Director/Sr. Director, CMC Quality Control

The Director/Sr. Director of CMC Quality Control will provide quality oversight/support for the CMC activities associated with Drug-Device Combination Products. This position provides hands-on 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 biologics, 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 for drugs, aseptic manufacturing and combination products and a commitment to ensuring quality, is essential. The role will require full collaboration with analytical development, manufacturing operations and regulatory affairs teams. 

Requirements

• Develop and implement QC policies and procedures that are in line with industry standards and regulations for GMP sample management, product release and stability testing, data integrity, OOS investigations, deviations, CAPAs.
• Develop and implement test methods for testing raw materials, intermediate products and finished products to ensure that they meet the required quality standards.
• Build QC organization by hiring, developing and retaining a highly performing QC team including providing technical training to the QC personnel.
• Ensure activities and deliverables are in compliance with applicable FDA, EMA and GxP regulations, ICH guidelines, Rani procedures, and industry best practices.
• Implement aseptic process contamination control plan, testing strategy and monitoring program for GMP manufacturing along with oversight of GMP sample handling, environmental monitoring, cleaning validation and disinfection efficacy evaluation.
• 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.
• Develop and execute method validation protocol, reports, specifications for 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.
• Participate in 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 manufacturing, 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.

Education and/or Job Experience

• PhD in a scientific discipline with 7+ years or MS/BS degree with 10+ years of Pharma industry experience in Analytical Development/Microbiology in a GxP pharmaceutical environment.
• A proven track record of implementing phase appropriate quality control testing 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.
• Previous experience with combination products preferred.
• 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.

Skills and Specifications

• 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 individual and teams across the organization.
• Collaborative, goal-oriented, and an ability 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.

Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.

Our organization's commitment to Diversity, Equity, and Inclusion is key to making us a better team - one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we're committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.