Director, CMC Supplier Management

Primary Job Responsibilities

• Identify and onboard new suppliers as needed, then build the relationships with the same while ensuring adherence to quality, timely delivery, and cost objectives.
• Develop supplier evaluation criteria, RFP content, technical due diligence materials, and vendor comparison summaries for prospective suppliers.
• Maintain supplier performance and conduct regular business and technical reviews including person-in-plant activities.
• Lead technology transfer of pharmaceutical and combination product processes from development to manufacturing including readiness, transfer package, risk management, and validation support.
• Support execution across the external supplier network including development campaigns, validation activities, manufacturing readiness, supply continuity, and resolution of manufacturing or technical issues.
• Ensure compliance with GMP, FDA, ISO, and company quality standards in all drug product and drug substance related operations.
• Drive process improvements, Lean Manufacturing initiatives, and troubleshooting for overall assembly and packaging.
• Work closely with Engineering, Quality, Regulatory Affairs, and Supply Chain teams to support product development, validations, and launches.
• Provide CMC technical input to Quality owned documentation and records including batch records, deviation reports, CAPAs, and change controls.
• Support audits and inspections by regulatory authorities and partners.

Skills and Qualifications

• Master’s degree in a Science related field, such as Pharmaceutics, Life Sciences, or related scientific field.
• Ph.D. degree in scientific discipline preferred.
• 10+ years of experience in pharmaceutical or combination product manufacturing.
• Strong knowledge of pharmaceutical regulations: FDA 21 CFR Part 820, FDA Guidance Documents, and pharmaceutical GMP standards.
• Proven ability to lead cross-functional teams and manage supplier relationships.
• PREFERRED: Experience in topical products, i.e. creams, lotions, suppositories, etc.
• PREFERRED: Experience with combination product design controls.
• FAMILIARITY: With electronic documentation systems (e.g., MES, eQMS, etc.).
• PREFERRED: Six Sigma, Lean, or PMP certification.
• ABILITY TO TRAVEL: 20-25%.

Operations

Remote (United States)