【上海 Qualification & Validation Manager(认证经理）招聘】-猎头顾问上海招聘信息-猎聘

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项目经理 · 上海德艾人力资源有限公司

简历处理快

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职位介绍: Job Overview Our client is recruiting a seasoned Qualification & Validation Manager to perform qualification and validation work for pharmaceutical and biotech capital investment projects. This role takes full ownership of end-to-end project quality compliance, ensuring all deliverables strictly comply with client requirements and global regulatory standards issued by health authorities. You will serve as the core technical liaison connecting internal stakeholders, external clients and regulatory authorities, and deliver efficient, fully compliant and high-standard engineering validation deliverables. Job Responsibilities 1. Validation Project Governance: Take full lifecycle management of pharmaceutical/biotech capital investment C&Q (Commissioning & Qualification) projects, including reviewing and approving core validation documents: VMP, Validation Plan, SIA, SRA, RTM, DQ/IQ/OQ/PQ protocols and reports; supervising on-site test execution, independently identify and resolve critical technical and compliance obstacles throughout project delivery. 2. Regulatory & Compliance: Oversight Interpret and apply domestic and international pharmaceutical regulatory requirements (NMPA GMP, FDA cGMP, EU GMP) as well as industrial guidelines (ISPE, WHO, PDA); participate in establishing, updating and rolling out the company’s unified qualification & validation management SOPs, guarantee all project activities comply with the latest regulatory revisions, and provide full technical support for client regulatory inspections. 3. Technical Standardization & Continuous Improvement: Develop internal validation technical templates, document writing specifications and field execution standards; summarize recurring project technical pain points, participate in cross-department optimization initiatives to simplify validation workflows, shorten project lead time and elevate document quality and on-site execution efficiency. 4. Client & Stakeholder Management : Act as the primary technical point of contact for internal and external clients; conduct regular technical alignment, requirement confirmation and project progress reporting; lead negotiations regarding validation scope, schedule adjustments and deviation disposal; design customized compliant technical solutions to meet client expectations and sustain long-term cooperative relationships. 5. Cross-department Collaboration & Risk Control: Maintain close coordination with engineering, procurement, project management and customer service teams; conduct early compliance risk identification through systematic SIA/SRA, formulate targeted risk mitigation plans and track full-cycle risk closure across all project phases. Qualifications & Professional Background 1. Bachelor’s degree or above in Pharmacy, Biotechnology, Pharmaceutical Engineering, Chemical Engineering or other relevant disciplines. 2. Minimum 15 years full-time hands-on qualification & validation experience in pharmaceutical/biotechnology manufacturing industry. 3. In-depth practical knowledge of NMPA GMP, FDA cGMP, EU GMP; proficient in ISPE, WHO, PDA commissioning and qualification guidelines with abundant real-project application experience. 4. Comprehensive mastery of full-set C&Q document system (VMP, VP, SIA, SRA, RTM, DQ/IQ/OQ/PQ); outstanding capability in reviewing high-level technical validation documents, guiding protocol/report compilation and supervising on-site testing execution. 5. Fluent written and verbal English; capable of independent regulatory communication, document review and client technical meetings in English.

其他信息: 语言要求：普通话 + 英语; 行业要求：人力资源服务

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