ZhenGe Biotech

Established in 2017, Shanghai ZhenGe Biotechnology Co., Ltd. (ZhenGe Biotech) is a premier high-tech enterprise registered in the China Pilot Free Trade Zone (Shanghai). ZhenGe Biotech has Development Centers in Shanghai and Innovation Center in Maryland USA, as well as cGMP and commercial manufacturing sites in Shanghai.  The core business of ZhenGe Biotech is to provide CDMO services to both biotech and pharmaceutical companies.

Our integrated CDMO services starting from pre-clinical research to commercial manufacturing, as well as customized cell culture media development, enable and accelerate the R&D and commercialization of innovative biologics for biotech and pharmaceutical companies worldwide.

Zencore Bio is the wholly owned subsidiary of ZhenGe Biotech, located in Germantown, Maryland.

Position: Quality Validation Director

Report line: SVP of Quality

Location: Shanghai, China

Responsibilities:

lLeading & manage & hiring validation team

lSchedule & planning for project validation & existing facility Q&V

lDrawing , URS, project management document develop & review

lTendering for CU & Validation package

lC&Q SOPs development

lQuality system SOP review

lCSV system sop review and existing facility gap analysis and improvement

lProcess validation & Cleaning validation plan and risk analysis

lCritical vendor tendering 

lPAS system validation clarification and system doc. review

Qualifications

lBachelor’s degree or above; major in biology, pharmacy, chemistry, etc.;

lAt least 10+ years of experience in macromolecular biopharmaceutical industry, and 5+ years of management experience in the biopharmaceutical field.

lRich experiencein the field of Qualification & Validation project management and execution, Quality system, Quality control supplier audit, research & development of pharmaceutical

lHave variety experiences in leading Project Commissioning & Qualification activities and practical project validation management & execution skills on facility and equipment.

lGMP compliance audit experience of pharmaceutical company.

lHave strong career-ambition and sense of responsibility; embrace goal- and result-oriented management model; have strong executive ability, resource integration ability, team management ability and good interpersonal skills.

Company provides competitive compensation package, including stock options.

For more information, please visit https://zgbiotech.com/en/, or contact us at hr@zgbiotech.co****>