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.
