Remote Senior Specialist, External Quality Ops

Mallinckrodt Pharmaceuticals; Bridgewater Township (NJ); Remote; USD 80,000 - 129,000; Full time

Job summary

Keenova in Bridgewater, NJ seeks a Senior Specialist, External Quality Operations to manage externally manufactured products and partner with CMOs. You will build and maintain relationships with counterparts and ensure escalation to management when needed.

Responsibilities include batch review, CMO governance, quality records, deviations, CAPAs, stability program reviews, audits, and support for quality agreements across countries; remote work with limited travel.

Qualifications

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

Responsibilities

• Batch records: review and approval for CMOs and disposition.
• CMO governance: manage third-party activities & escalation to management.
• Quality records: deviations, change controls, CAPAs; document management.
• Stability programs: protocol review and data management.
• Audits: drive audit readiness and quality assurance support.
• Quality/QMS projects: support continuous improvement across CMOs.

Skills

Quality Systems

Deviations

Change controls

Training

Supplier qualification

Document management

cGMP knowledge

GDP knowledge

ISO 13485

Education

Bachelor's Degree in scientific discipline

Job description

Keenova in Bridgewater, NJ seeks a Senior Specialist, External Quality Operations to manage externally manufactured products and partner with CMOs. You will build and maintain relationships with counterparts and ensure escalation to management when needed.

Responsibilities include batch review, CMO governance, quality records, deviations, CAPAs, stability program reviews, audits, and support for quality agreements across countries; remote work with limited travel.