Quality Assurance Regulatory Compliance Specialist

PCI Pharma Services

. Establish and manage third-party and clinical supply chains within PCI’s clinical regulatory compliance function .

Posted 11/11/2026full-timeStamullen • IrelandMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates expertise in managing clinical supply chains and regulatory compliance within the pharmaceutical industry, with a strong focus on Quality Systems, supplier audits, and adherence to EU regulatory requirements. Proven ability to communicate effectively with clients and stakeholders while ensuring compliance with GMP regulations.

Highest-signal resume keywords

Clinical Supply Chain ManagementRegulatory Compliance ExpertiseQuality Systems DevelopmentSupplier Audits ManagementGMP Regulations Application

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

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

Hard Skills

Product Specification Files CreationQP Release SupportDeviation ManagementCorrective Action RequestsNon-Conformance ReportingSOP GenerationMasterControl ProficiencyRegulatory Filings ExperienceChange Control ReviewRisk Register Maintenance

Soft Skills

Effective CommunicationGoal SettingClient-Facing ExperienceProject ManagementProcess Improvement Identification

Industry Keywords

Pharmaceutical IndustryBiological IndustryEU Regulatory RequirementsQuality Technical AgreementsVendor Performance ManagementManufacturing and Importation LicenceThird-Party QP ReviewCompliance FrameworksSupplier QualificationAd Hoc Project Management

About the role

Key responsibilities & impact

Establish and manage third-party and clinical supply chains within PCI’s clinical regulatory compliance function
Support right-first-time QP release
Work with clients and internal stakeholders on regulatory change across multi-site supply chains
Create and maintain Product Specification Files for clinical supply chains where QP certification is performed
Develop and manage Quality Systems and Compliance frameworks supporting clinical supply-chain maintenance and release
Maintain the Approved CMO list and Supply Chain / CMO Risk Register
Manage supplier audits, Quality Technical Agreements, supplier qualification, and vendor performance management
Prepare and maintain approved product and supplier lists
Prepare QP declarations for third-party QP review and approval
Prepare and review Product Quality Reviews supporting third-party QP release
Review and track third-party change controls with product quality or regulatory impact
Support management of the Manufacturing and Importation Licence and associated variations
Raise Deviations, Corrective Action Requests, and Non-Conformance reports
Generate SOPs, Forms, Job Aids, and Work Instructions in MasterControl
Identify process and procedure improvement opportunities
Undertake specific or ad hoc projects as required

Requirements

What you’ll need

Bachelor's degree in a scientific, technical or engineering discipline, or associate degree / diploma / certificate
Relevant experience may be considered in lieu of formal educational requirements
Minimum 5 years’ experience within the pharmaceutical and/or biological industry
At least 2 years in a regulatory- or compliance-focused role
Strong working knowledge of EU regulatory requirements applicable to pharmaceuticals
Ability to apply GMP regulations and international guidelines
Ability to set clear goals, communicate them effectively, and ensure progress to completion against predefined targets
Demonstrated client-facing experience
Desirable: experience auditing external suppliers, contractors and vendors
Desirable: experience with regulatory filings and variations

Benefits

Comp & perks

Equal Employment Opportunity and Affirmative Action employer
Inclusive workplace committed to fairness, respect, and equal opportunity
Opportunities to belong and grow within the PCI community