Director/Sr. Director CMC & Quality Assurance

Rani Therapeutics•Fremont, CA

About The Position

The Director/ Senior Director of CMC QA will provide quality oversight/leadership for the CMC activities associated with Drug Products. This position provides technical, CMC, operational, and strategic leadership in the development and implementation of all quality control and related activities. The ideal candidate will establish phase-appropriate critical quality attribute determination for drug release testing, support stability programs, and will work across disciplines in order to deliver a clear strategy to maintain and improve product quality and process robustness. A solid understanding of the industry’s complex regulatory requirements and a commitment to ensuring quality is essential. The role will require full collaboration with the entire quality department, analytical development, manufacturing operations, and regulatory affairs teams.

Requirements

PhD in a scientific discipline with 7+ years or MS/BS degree with 10+ years of experience in Analytical Development/Quality Control in a GxP pharmaceutical environment
A proven track record of implementing phase-appropriate quality control strategies, method validation and specification development
Working knowledge of cGMP requirements, including 21 CFR 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, EU, PIC/S, ISO), as well as pharmacopeia standards
Direct experience in managing analytical development/QC activities at CROs and CDMOs
CMC-specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics and/or combination products
Expert knowledge of cGMP compliance regulations and industry practices for US/EU
Proficient in risk assessment and root cause analysis tools
Demonstrate keen understanding of domestic and internal quality systems regulations to adopt best-in-class systems/processes and drive continuous improvement initiatives
Provide coaching and mentoring to CMC and cross-functional team members, raising overall combination‑product CMC capability
High emotional intelligence and ability to collaborate productively across various functions
Strong verbal and written communication skills
Ability to effectively present to broad groups with varying levels of CMC expertise to effectively communicate progress, needs and challenges
Must be able to work in a fast-paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation
Excellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individuals and teams across the organization
Collaborative, goal-oriented, and able to work in a fast-paced environment
Must be strategic as well as hands-on
Attention to detail and organizational skills
Must demonstrate ability to work independently, make effective decisions

Nice To Haves

Previous experience with combination products preferred

Responsibilities

Support all CMC activities quality control business process build out, including but not limited to the establishment of technical operations, qualification/validation and execution of analytical methods, method validations, method transfers, material specifications, stability data, expiry date extensions, and cleaning validations
Serve as the CMC representative in health authority and notified‑body meetings, inspections, and responses for combination product topics.
Proactively identify regulatory risks for drug–device configurations (e.g., bridging, platform devices, design control) and drive mitigation strategies
Oversee integration of drug, device, and primary container data (engineering, usability, biocompatibility, extractables/leachables, connectivity) into the CMC strategy
Ensure activities and deliverables are in compliance with applicable FDA, EMA and GxP regulations, ICH guidelines, Rani procedures, and industry best practices
Support internal and external GMP manufacturing along with oversight of GMP sample handling, testing, QC stability program, QC release and stability data analyses, OOE/OOS investigations, deviations, CAPAs and support certificates of analysis generation for drug products
Foster a quality and continuous improvement mindset to ensure that all QC deliverables are cGMP compliant in a phase-appropriate fashion to support clinical and commercial programs
Provide quality oversight related to GMP activities, including approval of method validation, specifications, release testing for raw materials, intermediates, excipients, APIs, and drug products
Oversee work at external contract labs/vendor analytical labs, including method development, qualification, transfer, and validation
Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality risks, including application of controls supporting risk-based continued process verification and monitoring of lifecycle product quality
Manage supplier qualification and requalification activities for CROs and CDMOs
Ensure robust processes are implemented for management of clinical and commercial product and process lifecycle quality (e.g., control strategy, technology transfer, process validation lifecycle, quality monitoring)
Support continuous collaboration with analytical development, technical operations, manufacturing, QA, regulatory affairs, clinical development, and program management, as well as external vendors (CROs and CDMOs)
Close engagement with analytical development to build a sustainable GMP quality control platform to support commercial and growing portfolio of clinical development programs
Support quality review of CMC sections of regulatory filings and participate in inspection readiness efforts
Serve as CMC subject matter expert for external due diligence efforts, regulatory interactions with authorities, and current pharmaceutical partners to accurately represent Rani’s CMC capabilities and instill confidence in strategic plans.