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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in supplier management, quality oversight, and compliance within pharmaceutical manufacturing. Proficient in regulatory requirements, quality agreements, and process validation, with strong collaboration and problem-solving skills.
Highest-signal resume keywords
Supplier ManagementQuality OversightRegulatory ComplianceProcess ValidationLean Six Sigma
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AgreementsCGMPGDPEquipment ValidationSterile Filling ProcessesReport WritingDocumentation ReviewSupplier Performance MetricsCorrective ActionsChange Controls
Soft Skills
CollaborationProblem-SolvingDecision-MakingOwnershipIndependence
Tools & Technologies
Microsoft OfficeQualified Supplier Management System
Industry Keywords
Pharmaceutical ManufacturingRegulatory RequirementsInternational CodesQuality ControlMaterial Introduction
About the role
Key responsibilities & impact- Oversee supplier management
- Manage quality agreements and APR Quality Agreement chapter ownership
- Review documentation for new product and material introduction, including Material Packs, QC Test Specifications, BOMs, supplier qualification, and oversight
- Develop and monitor supplier performance metrics
- Participate in material review boards and quarterly reviews of key suppliers
- Maintain the approved supplier management list in the qualified Supplier Management system
- Support deviation and atypical closeout and initiate and follow up on corrective and preventive actions
- Support change controls and supplier complaints
- Provide quality oversight for new product and material introduction
- Manage external parties, including periodic re-evaluations
- Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation
- Facilitate site compliance with divisional policies, guidelines, and regulatory requirements
- Evaluate site compliance against emerging trends and initiate compliance initiatives
- Participate in Plant/Quality committees and collaborate with site functional groups
- Participate as a functional expert in cross-functional product and material introduction teams
Requirements
What you’ll need- A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment
- Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices
- Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred
- Strong report, standards, and policy writing skills
- Experience with equipment and process validation
- Familiarity with sterile filling processes and equipment
- Proficiency in Microsoft Office and job-related computer applications
- Experience or familiarity with Lean Six Sigma methodology is desired
- Good collaboration skills and ability to work effectively as part of a team
- Ability to work independently and take ownership of improvement initiatives with a moderate level of guidance
- Proven ability to drive completion of tasks
- Strong decision-making capability with accountability and responsibility
- Demonstrated problem-solving skills
Benefits
Comp & perks- Permanent contract of employment is described in the EVP
- Learning & Development in-house training
- Mentorship through constant guidance
- Career progression opportunities
- Opportunity to work at top pharmaceutical client sites
- Diverse-cultural work setting