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Danaher Corporation QA Lead in Shanghai, China

Total Quality Leader, Biomanufacturing Operations

Shanghai

Help us improve access to life-changing therapies that can transform human health

We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services to our customers and help them work, faster and safer, leading to better patient outcomes.

We are looking for a Total Quality Leader for our Shanghai Biomanufacturing Operations to lead our Quality team and collaborate closely with the business on priorities and customer projects. This position will be responsible for managing the Quality Management System supporting the Fast Trak Shanghai facility and ensuring quality and regulatory compliance for both non-clinical and clinical (Phase 1 & 2) manufacturing utilizing single-use technologies. He/she will represent Cytiva to external agencies and champion the evolution of the quality culture for Fast Trak & Biomanufacturing Services which includes; executing and driving site quality objectives, metrics, reporting and operating mechanisms. This role will report directly to the Cytiva Global Quality organisation, with dotted line reporting to the Regional Fast Trak Leader.

Do you have a passion for Quality Assurance? Then we would love to hear from you.

What you’ll do

  • Accountable for ensuring full quality and regulatory compliance of the Fast Trak Shanghai facility, through maintenance & monitoring of a GMP compliant Quality Management System.

  • Serves as a resource for related development activities such as Process Development, Cell Line Development, and Analytical Assay Development.

  • Reviews records (e.g., manufacturing batch records, release & stability testing data, SOPs, Deviations, Change Requests, and Corrective and Preventative Action (CAPA) reports).

  • Participates in Risk Assessment and Mitigation evaluation activities.

  • Responsible for hosting customers compliance and site qualification audits.

  • Responsible for set-up and implementation of training matrix for Fast Trak China team members

  • Responsible for qualification and re-qualification of manufacturing related equipment and facility

  • Responsible for communication with 3rd parties to perform environment monitoring

  • Responsible for collaboration with 3rd parities to maintain clean utilities

  • Responsible for management of GMP compliant warehouse

  • Guides functional team to complete protocols, reports and SOPs etc, and authorize all GxP related documents in line with cGxP requirements.

  • Leads the Quality Management System training program inclusive of Quality System training, cGMP Orientation and Annual Refresher training, Data Integrity & Good Documentation Practice, Deviation Writing and CAPA training.

  • Has the authority to stop production, issue product holds, release products and sign off on project milestones.

  • Oversees all Quality related communications to Fast Trak facility associates.

  • Oversees the corrective Action/Preventative Action activities and Complaint Handling Programs.

  • Reports on Quality System effectiveness and requirements to management reviews.

  • Make decisions about quality functional budget and people accountability.

Who you are

  • Master Degree is required, preferably in microbiology, cell biology, molecular biology, biochemical or chemical engineering, or related field

  • A minimum of 10 years working in biopharmaceutical or pharmaceutical or industry inclusive of Quality Assurance or Quality Engineering experience.

  • Prior upstream/downstream experience in drug biomanufacturing is preferred.

  • A minimum of 5 years supervisory/management experience is preferred.

  • Understanding of drug manufacturing QMS requirements and regulatory requirements including but not limited to NMPA regulations, FDA 21 CFR 210 & 211, ICH Q7, Q10 and application to the manufacture of biopharmaceuticals.

  • Exceptional analytical, problem solving & root-cause analysis skills.

  • Excellent organizational, presentation, meeting facilitation and technical writing skills.

  • Good English written and verbal communication skills

  • Experienced in managing project teams and working cross – functionally and at global level

  • Demonstrated collaboration & conflict resolution skills

  • Demonstrated expertise to effectively communicate within all levels of the organization

  • Ability to manage tasks independently and make independent quality decisions

  • Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies

  • Ability to travel globally to perform/support audits as needed.

  • Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Who we are

Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.

Want to know more? Experience life at Cytiva on our Careers website (https://jobs.danaher.com/global/en/cytiva) , Instagram channel (https://www.instagram.com/cytiva/) and LinkedIn page (https://www.linkedin.com/company/cytiva/) !

Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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