Senior QA Specialist - VLE

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

Job summary

VLE Therapeutics is seeking an experienced Senior QA Specialist to provide expert QA oversight across its Pharmaceutical Quality System (PQS). The role will act as a SME for deviations, CAPA, change control, QRM, validation and supplier quality, aligning with GMP and regulatory requirements.

Working with the Senior Quality Manager, QP, and QA team, you will support manufacturing, QC, supply chain and GxP operations while driving continuous improvement and inspection readiness.

Qualifications

• Minimum 5 years of QA experience in a GxP-regulated biopharma or pharmaceutical environment.
• Demonstrated expertise in PQS elements including deviations, CAPA, change control, and QRM.
• In-depth knowledge of GMP regulations (FDA, EMA, ICH).
• Experience with external service provider oversight, quality agreements, and supplier quality management.
• Experience in QMS validation and qualification desirable.
• Strong interpersonal, communication, and project management skills; cross-functional influence.
• Experience supporting regulatory inspections and delivering inspection readiness initiatives.

Responsibilities

• Serve as QA SME for PQS elements across deviations, change control, complaints, validation and QRM.
• Manage and execute operational QA activities to ensure timely, compliant records.
• Oversee review and approval of SOPs and controlled documents; author QA procedures.
• Develop, monitor and report quality metrics to drive timely QA actions.
• Partner with Senior Quality Manager, QP and QA team to achieve PQS objectives.
• Provide QA oversight for Master Batch Records and batch documentation.
• Lead QRM activities in alignment with ICH Q9 and risk mitigation.
• Support development and expansion of QA service capabilities.

Skills

QA oversight

GxP knowledge

QRM

CAPA

Deviation management

Change control

Supplier quality

Regulatory inspections

Education

Bachelor’s degree in life sciences/chemistry/engineering

Job description

About VLE Therapeutics

with a local supply chain for these critical medicines. To create the best client experience, we are creating and implementing a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver as a Medicine Accelerator. This is a unique opportunity for the successful candidate to become involved in ATMP and related pharmaceutical developments. The work we do is unique and our coexistence with APC on our campus gives us incredible opportunities to learn from and collaborate with, our APC colleagues, technically and personally in a shared modern and exciting cultural environment which makes VLE Therapeutics a great place to work.

Position Summary

We are seeking an experienced Senior QA Specialist to provide expert QA oversight across VLE’s Pharmaceutical Quality System (PQS). The role will act as a key SME across deviations, CAPA, change control, QRM, validation and supplier quality, ensuring compliance with GMP and regulatory requirements. Working closely with the Senior Quality Manager, QP and QA team, the role will support manufacturing, QC, supply chain and GxP operations while driving continuous improvement, inspection readiness and the effective delivery of quality systems.

Role Description

• Serve as QA Subject Matter Expert (SME) for core PQS elements, including deviations, change control, complaints, validation, and quality risk management (QRM) across manufacturing, supply chain, QC, and other GxP functions.
• Manage and execute operational QA activities to ensure timely and compliant record execution within the PQS.
• Oversee review and approval of SOPs and controlled documents; author and maintain QA-specific procedures aligned with regulatory expectations.
• Develop, monitor, and report Quality Metrics to drive timely execution of quality records and foster data-driven decision-making across the organization.
• Partner with the Senior Quality Manager, Qualified Person (QP), and QA team to deliver PQS objectives and drive continuous improvement across the system.
• Provide QA oversight and consulting in the development and review of Master Batch Records and executed batch documentation.
• Lead or facilitate Quality Risk Management (QRM) activities in alignment with ICH Q9 (Rev 1), ensuring proactive identification and mitigation of risks.
• Identify, propose, and implement continuous improvements in quality systems, with a focus on compliance, preventive maintenance, deviation and change control programs, and other GxP systems.
• Provide Quality Assurance oversight for internal manufacturing, materials management, warehousing, and QC testing operations.
• Oversee QA activities related to approved external service providers, including QC testing labs and material storage vendors:
• Lead preparation and review of Quality Agreements.
• Manage GxP supplier monitoring during onboarding and throughout their lifecycle
• Offer QA support and strategic direction for projects affecting manufacturing operations, including tech transfers and new process implementations.
• Contribute to inspection readiness efforts and regulatory inspections, including inspector interactions, observation responses, and follow-up action monitoring.
• Support development and expansion of VLE’s QA service capabilities to enable successful delivery of client-facing and commercial services (e.g., supplier quality management).
• Establish and maintain processes to support the QP team in the preparation, review, and communication of quality records and related documentation required for product release.

Experience And Education

• Bachelor’s degree in a scientific discipline (e.g., life sciences, chemistry, engineering); advanced degree preferred.
• Minimum 5 years of QA experience in a GxP-regulated biopharma or pharmaceutical environment.
• Demonstrated expertise in PQS elements including deviations, CAPA, change control, and QRM.
• In-depth knowledge of GMP regulations (FDA, EMA, ICH) and best practices in quality systems and operations.
• Experience with external service provider oversight, quality agreements, and supplier quality management.
• Experience in QMS validation and qualification desirable.
• Strong interpersonal, communication, and project management skills, with the ability to work cross-functionally and influence at all levels.
• Experience supporting regulatory inspections and delivering inspection readiness initiatives.

VLE is committed to the principle of equal opportunity for all employees. All employment decisions at VLE are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, marital status, or any other status protected by Irish law.