Remote Senior Specialist, External Quality Ops

Mallinckrodt; Bridgewater (MA); Remoto; USD 80.000 - 129.000; Tempo pieno

Descrizione del lavoro

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products and collaborate with CMOs. You will build relationships with counterparts, escalate to senior management, and drive continuous improvement in quality systems.

The role involves batch review, document control, and ensuring compliance with cGMP, GDP, and ISO 13485 across multiple countries. A remote/office setup and limited travel may apply.

Competenze

• Bachelor's degree in a scientific discipline with 5–7 years of quality operations experience.
• Direct experience with Quality Systems (deviations, change controls, training, supplier qualification and document management)
• Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485.

Mansioni

• Batch review preparation, review and approval of CMO documentation for batch production.
• Review batch records, addressing discrepancies and escalating where required to management.
• Preparation of disposition and release certification for reviewed batch records.
• CMO Governance Management and oversight of third‑party supplier activities relating to the manufacture, packaging and testing of product.
• Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product.
• Continuous monitoring of product and performance from CMOs.
• Quality Support and Deputation Quality record management; deviations, change controls, CAPAs
• Audits Drive the audit readiness program to always ensure audit compliance

Conoscenze

cGMP knowledge

GDP ISO 13485 knowledge

Formazione

Bachelor's Degree in scientific discipline

Descrizione del lavoro

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products and collaborate with CMOs. You will build relationships with counterparts, escalate to senior management, and drive continuous improvement in quality systems.

The role involves batch review, document control, and ensuring compliance with cGMP, GDP, and ISO 13485 across multiple countries. A remote/office setup and limited travel may apply.