Senior External Quality Ops Lead (Remote)

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

Benefits offered by this job

Total Rewards package

Job summary

Keenova in Bridgewater, NJ is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products and build strong relationships with CMOs to ensure quality and compliance across sites.

You will oversee batch review, CMO documentation, deviations, CAPAs, and audits, with remote/office work and limited travel. Requires 5–7 years in quality systems, cGMP, and document management.

Qualifications

• Bachelor’s Degree in scientific discipline.
• 5–7 years’ experience in quality operations.
• Experience with quality systems and document control.

Responsibilities

• Batch review and disposition.
• Prepare, review and approve CMO documentation.
• Review batch records and address discrepancies.
• Oversee deviations, CAPA, change controls.

Skills

Quality Systems

cGMP knowledge

CMO management

Documentation control

Attention to detail

Education

Bachelor’s Degree in scientific discipline

Job description

Keenova in Bridgewater, NJ is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products and build strong relationships with CMOs to ensure quality and compliance across sites.

You will oversee batch review, CMO documentation, deviations, CAPAs, and audits, with remote/office work and limited travel. Requires 5–7 years in quality systems, cGMP, and document management.