Rani Therapeutics · 1 month ago
Vice President of Quality
Fremont, CA
Full-time
Onsite
Director/Executive
$325K/yr - $363K/yr
15+ years expRani Therapeutics is seeking a Vice President of Quality to lead the quality and regulatory compliance for their combination product. This role entails establishing a robust Quality Management System, managing compliance functions, and providing strategic oversight for CMC activities while collaborating with various teams to ensure quality integration throughout the product lifecycle.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Establish and maintain a robust Quality Management System (QMS) to ensure compliance with GxP and FDA regulations (21 CFR part 4, 820, 210 & 211), ICH guidelines, ISO 13485 standard, and other regulatory body regulations and guidelines
Lead and manage quality assurance (QA), quality control (QC), and compliance functions for combination product operations
Lead preparation for and management of regulatory inspections, audits, and assessments, ensuring compliance with global regulatory guidelines such as the FDA, EMA, and ICH
Lead and support Quality due diligences audit from potential and existing partners
Provide strategic oversight for CMC activities, ensuring robust drug and device development, lifecycle management, and post-approval planning
Develop a phase-appropriate CMC strategy
Lead quality strategy for combination product development, ensuring alignment with regulatory expectations and best practices
Partner with R&D, Operations and Clinical to drive quality into product development from early-stage development through commercialization
Collaborate closely with manufacturing teams to ensure quality integration throughout production processes
Guide and support technology transfer, process validation, and scale-up efforts, ensuring compliance with cGMP and regulatory requirements
Implement quality risk management strategies to mitigate compliance risks and drive continuous improvement
Guide Supply chain group ensuring external partners meet quality and regulatory standards
Build and develop a high-performing quality and regulatory teams, including (QA, QC, and CMC)
Mentor and coach quality leaders and cross-functional teams to enhance technical expertise and regulatory knowledge
Foster a collaborative and proactive quality culture that integrates seamlessly with product development and manufacturing operations
Qualification
Required
Advanced degree (PhD, MS, or MBA) in Life Sciences, Engineering, Regulatory Affairs, or related field
15+ years of Quality leadership experience in the biopharmaceutical and/or combination product industry, with at least 5 years in an executive or senior leadership role
Direct experience with INDs and combination product approvals
Experience in late-stage clinical development and commercial product launch
Proven expertise in FDA regulations and supporting IND filings, cGMP and regulatory compliance for combination products
Strong CMC experience, including leadership of drug and device development, validation, and manufacturing processes
Deep understanding of ISO 13485, 21 CFR Part 820 (devices), 21 CFR Part 4 (combination products), 21 CFR Part 210/211 (pharmaceuticals), and ICH guidelines
Strong leadership skills with the ability to influence and drive cross-functional collaboration in a fast-paced environment
Ability to develop and implement long-term quality and regulatory strategies aligned with company goals
Strong CMC knowledge to support drug/device development, manufacturing, and validation
Deep regulatory compliance understanding for combination products and ability to interface effectively with global health authorities
Proven ability to lead teams, build a quality-driven culture, and collaborate cross-functionally
Ability to integrate quality principles into manufacturing, product development, and regulatory compliance
Strong analytical skills to assess compliance risks and implement proactive solutions
Company
Rani Therapeutics
Rani is a clinical-stage biotherapeutics company that enables the development of orally administered biologics to improve patient outcomes.
51-200 employees
H1B Sponsorship
Rani Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (4)
2023 (10)
2022 (3)
Funding
Current Stage
Public CompanyTotal Funding
$329.8MKey Investors
Samsara BioCapitalGoogle VenturesIncube Ventures
2025-10-17Post Ipo Equity· $60.3M
2025-07-15Post Ipo Equity· $3M
2024-07-22Post Ipo Equity· $10M
Leadership Team
Talat Imran
Chief Executive Officer
Kate Flavin McKinley
Chief Business Officer
Recent News
2026-01-09
Company data provided by crunchbase