Associate Director of Quality Compliance & Validation

Almac Group

Craigavon, United Kingdom

The Opportunity

Due to continued growth, we are now seeking an Associate Director – Quality Compliance & Validation to provide leadership across the Craigavon site’s Validation and Quality Compliance teams. This is a key leadership role where you will oversee the systems, people and processes that help ensure our facilities, equipment, utilities and computerised systems remain in a compliant and controlled state, while also supporting the effective operation of the wider pharmaceutical quality system at the Craigavon site.

In this role, you will lead experienced managers and specialist teams, providing direction, governance and oversight across site quality compliance and validation activities. You will play an important part in maintaining inspection readiness, monitoring quality performance, identifying opportunities for continuous improvement, and ensuring the business is supported with the right resources, skills and systems to meet both operational and regulatory expectations.

This opportunity would suit a strong quality leader who enjoys working across teams, influencing at a senior level, and driving high standards in a fast-paced pharmaceutical manufacturing environment. You will also act as a subject matter expert in good manufacturing practice, internal quality processes and validation strategies contributing to projects, audits, inspections and strategic quality improvements across site.

Key responsibilities include:

Leading the Validation and Quality Compliance teams on the Craigavon site
Providing governance and oversight of site quality systems and validation activity
Ensuring facilities, equipment, utilities and computerised systems are maintained in a compliant state
Monitoring quality and performance metrics and driving improvements
Supporting regulatory inspections, client audits and internal audit activity
Acting as an escalation point for complex compliance and validation issues
Representing Quality Assurance and/or Validation on cross-functional and site-wide project teams

What you need to be successful

To succeed in this role, you will bring significant leadership experience within a pharmaceutical quality environment, along with a strong understanding of regulatory expectations governing the manufacture of medicinal products in Europe. You will be confident leading teams, influencing stakeholders, solving problems, and driving a culture of compliance and continuous improvement.

We are particularly interested in hearing from candidates who have:

A degree level qualification in a science-related discipline
Significant experience managing a diverse quality function supporting the development and maintenance of pharmaceutical quality systems.
Experience in the development and application of validation strategies for facilities, equipment, utilities and computerised systems.
Experience in the quality and validation aspects of solid oral dose forms.
Strong working knowledge of pharmaceutical quality management systems
Proven knowledge of UK, EU and US regulatory requirements governing the pharmaceutical industry.