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Job Detail

Stability Quality Assurance Manager

Experience Level

6+ Year(s)


Fredrick, MD

Posted Date

Job Requirements

Ideal Candidate Profile:
-Experience with stability program management of biologics products
-Experience with license management
-Experience with continuous improvement processes
-Experience with LIMS is a big plus

Job Description:
The Stability Program Manager is responsible for quality assurance, in relation to all aspects of global commercial stability management and will evaluate stability information to support license management. The job holder has responsibility for commercial product portfolio and ensures compliance of this with AstraZeneca’s commercial stability obligations. The job holder communicates with stakeholders and project team members, advising and influencing them in the area of product stability.

Job Responsibilities:
Responsible for ensuring compliance with AstraZeneca’s commercial stability obligations through designing, implementation and maintenance of the Stability Program for biologics products. The core responsibilities include:

  • Generation and maintenance of the Stability Program for assigned products (drive stability study designs, author protocols, GQCLIMS Stability Static Data-load in collaboration with key stakeholders
  • Plans, designs, and executes multiple simultaneous projects that are complex and technically demanding through significant interactions with internal and external cross functional stakeholders.
  • Acts as a subject matter expert for stability program of assigned products. Drives the implementation of post marketing changes (new container closure systems etc) into stability program.
  • Supports technology transfers by coordinating with sending units to ensure seamless transfer of stability programs.
  • Ensures that assigned biologics stability program fulfils all regulatory requirements, and is optimized and effective.
  • Supports all stability data communication to customers
  • Supports regulatory submissions (author/co-author relevant regulatory filing sections).
  • Technical support related to Stability (Product Complaint, Deviations, Change Controls).
  • Supports regulatory agency inspections for stability-related questions.
  • Identification of any issues that may result in stability related non-compliance with GMP, regulatory requirements or commitments.
  • Seek opportunities for continuous improvement, across all aspects of global stability management
  • To seek opportunities for continuous improvement across all aspects of Global Stability Management

The role demands thorough understanding of pharmaceutical stability testing and a full overview of Operations activities and how this contributes to achieving the objectives of the business.

Essential Qualifications:

  • Strong communication skills (listening, verbal and written in English)
  • Excellent team working skills.
  • Accurate and thorough information handling.
  • Able to analyse qualitative and quantitative stability information in order to draw conclusions and make recommendations.
  • Recognizes different perspectives and is able to communicate with others to influence positive outcomes.

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