Remote Senior Specialist, External Quality Operations

Mallinckrodt Pharmaceuticals; United States; Remote; USD 80,000 - 129,000; Full time

Job summary

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products, coordinating with CMOs and cross-functional teams. You will oversee batch documentation, deviations, CAPAs and post-launch quality activities, ensuring compliance across markets.

The role requires 5+ years in quality operations with knowledge of cGMP, GDP and ISO13485, and the ability to manage audits and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in scientific discipline; +5-7 years’ experience in Quality
• Experience with Quality Systems (deviations, change controls, training, supplier qualification and document management)
• Knowledge of cGMP requirements for pharma manufacturing; GDP and ISO 13485 familiarity

Responsibilities

• Batch Review: prepare, review and approve CMO documentation for batch production
• Review batch records; address discrepancies and escalate to management
• Prepare disposition and release certificates for reviewed batches
• CMO Governance: oversee third-party supplier activities for manufacturing, packaging and testing
• Maintain regular communication with CMOs to ensure timely manufacture and resolution of quality issues
• Monitor product and performance from CMOs
• Quality Support and Deputation: manage quality records; deviations, change controls, CAPAs
• Monitor cold-chain transportation; qualify and routine
• CMO Maintenance; input into Technical Quality Agreements
• Post-launch support for quality activities in various countries
• Manage delegated projects
• Stability Program: protocol review and data management
• Audits: drive audit readiness and compliance
• Quality/QMS Projects: champion continuous improvement at CMOs or Keenova

Skills

Quality Systems

cGMP knowledge

GDP ISO13485

Supplier qualification

Education

Bachelor’s Degree in science

Job description

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products, coordinating with CMOs and cross-functional teams. You will oversee batch documentation, deviations, CAPAs and post-launch quality activities, ensuring compliance across markets.

The role requires 5+ years in quality operations with knowledge of cGMP, GDP and ISO13485, and the ability to manage audits and continuous improvement initiatives.