MAJOR RESPONSIBILITIES AND DUTIES:

• Participate in the development and maintenance of an effective Quality Management System to include the development, maintenance, and management of company polices, SOPs and associated processes and procedures; this will include a “needs assessment” of company policies and procedures.

• Take a lead role in the management of the company’s GCP training program and other required clinical quality assurance-based trainings. Maintain records of employee training on policies, SOPs, and associated processes and procedures.

• Take a lead role in the development and maintenance of a document control system to ensure the company’s document change-control processes are consistent with industry best practices.

• Develop and maintain a Vendor Management System to include tracking tools to help ensure that the company’s vendors are appropriately qualified and/or requalified, as appropriate. Perform systems- and process audits of vendors, as directed.

• Conduct internal and external audits of drug development-related study records to assure compliance with regulatory requirements and company SOPs.

• Participate in preparations for regulatory inspections/mock regulatory inspections.

• Perform quality assurance reviews of clinical documents to include protocols, Informed Consents, Investigator Brochures, Trial Master Files, clinical labels.

• Take a lead role in developing and maintaining a Nonconformance (deviation) Management System to include appropriate documentation, investigations and tracking of SOP and/or protocol deviations, corrective and preventative actions (CAPAs) and their resolution.

• Assist with the preparation and submission of regulatory documents including but not limited to correspondence, briefing documents, INDs/NDA applications, and amendments/supplements.

• Provide input to clinical functions to ensure that clinical trial activities are conducted by CROs in compliance with GCP guidelines, applicable legislation, and internal requirements.

• Participate in the development of QA strategies for projects and programs.

• Provide support for business development activities as directed.

• Assist with non-clinical pharmacology, toxicology, and chemistry manufacturing and control (CMC) study quality-assurance activities.

• Apply critical thinking and problem-solving skills to identify potential compliance issues and offer solutions.

• Collaborate with functional teams to provide quality guidance and assistance with development of documents and processes using risk management principles.

Qualifications:

• Bachelor's degree or equivalent experience in Medicine or related field

• 5+ years' relevant work experience

• Highly organized with excellent attention to detail

• Fluent both in English and Mandarin

Base:

San Diego

Salary:

US$93K/Year - US$120K/Year

About Us

Cali Biosciences is an international biopharmaceutical company dedicated to the research and development of innovative drugs. We have an international team of scientific research and management talents and is developing new drugs based on several licensed technology platforms. We focus on the R&D of perioperative drugs. The product pipeline includes new drugs in the fields of anesthesia, analgesia and anti-inflammatory. In the future, we will also promote the commercialization of products to fully respond to the unmet market demand.

The company focuses on the research and development of innovative drugs, with laboratories and offices in Shenzhen, China, and offices in San Diego, USA, and a clinical center in Shanghai, China.

The company's main business is the research and development, and commercialization of innovative drugs. The current product pipeline consists of several modified new drugs based on the 505(b)(2) regulatory pathways. During the R&D process and upon completing the clinical trials, we seek approval from China, US and EU regulatory agencies and aiming at bringing innovative drugs in global markets. We are building a perioperative medication (anesthesia, analgesia and anti-inflammatory) pipeline to meet the global unmet needs. At present, we have several clinical and pre-clinical stage drug candidates, the target market of the product pipeline is huge, and the clinical needs are clear. All the products in pipeline are complex injectable products covered under high technology patent.

Our mission is to improve the length and quality of human life.

Cali Biosciences

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Quality Assurance Manager