Senior External Quality Operations Specialist (Remote)

Mallinckrodt Pharmaceuticals; Malvern (Chester County); Remote; USD 80,000 - 129,000; Full time

Job summary

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products, coordinate with CMOs, and escalate issues to leadership. The role emphasizes batch review, governance, and continuous improvement within a global quality framework.

The position requires direct experience with quality systems including deviations, change controls, and supplier qualification. Knowledge of cGMP, GDP, and ISO 13485 is preferred. Remote work with limited travel is possible.

Qualifications

• Direct experience with Quality Systems (deviations, change controls, training, supplier qualification and document management systems).
• Knowledge of cGMP requirements for pharmaceutical manufacturing.
• Knowledge of GDP and ISO 13485.

Responsibilities

• Batch Review: prepare, review and approve CMO documentation; review batch records and escalate issues; prepare disposition and release certificates.
• CMO Governance: manage third-party supplier activities; maintain regular communication with CMOs; monitor product performance.
• Quality Support and Deputation: manage quality records; monitor cold-chain transport; input into Technical Quality Agreements; post-launch quality activities; manage delegated projects.
• Stability Program: protocol review and data management.
• Audits: drive audit readiness and compliance.
• Quality/QMS Projects: support continuous improvement at CMOs or Keenova.

Skills

Quality Systems knowledge

cGMP knowledge

GDP/ISO 13485 knowledge

Education

Bachelor's Degree in scientific discipline

Job description

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products, coordinate with CMOs, and escalate issues to leadership. The role emphasizes batch review, governance, and continuous improvement within a global quality framework.

The position requires direct experience with quality systems including deviations, change controls, and supplier qualification. Knowledge of cGMP, GDP, and ISO 13485 is preferred. Remote work with limited travel is possible.