锦鲤求职岗位描述
Responsibilities:
Quality System Management & Compliance
• Oversee all GMP management programs and site operations to ensure full compliance with cGMP requirements across Chinese GMP, EU GMP, and 21 CFR Part 11/210/211, as applicable.
• Lead the site Quality Management System (QMS), governing the full lifecycle of change control, deviation management, and CAPA — ensuring timely execution, effectiveness verification, and closure.
• Coordinate and execute product recall procedures in alignment with regulatory requirements.
• Lead preparation and coordination for Health Authority inspections (PAI, GMP inspections, etc.) and customer audits / third-party due diligence.
• Establish and execute the self-inspection program, ensuring a risk-based annual plan is in place, execution is tracked, and findings drive continuous improvement of the quality system.
Quality Risk Management & Continuous Improvement
• Embed Quality Risk Management (QRM) principles — aligned with ICH Q9 — across all stages of the product lifecycle, from development through commercial manufacturing.
• Conduct risk-based gap assessments against evolving regulatory requirements; develop and execute risk-prioritized improvement plans.
• Chair periodic quality management review meetings to analyze key quality metrics (deviations, change controls, OOS/OOT/OOE, stability data, complaints, RFT, etc.) and drive data-informed improvement actions.
• Sponsor the data integrity improvement program; identify potential integrity risks and implement corrective actions to minimize or mitigate them.
Quality System Digitalization & AI Innovation
• Advance the paperless quality management vision by driving deep utilization of the VEEVA Quality platform — to eliminate manual inefficiencies and strengthen compliance.
• Champion lean management principles across the quality organization to streamline workflows, reduce waste, and accelerate cycle times for quality events.
• Implement early warning mechanisms and predictive analytics leveraging AI and data-driven tools to proactively identify recurring deviations, systemic quality issues, and emerging trends before they escalate.
• Lead the strategic deployment of AI-powered solutions within QMS, including AI-assisted root cause analysis, automated deviation trending, predictive quality analytics, and intelligent document review, to enhance operational efficiency and decision-making accuracy.
Team Development & Capability Building
• Coach and develop team members to strengthen GMP awareness, technical competence, and digital literacy, fostering a culture of innovation and continuous improvement.
• Build organizational competency in AI-enabled quality tools and digital quality systems to ensure sustainable adoption and effective utilization.
Requirements:
Education & Experience
• Bachelor's degree or above in pharmaceutical sciences or a relevant field.
• Minimum 15 years of experience in QA, Production, and/or QC within a pharmaceutical manufacturing site; multinational company experience preferred.
Regulatory & Technical Knowledge
• Solid GMP knowledge of non-sterile API and drug product, with working understanding of cGMP requirements across US, EU, and China regulations.
• Strong knowledge of Quality Risk Management (QRM) principles (ICH Q9) and risk-based approaches to quality decision-making.
Digital & AI Competency
• Proven experience in leading digital transformation initiatives within quality management, particularly with VEEVA Quality platform implementation and optimization.
• Demonstrated experience or strong strategic vision in applying AI and advanced analytics to quality management processes — including predictive analytics, automated trending, and intelligent decision support.
• Experience in establishing data-driven quality monitoring and early warning systems to proactively identify recurring deviations and systemic issues.
Leadership
• Strong leadership capability and strategic thinking; able to influence cross-functional stakeholders and drive organizational change.
Soft Skill
• Good communication skills.
• Fluent oral English and good written English skills.
• Good presentation capability.