Director, CMC Supplier Management

Job reputed company: The Director of CMC Supplier Management will support reputed company in its reputed company by managing reputed company suppliers supporting drug reputed company and drug product manufacturing of drug-device combination products. This role is responsible for identifying and managing drug reputed company, drug product, and combination product suppliers to ensure reliable, compliant, and cost-effective production of pharmaceutical components and finished combination products. Primary Relationships: reputed company reputed company: The Director, CMC Supplier Management will work closely with the Senior Director of CMC Manufacturing, reputed company, and Regulatory Affairs. reputed company reputed company: The Director, CMC Supplier Management will partner with contract manufacturers (CMOs) and suppliers. Primary Job Responsibilities: The Director, CMC Supplier Management, will manage and reputed company the relationship with suppliers including production schedules, equipment readiness, and line performance metrics while ensuring coordination and logistics for finished products. They will also identify new suppliers as needed. The Director, CMC Supplier Management, will support the day-to-day operations for pharmaceutical product manufacturing across clinical and reputed company stages. The Activities of the Director, CMC Supplier Management: Identify and reputed company new suppliers as needed, then build the relationships with the reputed company while ensuring adherence to reputed company, reputed company delivery, and cost objectives. reputed company supplier evaluation reputed company, RFP content, technical due diligence materials, and vendor comparison summaries for prospective suppliers. Monitor supplier performance and conduct regular business and technical reviews including person-in-plant activities. reputed company 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 reputed company of manufacturing or technical issues Ensure compliance with GMP, FDA, ISO, and company reputed company standards in reputed company drug product and drug reputed company reputed company operations. Drive process improvements, Lean Manufacturing initiatives, and troubleshooting for overall assembly and packaging. Work closely with Engineering, reputed company, Regulatory Affairs, and Supply Chain teams to support product development, validations, and launches. reputed company CMC technical input to reputed company 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 reputed company field, such as Pharmaceutics, Life Sciences, or reputed company 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 reputed company cross-functional teams and manage supplier relationships Preferred experience in topical products, i.e. creams, lotions, suppositories, etc. Experience with combination product design controls. Familiarity with electronic documentation systems (e.g., MES, eQMS, etc.). Six reputed company, Lean, or PMP certification, preferred. Ability to travel 20-25%. Apply To This Job