Quality Assurance Manager / QP

ACCPRO; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

ACCPRO, a leading pharmaceutical manufacturer in Dublin, seeks an experienced QA Manager / Qualified Person (QP) to lead Quality Assurance and Quality Control at its onsite facility.

This leadership role ensures full compliance with EU GMP, HPRA requirements and pharmaceutical quality standards, while driving a culture of quality excellence across the organisation. The incumbent will act as the site QP and oversee QA/QC operations, supporting regulatory inspections, CAPAs and product release.

Qualifications

• Minimum 3 years operating on an HPRA licence.
• 5+ years' experience within GMP-regulated pharmaceutical manufacturing.
• Strong knowledge of EU GMP, HPRA regulations, quality systems and compliance requirements.

Responsibilities

• Act as the site Qualified Person (QP) and named Quality Controller.
• Lead the QA and QC teams (approx. 5 direct reports), coaching and performance management.
• Ensure ongoing compliance with GMP, HPRA, Product Licence and regulatory requirements.

Skills

QA/QC Leadership

QP Experience

GMP Compliance

Regulatory Knowledge HPRA/EU GMP

Stakeholder Management

Quality Systems (QMS)

Product Release & Deviation Handling

Education

Degree in Pharmacy / Chemistry / Pharmaceutical Sciences / Biology

Job description

Location: South Dublin - full time onsite

Duration: Full time permanent

A leading pharmaceutical manufacturer is seeking an experienced QA Manager / Qualified Person (QP) to lead Quality Assurance and Quality Control operations at its Dublin site.

This is a leadership role responsible for ensuring full compliance with EU GMP, HPRA requirements and pharmaceutical quality standards, while driving a culture of quality excellence across the organisation.

Key Responsibilities

• Act as the site Qualified Person (QP) and named Quality Controller.
• Lead the QA and QC teams (approximately 5 direct reports), providing coaching, development and performance management.
• Ensure ongoing compliance with GMP, HPRA, Product Licence and regulatory requirements.
• Oversee batch certification, product release, deviations, CAPAs, change controls and investigations.
• Maintain inspection readiness and lead regulatory inspections, audits and supplier qualification activities.
• Own and continuously improve the site Quality Management System (QMS).
• Support new product introduction, validation activities and continuous improvement initiatives.
• Manage product complaints, recalls and quality agreements where required.
• Partner with site leadership to support operational performance while maintaining the highest quality standards.

Requirements

• Degree qualification in Pharmacy, Chemistry, Pharmaceutical Sciences, Biology or related discipline.
• Minimum 3 years operating on an HPRA licence.
• 5+ years' experience within GMP-regulated pharmaceutical manufacturing.
• Strong knowledge of EU GMP, HPRA regulations, quality systems and compliance requirements.
• Proven leadership experience managing QA/QC teams.
• Experience leading inspections, audits, QMS improvements and validation activities.
• Excellent communication, stakeholder management and problem-solving skills.

Non Negotiables

• Sterile and Aseptic experience
• Pharmaceutical GMP experience
• QP experience of 3+ years