In particular, you can expect to:

?Ensure effective compliance to corporate, government, and other appropriate regulatory requirements (e.g. NMPA (i.e. CFDA), ISO, USFDA, EU IVDR, etc.).

?Ensure that all manufactured product meets required quality specifications throughout formulation, QC testing, bottling, assembly, packaging, and final release with appropriate labeling per local regulatory requirements.

?Establish and maintain the site Quality Management Systems and fulfill the NMPA requirements.

?Serve as Management Representative, and be the key contact with external entities (NMPA, USFDA, NB, etc.) regarding facility inspections, registrations, etc.

?Ensure that a highly competent, effective, and motivated QA team is in place to meet the needs of the business, including staffing, training, performance management, and personnel development.

?Develop a strong working relationship with internal partners to maximize productivity, efficiency, communication, and harmonization.

?Prepare, present, defend, and manage the site QA departmental budget and staff.

?Drive key changes and continuous improvement in site Quality systems and procedures.

?Manage quality metrics across the site, and ensure adherence to site quality targets.

?Serve as a Liaise between Corporate and China Distributor and support business growth.

To be successful, you will need:

?A minimum of 7 years of related experience in the medical device, pharmaceutical, and/or medical diagnostics industry, with at least 3 years of supervisory experience.

?Be a high energy, results-oriented leader with excellent collaboration and project management skills

?Possess sound judgment and decision-making capabilities in technical, business, and regulatory compliance arenas, with strong expertise of domestic and international regulatory compliance requirements (e.g. NMPA, FDA QSR and ISO/EN standards)

?Possess a deep Quality Engineering toolbox including Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Design for Six Sigma, Industrial Statistical Methods, Six Sigma and/or Lean Manufacturing.

?Experience developing and leading internal audit programs, and managing external inspections/audits (e.g. NMPA, US FDA, Competent Authorities, Notified Bodies).

?Effectively interface with internal partners.

Qualification required:

Education:

?Bachelor of Science degree in a scientific/technical discipline.

?Master of Business Administration or Science degree preferred.

?Six Sigma Black Belt or Master Black Belt strongly desired.

?Ability to fluently read, write, and speak in English and Mandarin is required.

Some logistics:

?Based in Shenzhen, China.

?Travel required up to 15%, including international.

Company briefings

As BioLegend strives for continued improvement and future growth, it seeks an experienced, passionate, and dynamic Quality Compliance Manager to oversee its Shenzhen, China site. This role will report to the Director of Quality Assurance (dotted line to the China Business Director), and have a hands-on role to establish and maintain a Quality Management Systems per applicable requirements of NMPA (CFDA). Hosts the on-site quality audit and serves as the key liaison with China Distributor for final product release with appropriate labeling and documentation for product distributions. Work with stakeholders for product registrations as needed.

上班地址：深圳市南山区沿山路43号创业壹号大楼A栋203室