Vice President of Quality

Rani Therapeutics•Fremont, CA

11d

About The Position

The Vice President of Quality is a key leadership role responsible for ensuring the highest quality standards, compliance, and regulatory adherence for Rani’s combination product. This role will maintain, strengthen, and mature the combination product Quality Management System (QMS) to meet regulatory expectations and support successful IND application submissions. This individual will lead the quality, and CMC functions across both pharmaceutical (drug) and medical device operations, ensuring compliance with FDA, cGMP, and global regulatory requirements, provides strategic direction for product development, and work closely with the operations and R&D teams to ensure seamless quality integration into the entire product lifecycle. This role requires an experienced subject matter expert in quality and regulatory compliance for combination products, as well as CMC leadership, with a strong background in managing FDA inspections and overseeing product development and manufacturing.

Requirements

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.
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.
Strategic Vision – Ability to develop and implement long-term quality and regulatory strategies aligned with company goals.
Technical Acumen – 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.
Leadership & Influence – Proven ability to lead teams, build a quality-driven culture, and collaborate cross-functionally.
Operational Excellence – Ability to integrate quality principles into manufacturing, product development, and regulatory compliance.
Problem-Solving & Decision-Making – Strong analytical skills to assess compliance risks and implement proactive solutions.

Nice To Haves

Direct experience with INDs and combination product approvals.
Experience in late-stage clinical development and commercial product launch.

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.
Strong emotional intelligence, ability to influence across departments and build a sustain high performing culture.