A career-defining opportunity has arisen for an experienced professional to take on the role of Senior Quality Strategist. The ideal candidate will possess a deep understanding of pharmaceutical quality and compliance, with a strong background in Quality Assurance (QA) and Quality Control (QC). They will be responsible for delivering expert guidance on quality and regulatory compliance to ensure that all pharmaceutical products produced and distributed meet the highest standards of safety, quality, and legal requirements.
Key responsibilities will include:
* Serving as a subject matter expert in pharmaceutical quality and compliance
* Providing functional leadership, including effective allocation and management of departmental resources to meet business goals
* Ensuring all quality system activities align with compliance requirements and organisational objectives
* Leading audit teams and coordinating with cross-functional departments to address findings and implement effective corrective actions
* Acting as a key interface with external regulatory bodies and supporting audits or inspections as needed
* Overseeing and managing the Pharmaceutical Quality Management System & Continuous Improvement
* Ensuring that all products meet applicable industry regulations and quality standards
* Supporting the site Qualified Person (QP) and acting as a backup QP as required
* Reviewing pharmaceutical products and ensuring their release complies with all relevant regulatory standards
The successful candidate will possess:
* A Bachelor's degree (Level 8) in Science or Engineering (Master's degree or higher, Level 9, is an advantage)
* 10+ years in pharmaceutical or biotech production, with a strong background in QA, QC, or Compliance
* At least 5 years in a managerial or leadership role in a quality-focused function
* Strong knowledge of cGMP, ICH standards, EU GMP Annexes, and FDA/HPRA requirements
* Experience as QP is an advantage