Manager, External Quality

Mallinckrodt Pharmaceuticals

. Provide complete quality oversight for assigned contract manufacturing organizations (CMOs), product lines, and Quality staff .

Posted 11/12/2026full-timeDublin • IrelandMid-LevelSenior💰 €80,000 - €108,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in cGMP systems, quality oversight, and regulatory compliance within the pharmaceutical manufacturing sector. Proven ability to lead cross-functional projects, manage relationships with contract manufacturing organizations, and drive continuous quality improvement initiatives.

Highest-signal resume keywords

CgmP SystemsQuality OversightRegulatory AffairsProject ManagementChange Management

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality EngineeringProduct ReleaseInvestigationsValidationStatistical Techniques

Soft Skills

LeadershipConflict ResolutionNegotiationCommunicationFacilitation

Tools & Technologies

WordAccessExcelPowerPoint

Industry Keywords

Pharmaceutical ManufacturingCGMP ComplianceFDA InspectionsCAPAContinuous Improvement

About the role

Key responsibilities & impact

Provide complete quality oversight for assigned contract manufacturing organizations (CMOs), product lines, and Quality staff
Exercise signature authority and escalate high-risk issues to management
Act as decision maker for compliance issues and lead cross-site or cross-divisional projects and issue resolutions
Build and manage relationships with CMO counterparts and cross-functional Keenova team members
Coordinate compliance activities and projects with CMO and Keenova groups
Ensure compliance with cGMP, regulatory, and internal requirements for manufacturing, testing, and distribution
Oversee change management, investigations, product release, annual product review, management review, master documents, validation, stability, and CAPA
Provide quality, compliance, and business strategy for major initiatives
Assign project resources, organize work, and guide direct reports
Support CMO audits and participate in audit teams
Develop and execute project plans and timelines
Champion continuous improvement and identify safety and waste minimization opportunities
Create, approve, and implement quality system procedures
Plan and follow up on CMO site visits
Ensure MRB and FAR decisions are made and executed, including follow-up investigations
Support FDA and other regulatory body investigations and inquiries
Design and monitor KPIs and staff goals
Lead QA staff through goal setting, prioritization, issue resolution, and personnel development
Provide QA recommendations on products, systems, and issues affected by regulatory or cGMP requirements
Report to the Director, External Quality Operations

Requirements

What you’ll need

Minimum BS in Chemistry, Chemical Engineering, related science or equivalent combination of Education, Experience and Competencies
Minimum 5–7 years’ experience in a quality engineer or equivalent role
Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, including experience in a manufacturing setting
Experience with application of cGMP to manufacturing and testing
Experience with product release and investigations
Experience with change management and CAPA
Experience with FDA inspections and Regulatory Affairs
Experience with validation
Experience with statistical techniques
Proficiency with Word, Access, Excel, and PowerPoint
Understanding of the pharmaceutical industry and its unique business and social responsibilities
Excellent facilitation and presentation skills
Excellent technical and compliance-based writing skills
Ability to manage projects involving multiple functional groups without direct reporting authority
Strong communication, conflict resolution, negotiation, and leadership skills
Ability to identify and drive continuous quality improvement
Mature judgment in problem-solving situations
Willingness and ability to travel 20% or more domestically and internationally

Benefits

Comp & perks

Competitive pay and benefits
Bonus eligibility in accordance with the applicable program
Remote/hybrid working arrangement
Opportunities for professional development and personnel development
Total Rewards package