Introduction to role: Are you ready to ensure every technical transfer milestone delivers safe, compliant, and reliable outcomes that reach patients faster? Step into a pivotal role where your quality leadership drives right-first-time manufacturing at contract partners and accelerates the journey from development to commercial supply. You will join a highly collaborative network of development, clinical supply, and external manufacturing teams working to bring complex biologics to life.
Your expertise will align critical process parameters and quality attributes, shape risk-based decisions, and translate data into action. Can you picture yourself being the voice of quality at the table, guiding CMOs through engineering and PPQ runs, and turning insights into sustainable improvements? Accountabilities: - Quality Leadership: Serve as the quality lead with Product Development/Clinical Supply (PDCS) teams, External Manufacturing and Operations (EM&O), and key stakeholders to ensure on-time delivery of technical transfer projects and robust GMP outcomes.
- GMP Oversight: Provide oversight of GMP systems executed by CMOs and the External Supply Chain for Drug Substance and Drug Product to maintain consistent compliance and readiness for clinical and commercial supply. - CMO Documentation Compliance: Review contractor documents, including batch records, deviations, and change controls, to verify alignment with procedures and standards; track and drive effective implementation to closure.
- GxP Guidance: Guide ongoing document reviews and approvals and provide pragmatic GxP advice aligned to current guidelines and regulations, embedding quality by design principles. - SOP and Audit Support: Approve organization-specific SOPs and controlled documents issued by CMOs; support audits and pre-approval inspections to sustain inspection readiness and regulatory confidence. - Metrics and Continuous Improvement: Develop and issue quality metrics for technical transfer activities; use these insights to prioritize process improvements and strengthen risk control.
- Transfer Performance Insight: Trend and analyze quality aspects of technology transfers to measure KPIs, identify opportunities for continuous improvement and risk mitigation, and propose and lead implementation of CAPAs. - Deviation and Risk Management: Review and assess deviations, perform risk assessments, participate in root cause analyses, and ensure timely tracking, follow-up, reporting, and trending to prevent recurrence.
- QA Project Support: Support QA in guiding projects and technical meetings; document and report compliance issues to management with clarity and impact. - Coaching and Enablement: Mentor early-career team members on quality processes, digital tools, and compliance requirements to elevate team capability and consistency. Essential Skills/Experience: • B.Sc. degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.
• >5 years’ cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial technology transfers. • Experience providing QA oversight across end-to-end technical transfers for biologics—reviewing/approving transfer plans and protocols, ensuring CPPs/CQAs are aligned and compliant. Supporting engineering and PPQ runs including associated deviations, CAPA, and change controls.
• Understanding of pharmaceutical bulk and drug product development and manufacturing. • Experience working with contract manufacturing/laboratory organisations essential. • Knowledge of quality management systems and regulatory requirements. • Demonstrated ability to understand and solve complex scenarios, and make appropriate, risk-based decisions. • Proven ability to collaborate effectively and sensitively across all levels of the organization, including senior leadership and external partners.
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