Location: Craigavon, Northern Ireland
Hours: 35 hours per week, Monday – Friday. Flexible working pattern.
Business Unit: Almac Pharma Services
Open To: Internal and external applicants welcome to apply.
Ref No.: HRJOB11627
Overview
Within Pharma Services, Quality Assurance plays a critical role in ensuring global operations consistently meet the highest regulatory and compliance standards. The Director of Quality Assurance will lead the Global Quality Assurance team and the Craigavon-based Quality Compliance and Validation teams, overseeing development, implementation, and continuous improvement of the Global Pharmaceutical Quality System (PQS). The role shapes quality strategy across multiple sites, ensuring alignment with cGMP expectations of global regulatory authorities and supporting compliance and operational excellence.
Key Responsibilities
- Lead the Global Quality Assurance function and drive consistency across sites.
- Develop and oversee the global validation and qualification strategy.
- Ensure effective design and governance of the Global Pharmaceutical Quality System.
- Monitor compliance trends and advise senior leadership on risks and improvements.
- Support regulatory inspections and audits at a global and site level.
- Act as a senior Quality representative on cross‑functional teams involved in capital projects and business improvement implementation impacting the Global PQS.
- Provide leadership to Craigavon Quality Compliance and Validation teams.
Required Qualifications
- A degree in a scientific discipline.
- Significant experience in a senior quality management role with strategy development for a Pharmaceutical Quality System.
- Proven experience leading multifunctional and cross‑site teams.
- Experience in quality systems supporting manufacturing and packaging operations, particularly solid oral dosage forms.
- Experience developing and implementing validation and qualification strategies.
Desirable Criteria
- Postgraduate qualification in a scientific or quality-related discipline.
- Eligibility to act as a Qualified Person (QP).
- Experience in a Quality leadership position in a global pharmaceutical environment.
- Knowledge of lean/operational excellence principles within a pharmaceutical setting.
Reporting Line
- Reports to the VP of Quality Assurance.
- Leadership responsibility for Associate Director of Quality Compliance & Validation and Associate Director of Global Quality Assurance.
Collaboration & Travel
The role involves global collaboration and may require participation in regulatory inspections, audits, and key business projects.
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