutic areas. - Assess the impact of regulatory intelligence on development and lifecycle strategy. Qualifications - Bachelor’s degree required; Relevant advanced degree preferred (PhD, PharmD, MD, MSc, or equivalent in life sciences). - 7+ years of progressively responsible experience in Regulatory Affairs within the pharmaceutical industry. - Demonstrated experience leading global regulatory strategies for development programs and/or major regulatory submissions. - Proven success in direct interactions with global regulatory authorities. - Experience working in matrixed, cross-functional development teams. - Remote role; occasional travel required for regulatory meetings and internal governance forums. Skills & Competencies - Strong strategic thinking with the ability to balance regulatory risk, scientific evidence, and business objectives. - Deep understanding of global regulatory frameworks and product development. - Excellent leadership, influence, and communication skills, including the ability to engage senior executives. - Ability to navigate ambiguity and drive alignment across diverse stakeholders. - Strong written and verbal communication skills. Preferred Qualifications - Experience in a specific therapeutic area is a plus (e.g., rare disease, immunology, neurology). - Experience with accelerated pathways (e.g., Fast Track, Breakthrough Therapy). - Experience supporting global commercialization and post-approval lifecycle activities. Benefits - Comprehensive health coverage. - Flexible paid time off. - Generous parental leave. - Competitive 401(k). - Education assistance. - Wellness resources. - Financial security. Company Description At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.