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QC Stability Manager / Senior Scientist

Job Responsibilities

The Stability Manager/Senior Scientist is responsible for managing all aspects of the stability program and ensuring compliance with internal procedures, industry regulations, and regulatory guidance documents. As the process owner, the Stability Manager/Senior Scientist is responsible for implementing process improvements that drive benefits to efficiency, effectiveness, compliance, and robustness.

  • Execute and manage the commercial and clinical development stability program and maintain compliance with both ongoing and new regulatory requirements.
  • Manage and facilitate completion of all stability-related tasks
  • Review specification changes for product, API, and packaging components to assess impact to Regulatory Stability Protocols and revise protocols as needed using appropriate change management systems.
  • Interface with Manufacturing, Formulation and Analytical Development, QC, QA, and Regulatory Affairs regarding stability indicating methods, testing, and results.
  • Manage stability inventory, maintaining schedule of stability pulls, testing deadlines, and reporting deadlines.
  • Write/review/approve SOPs and work instructions.
  • Assist in the preparation of various stability summaries and reports as well as authoring relevant stability sections of regulatory submissions.
  • Ensure all cGMP stability data are managed and evaluated as described in relevant internal SOPs (including OOSs/ deviations).
  • Provide assistance in OOS, OOT and LI investigations, both stability and QC related.
  • Complete corrective and preventive actions assigned by investigations or audit observations.
  • Evaluate and continuously improve stability systems, quality and compliance with regulatory requirements, best practices and guidance, and quality systems policy and procedures.

Job Qualifications (Education, Certifications, Experience)

  • Master’s degree in a scientific discipline or equivalent experience. An advanced scientific degree is desirable with some knowledge of statistical analysis using a software like JMP.
  • Previous experience with conducting stability studies with Biological molecules.
  • Experience with statistical applications for stability data evaluation and shelf-life determination.
  • Extensive technical experience in a Quality Assurance, Quality Control and Manufacturing GMP environments preferably from the pharmaceutical industry supporting clinical or licensed products.
  • Proven experience with various quality processes (e.g. investigations/deviations, CAPAs, change controls, etc.).
  • Excellent working knowledge of GMP regulations for stability programs and laboratory applications is required.
  • Good oral and written communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory.