QA Manager

Location
San Diego, CA
Posted
Nov 02, 2018
Required Education
Bachelors Degree
Position Type
Full time

Come join our world-class team evaluating, in-licensing and developing novel Chinese therapeutic product opportunities for international development.

HUYA Bioscience International is a leader in enabling and accelerating the global co-development of novel biopharmaceutical product opportunities originating in China. With the largest Chinese compound database covering all therapeutic areas, HUYA has emerged as the partner-of-choice for building and maximizing the value of biopharmaceutical innovation from China. HUYA is jointly headquartered in San Diego, CA, and Shanghai, PRC.

HUYA Bioscience International is seeking a highly motivated QA Document Control Manager to join our dynamic organization.

This position is an integral part of the Quality Assurance Department at HUYA Bioscience International.  The candidate is expected to assist with general QA activities in support of Quality Systems and collaborate on the design, implementation, and maintenance of HUYA’s GXP Document Control functions.

Responsibilities include but are not limited to:

  • SOP and Controlled Forms generation, approval and distribution support (e.g., processing of DGCRs for document revisions or generation of new documents)
  • Support the Document Control function to ensure that SOPs, Forms, Policies & Directives are generated, complete, accurate, approved, released, and distributed
  • Ensure only current revisions of SOPs and controlled forms are available to end-users
  • Populate the HUYA Share Drive with PDF copies of controlled documents
  • Support the biennial review of SOPs
  • Maintain complete and accurate GXP Training Files
  • Support assignment and tracking of HUYA Quality System documentation, e.g. DGCRs, CAPAs, Deviation Reports, Investigations, etc., and associated administration and follow up.
  • Maintain tracking databases to ensure appropriate control of GXP Documentation
  • Follow up with corrective action assignees as required to facilitate on time completion of assigned activities and timely CAPA closure.
  • Support Specifications/ BRs/Protocol approval for activities at CMOs for API, DS, DP, and labeling
  • Maintain GXP inspection readiness for Document Control Files and Quality Systems documentation for inspection by Regulatory Agencies, or due diligence audits by potential licensing partners
  • Ensure documents and files are readily available for review
  • Ensure that copies issued to inspectors/auditors are properly processed
  • Map the Document Control Files to ensure quick access to documents when required

Job Requirements:

  • The interested candidate must have a minimum of an undergraduate degree in Biology, Chemistry, Biochemistry, or related field.
  • Applicant must have a minimum of 5-7 years of experience with a focus on Quality Assurance in the Biotechnology and/or Pharmaceutical Industry.
  • Must have an expertise in cGMP Compliance and implementation and support of Quality Systems.
  • The successful candidate must have a meticulous eye for detail, polished organizational skills and good written and verbal communication skills.
  • A command of Microsoft Office, specifically Word, Excel, Access, and Power Point is required
  • Experience in GCPs and GLPs is desired.