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About the Company
Dunbar Pharmaceuticals is a newly GMP-certified site specialising in niche, plant-based APIs with controlled drug status. We are a rapidly growing company committed to quality excellence, regulatory compliance, new product innovation, and sustainable growth. Our culture is collaborative, forward-thinking, and improvement-driven - ideal for someone who thrives in a dynamic, hands-on setting.
Role Purpose
This is a rare opportunity for an experienced Quality Assurance professional to step into a pivotal, highly visible role at a new GMP-certified site producing innovative, plant-based APIs in a tightly regulated sector. Reporting directly to an expert Director of Quality, you will be key to shaping and strengthening the site’s quality systems and culture from the very beginning.
You will join a small, empowered QA team with the autonomy, influence, and breadth to drive operational excellence, compliance, and continuous improvement across every aspect of site quality. This role offers far broader scope than typically found in larger organisations: you will act as a site expert on GMP, change control, CAPA, document management, and training, while also mentoring colleagues and directly supporting key decisions at strategic and operational levels.
This is the perfect next step for a senior QA professional who wants to move beyond routine QA work, into a position where you will build, improve, and own site quality processes, gain visibility with the executive team, and see the direct results of your expertise in business performance, audit outcomes, and company culture.
If you are ambitious, agile, and eager to shape the future of a unique, niche API facility, you will find both daily challenge and long-term career growth here.
Key Responsibilities
Quality System Leadership & Compliance
* Support the ongoing development, maintenance, and improvement of the Quality Management System (QMS) to meet and exceed GMP, HPRA, and industry standards.
* Ensure robust document control, version management, and data integrity for all quality documentation.
* Oversee and manage change control, supporting the management of minor and major changes including regulatory, process, equipment, and facility changes.
* Manage and close deviations and non-conformances, leading root cause analysis, corrective, and preventive actions (CAPA), with follow-up effectiveness checks.
Regulatory, Audit & Inspection Readiness
* Act as QA representative during internal and external audits, including HPRA and customer audits.
* Support audit preparation, response, and corrective action implementation under the direction of the Director of Quality.
* Help maintain the site in a state of audit readiness, ensuring regulatory documentation is complete and current.
* Assist with controlled drug management, including documentation, reporting, and liaison with regulatory authorities.
* Lead risk assessments using ICH Q9 risk management principles, driving improvements related to product quality, safety, and compliance.
* Deliver and monitor GMP training across the site, ensuring all staff are appropriately trained and up-to-date.
* Mentor and coach junior QA staff and cross-functional colleagues, helping embed a culture of quality and continuous improvement.
Computer Systems Validation, Data Integrity, and System Support
* Provide QA support for computerised system validation (CSV) activities, working collaboratively with the company's QA Validation Manager, IT and Engineering, and applying your experience with GAMP5 and Annex 11 compliance as appropriate. You do not need to be a CSV expert, but some working knowledge/experience is desirable.
* Oversee and review validation documentation for new and existing systems, ensuring appropriate risk assessments and QA oversight are in place.
* Champion a culture of data integrity and serve as a QA point of contact for related queries, audits, or regulatory issues.
* Lead or support regular reviews of systems and records to identify and address potential data integrity gaps.
* Ensure the secure management, traceability, and archiving of all quality records, including those related to controlled substances and batch release.
Cross-Functional Collaboration
* Provide QA input to site projects and new product introductions, collaborating closely with production, engineering, supply chain, and regulatory affairs.
* Communicate clearly with colleagues, management, external partners, and regulatory bodies as required.
Requirements
* Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related field.
* At least 5-10 years’ experience in GMP Quality Assurance, ideally in API or pharmaceutical manufacturing.
* Strong knowledge of GMP, ICH guidelines, and HPRA regulatory expectations. Experience in quality systems, change control, deviation/CAPA management, document control, audit support, and GMP training.
* Some experience with computer systems validation (CSV), GAMP5, data integrity, and/or electronic QMS platforms.
* Excellent communication, mentoring, and cross-functional collaboration skills; adaptable, hands-on, and proactive approach. Comfortable working in a small, dynamic team, willing to roll up sleeves and help build best practice from the ground up.
* Experience with controlled drugs and associated compliance.
* Previous involvement in a new facility start-up or small-team QA leadership.
* Familiarity with continuous improvement or lean projects.
* Highly visible, career-building role with direct access to site leadership and decision-makers.
* Significant autonomy and scope for impact and career growth in a fast-growing, ambitious business.
Note: This position is designed for a senior QA professional who wants to step up and help build a quality culture, not just maintain it - ideal for someone ready to take genuine ownership in a high-potential, growing company.
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