Director, CMC Supplier Management

Cristcot

Director of CMC Supplier Management overseeing and managing supplier relationships for drug manufacturing. Focus on quality, compliance, and operational efficiency in pharmaceutical production.

Posted 6/20/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

supplier managementproduction schedulingvendor evaluationtechnology transferrisk managementprocess improvementLean Manufacturingpharmaceutical manufacturingcombination product designGMP compliance

Soft Skills

relationship managementcross-functional team leadershipcommunicationtroubleshootingorganizational skills

Tools & Technologies

MESeQMSregulatory documentationbatch recordsCAPAschange controls

Certifications & Qualifications

Six SigmaLeanPMP

Industry Keywords

FDA regulationsISO standardspharmaceutical GMPtopical productsdrug product operations

Tech Stack

Tools & technologies

AssemblyPMP

About the role

Key responsibilities & impact

Manage and oversee the relationship with suppliers including production schedules, equipment readiness, and line performance metrics while ensuring coordination and logistics for finished products
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
Monitor 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

Requirements

What you’ll need

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.
Experience with combination product design controls
Familiarity with electronic documentation systems (e.g., MES, eQMS, etc.)
Six Sigma, Lean, or PMP certification preferred
Ability to travel 20-25%.

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development