Senior Specialist, External Quality Operations

Mallinckrodt Pharmaceuticals • Bridgewater, NJ

3d • Remote

About The Position

The Senior Specialist, External Quality Operations supports Keenova’s externally manufactured pharmaceutical and biopharmaceutical products. This role builds, maintains, and manages relationships with counterparts at contract manufacturing organizations (CMOs) and cross-functional team members, and escalates issues to Manager/Director-level management and above as appropriate.

The position oversees quality activities associated with third-party manufacturing, packaging, testing, and product release. It also supports quality systems, audits, stability programs, delegated projects, and post-launch quality activities in various countries as needed. The role works in a remote, office-type environment, with limited travel as needed.

Requirements

• Bachelor’s degree in a scientific discipline is preferred.
• 5–7 years of experience working as a Quality Specialist.
• Direct experience with quality systems, including deviations, change controls, training, supplier qualification, and document management systems.

Nice To Haves

• Knowledge of cGMP requirements for pharmaceutical manufacturing.
• Knowledge of GDP and ISO 13485.

Responsibilities

• Prepare, review, and approve CMO documentation for batch production.
• Review batch records, address discrepancies, and escalate issues to management as required.
• Prepare disposition and release certification for reviewed batch records.
• Manage and oversee third-party supplier activities relating to product manufacture, packaging, and testing.
• Communicate regularly with CMOs by telephone and email to support timely manufacturing and resolve product quality issues.
• Continuously monitor products and CMO performance.
• Manage quality records, including deviations, change controls, and CAPAs.
• Monitor cold-chain transportation for qualification and routine CMO maintenance.
• Provide input into Technical Quality Agreements.
• Support post-launch quality activities in various countries as needed.
• Manage delegated projects.
• Review and approve stability program protocols and manage stability data review.
• Drive the audit-readiness program to maintain audit compliance.
• Support quality and QMS projects as required.
• Champion continuous-improvement projects identified at CMOs or within Keenova.

Benefits

• Competitive pay and benefits through a Total Rewards package.
• Eligible for a bonus in accordance with the terms of the applicable program; bonuses are awarded at the Company’s discretion.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior