Quality Manager — Pharmaceutical Manufacturing, Ireland (Contract)

Myn; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Myn is seeking an experienced Quality leader to own the site Quality function in Galway. You will ensure product quality, regulatory compliance, and audit readiness across manufacturing operations in a fast-paced GMP environment.

This hands-on role requires effective people management, strong knowledge of EU GMP/HPRA, and proven experience supporting regulatory inspections and CAPA/change control. A fixed-term engagement with a cross-functional quality team is expected.

Qualifications

• Degree in a relevant scientific discipline.
• Substantial experience in a Quality role within pharmaceutical or biopharmaceutical manufacturing.
• Hands-on involvement in regulatory inspections (HPRA and/or FDA).
• Experience with deviation, CAPA, change control and electronic QMS platforms.

Responsibilities

• Provide day-to-day leadership of the site Quality Assurance and/or Quality Control function, managing a team of QA/QC Officers/Specialists.
• Ensure ongoing compliance with EU GMP, HPRA requirements, and applicable ICH guidelines across manufacturing operations.
• Own deviation, CAPA, change control, and complaints management systems with root-cause resolution.
• Lead batch record review and product release activities to ensure right-first-time quality.
• Prepare the site for regulatory inspections and customer audits.
• Maintain and improve the site's Quality Management System (QMS) to be audit-ready.
• Drive quality metrics reporting and trend analysis, escalating risks to site leadership.
• Support validation, technology transfer, and new product introduction from a Quality perspective.
• Coach and mentor the Quality team and liaise with cross-functional stakeholders.

Skills

Leadership

Quality Assurance

Regulatory compliance

Audits/inspections

Problem-solving

Cross-functional collaboration

Education

Degree in life sciences

Tools

Electronic QMS

Job description

Role Overview

The successful candidate will take day-to-day ownership of the site Quality function, ensuring product quality, regulatory compliance, and audit/inspection readiness across manufacturing operations. This is a hands-on leadership role suited to an experienced Quality professional who can be effective quickly, with minimal ramp-up time, in a fast-moving GMP manufacturing environment.

Role Overview

The successful candidate will take day-to-day ownership of the site Quality function, ensuring product quality, regulatory compliance, and audit/inspection readiness across manufacturing operations. This is a hands-on leadership role suited to an experienced Quality professional who can be effective quickly, with minimal ramp-up time, in a fast-moving GMP manufacturing environment.

Key Responsibilities

• Provide day-to-day leadership of the site Quality Assurance and/or Quality Control function, managing a team of [QA/QC Officers/Specialists].
• Ensure ongoing compliance with EU GMP, HPRA requirements, and applicable ICH guidelines across all manufacturing operations.
• Own the site's deviation, CAPA, change control, and complaints management systems, ensuring timely, root-cause-driven resolution.
• Lead or coordinate batch record review and product release activities, ensuring right-first-time quality and on-time release.
• Prepare the site for, and directly support, regulatory inspections (HPRA, FDA, or other applicable authorities) and customer/client audits.
• Maintain and continuously improve the site's Quality Management System (QMS), ensuring documentation is audit-ready at all times.
• Drive quality metrics reporting and trend analysis, escalating risks to site leadership as appropriate.
• Support validation, technology transfer, and new product introduction (NPI) activities from a Quality perspective.
• Coach, mentor, and performance-manage the Quality team, fostering a strong quality culture across the site.
• Liaise with corporate Quality, Regulatory Affairs, and other cross-functional stakeholders as required.

Essential Qualifications & Experience

• Degree in a relevant scientific discipline (chemistry, biology, pharmacy, or related life sciences field).
• Substantial experience in a Quality role within pharmaceutical or biopharmaceutical manufacturing, including demonstrable people-management experience at Quality Manager level or equivalent.
• Strong working knowledge of EU GMP, HPRA regulatory requirements, and ICH Q-series guidelines.
• Proven track record of direct involvement in regulatory inspections (HPRA and/or FDA) with successful outcomes.
• Hands-on experience with deviation/CAPA/change control systems and electronic QMS platforms.
• Available to start within a short notice period, given the contract nature of the role.

Desirable Criteria

• Experience specific to the site's product type (e.g. sterile/aseptic manufacturing, biologics, oral solid dose, or medical devices).
• Six Sigma / Lean qualification, or demonstrable continuous improvement project experience.
• Prior contract/interim experience, with the ability to add value quickly in an unfamiliar site environment.
• Experience supporting technology transfer or new product introduction from a Quality standpoint.
• Qualified Person (QP) eligibility, where relevant to the site's release model (an advantage, not essential).

Person Specification

• Strong leadership presence, able to establish credibility quickly with both the Quality team and site leadership.
• Pragmatic, risk-based decision-maker, comfortable balancing compliance rigour with production timelines.
• Excellent communication skills, confident representing the site directly to regulatory inspectors and auditors.
• Resilient and adaptable, comfortable stepping into an established team and driving change where needed.
• Self-sufficient and effective from day one, given the fixed-term nature of the engagement.