
Posted 18 hours ago
GMP Compliance Lead
AstraZenecaGMP Compliance Lead
Requirements
GMP-regulated environment experience, GMP training design and delivery, Contamination control principles, Data integrity knowledge, QMS adherence promotion, Change management experience, Digital and AI tool awareness, Scientific or engineering degree
Skills
GMPQMSData Integrity
About the role
Responsibilities
- Lead and embed a proactive GMP and quality culture across operations and support functions
- Design, deliver, and evolve risk-based and competency-based GMP training programs
- Implement and sustain practical contamination control practices and expectations
- Use data trends and performance coaching to reduce human error and drive "Right First Time" performance
- Champion data integrity, compliant documentation, and disciplined record-keeping
- Maintain continuous inspection readiness through strong compliance practices and leadership
- Identify compliance risks and opportunities for continuous improvement using operational insight
- Lead change management initiatives affecting GMP practices, quality systems, and organizational behaviors
- Contribute to the implementation of digital and AI-enabled solutions to elevate compliance and learning
Requirements
- Significant experience working in a GMP-regulated environment (pharmaceutical or biopharmaceutical preferred)
- Strong working knowledge of GMP requirements and their practical operational application
- Experience in GMP training design, delivery, and effectiveness measurement
- Sound understanding of contamination control principles and implementation
- Proven knowledge of data integrity requirements and compliant documentation practices
- Experience promoting QMS adherence and procedural discipline
- Demonstrated ability to lead, coach, and influence others to strengthen compliance behaviors
- Experience applying change management principles to support business transformation
- Awareness of digital and AI technologies within a quality or operational context
- Degree in a scientific, engineering, quality, or related discipline
Preferred Qualifications
- Experience in aseptic processing or cleanroom operations
- Familiarity with continuous improvement methodologies
- Experience using digital systems for quality or training management
About the Company
AstraZeneca is a global, science-led biopharmaceutical company that focuses on discovering, developing, and commercializing prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals. We combine scientific rigor with practical ingenuity to deliver life-changing medicines to patients worldwide.
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AstraZeneca · Dublin
