Senior Specialist, External Quality Operations

Mallinckrodt Pharmaceuticals

. Support externally manufactured pharmaceutical and biopharmaceutical products .

Posted 10/12/2026full-timeRemote • United StatesSenior💰 $80,000 - $129,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing quality systems and compliance within pharmaceutical manufacturing, including cGMP, GDP, and ISO 13485 standards. Proven ability to build relationships with CMO counterparts and oversee third-party manufacturing and quality activities.

Highest-signal resume keywords

Quality Systems ManagementCGMP KnowledgeDeviation ManagementChange Control ManagementSupplier Qualification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Batch-Production Documentation ReviewQuality Record ManagementCAPA ManagementStability Program Protocol ReviewData Management

Soft Skills

Relationship ManagementCommunicationProblem-Solving

Tools & Technologies

Document Management SystemsQuality Management Systems

Industry Keywords

Pharmaceutical ManufacturingBiopharmaceutical ProductsCold-Chain TransportationTechnical Quality AgreementsAudit Readiness

About the role

Key responsibilities & impact

Support externally manufactured pharmaceutical and biopharmaceutical products
Build, maintain and manage relationships with CMO counterparts and cross-functional team members
Review and approve CMO batch-production documentation
Review batch records, address discrepancies and escalate issues to management
Prepare disposition and release certification for reviewed batch records
Manage CMO governance and oversee third-party manufacturing, packaging and testing activities
Communicate with CMOs to support timely manufacture and resolve quality issues
Monitor product and CMO performance
Manage quality records, including deviations, change controls and CAPAs
Monitor cold-chain transportation qualification and routine operations
Provide input into Technical Quality Agreements
Support post-launch quality activities in various countries
Manage delegated projects
Review and approve stability program protocols
Review and manage data
Drive audit readiness and compliance
Champion continuous improvement projects at CMOs and within Keenova

Requirements

What you’ll need

Bachelor’s Degree in scientific discipline, preferred
5–7 years’ experience working as a Quality Specialist
Direct experience working with Quality Systems, including deviations, change controls, training, supplier qualification and document management systems
Knowledge of cGMP requirements for pharmaceutical manufacturing
Knowledge of GDP and ISO 13485
Ability to work in a remote, office-type environment
Limited travel as needed

Benefits

Comp & perks

Competitive pay and benefits
Bonus eligibility in accordance with the applicable program
Remote work arrangement
Limited travel as needed