Director/Sr. Director CMC Quality Assurance

Requirements

• Support all CMC activities quality control business process build out, including but not limited to the establishment of technical operations, qualification/validation and execution analytical methods, method validations, method transfers, material specifications, stability data, expiry date extensions, and cleaning validations
• 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

Education and/or Job Experience

• 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
• 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

Qualifications

• 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