Director, CMC Supplier Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and manage supplier relationships, including coordinating production schedules, ensuring equipment readiness, and tracking line performance metrics for finished products.

• Identify and onboard new suppliers as necessary, fostering strong relationships while ensuring compliance with quality standards, timely delivery, and cost-effectiveness.

• Create supplier evaluation criteria, develop RFP content, prepare technical due diligence materials, and compile vendor comparison summaries for potential suppliers.

• Track supplier performance and conduct regular business and technical reviews, including on-site activities.

• Lead the technology transfer of pharmaceutical and combination product processes from development to manufacturing, covering aspects such as readiness, transfer packages, risk management, and validation support.

• Support execution across the external supplier network, including development campaigns, validation activities, manufacturing readiness, supply continuity, and troubleshooting of manufacturing or technical challenges.

• Ensure adherence to GMP, FDA, ISO, and company quality standards in all operations related to drug products and drug substances.

• Champion process enhancements, Lean Manufacturing initiatives, and troubleshooting to improve overall assembly and packaging processes.

• Collaborate closely with Engineering, Quality, Regulatory Affairs, and Supply Chain teams to facilitate product development, validations, and launches.

• Provide CMC technical input for Quality-owned documentation and records, such as batch records, deviation reports, CAPAs, and change controls.

• Assist during audits and inspections conducted by regulatory authorities and partners.

⛳️ Requirements

• Master’s degree in a Science-related field, such as Pharmaceutics, Life Sciences, or a related scientific discipline.

• Ph.D. in a scientific field is preferred.

• A minimum of 10 years of experience in pharmaceutical or combination product manufacturing.

• In-depth knowledge of pharmaceutical regulations, including FDA 21 CFR Part 820, FDA Guidance Documents, and GMP standards.

• Demonstrated ability to lead cross-functional teams and manage supplier relationships effectively.

• Experience with topical products, such as creams, lotions, suppositories, etc., is preferred.

• Familiarity with combination product design controls.

• Proficiency with electronic documentation systems (e.g., MES, eQMS, etc.).

• Six Sigma, Lean, or PMP certification is preferred.

• Willingness to travel 20-25% of the time.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development