Overview
We’re supporting a leading global pharmaceutical organisation in appointing a senior Quality Director to oversee its GxP Audit and Inspection Readiness strategy.
This is a pivotal role for an experienced Quality professional who thrives on shaping global compliance frameworks, leading cross-functional teams, and driving inspection excellence across multiple GxP domains (GMP, GDP, GCP, GLP, GVP).
The successful candidate will provide strategic oversight of the organisation’s global audit programme, ensuring sustained regulatory compliance and inspection preparedness with agencies such as the MHRA, EMA, FDA, and PMDA.
Key Responsibilities
- Strategic Leadership: Define and execute a global GxP audit and inspection strategy that aligns with corporate Quality objectives.
- Audit Governance: Oversee internal and external audit programmes, ensuring risk-based coverage across all GxP areas.
- Inspection Readiness: Lead proactive inspection preparation activities, including mock inspections, training, and post-inspection remediation.
- Regulatory Intelligence: Monitor global regulatory trends and embed continuous improvement within the Quality Management System.
- Team Leadership: Inspire, coach, and develop a global team of GxP auditors and inspection leads to foster a culture of quality excellence.
Experience & Qualifications
- 10+ years of experience in GxP auditing and inspection management within the pharmaceutical or biotech industry.
- Strong leadership track record overseeing global Quality Systems and compliance operations.
- Proven experience engaging with health authorities during inspections.
- Strategic, detail-driven mindset with the ability to influence senior stakeholders globally.
- Scientific or technical degree (e.g., Life Sciences, Pharmacy, Chemistry, or related).
