Quality Assurance Stability Program Manager

1 month ago

Worthing, West Sussex, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full time

Position Overview:

The role of the Quality Assurance Stability Program Manager is pivotal in ensuring the integrity and reliability of stability testing processes.

Key Responsibilities:

  • Lead the stability testing initiatives, ensuring compliance with established protocols and regulatory standards.
  • Assist in the selection of batches for stability assessments, particularly in response to process changes or deviations.
  • Oversee the management of stability sample storage, including proper labeling and organization within controlled environments.
  • Deliver a high-quality sample management service to stakeholders, adhering to ICH guidelines and regulatory requirements.
  • Coordinate the planning and execution of stability trials in collaboration with relevant departments and laboratories.
  • Ensure timely reporting of stability results and manage the annual review process effectively.

Work Environment:

We foster a culture that promotes growth, safety, and inclusivity. Our compensation package includes a competitive salary, performance-based bonuses, comprehensive healthcare, retirement plans, and employee share schemes.

We support flexible working arrangements through our Performance with Choice initiative, allowing you to balance remote and in-office work.

In this role, you will:

  • Be responsible for the management of stability sample requests, ensuring accurate protocol design and adherence to quality management systems.
  • Maintain a database for stability samples, tracking storage conditions and expiration dates while managing storage capacity effectively.
  • Respond promptly to environmental alarms, documenting actions taken to rectify deviations from established conditions.
  • Review and approve laboratory data, contributing to investigations and identifying trends for continuous improvement.
  • Manage the Stability Annual Review process, aligning it with site schedules and supporting regulatory submissions.
  • Provide expert guidance on stability regulations and maintain up-to-date knowledge of best practices in the field.

Qualifications & Skills:

We seek candidates with the following qualifications:

  • A Bachelor's degree in a relevant field or equivalent professional experience.
  • Proven experience in a stability-focused role.
  • Strong report writing capabilities.
  • Familiarity with global stability regulations.
  • Extensive proficiency in software tools for data analysis and trend interpretation.
  • Understanding of the implications of change processes on stability requirements.

Preferred Qualifications:

Additional desirable attributes include:

  • Knowledge of site-specific systems such as LES, SAP, and VQMS.

About Us:

At GlaxoSmithKline, we are committed to advancing health through innovative science and technology. Our mission is to prevent and treat diseases, focusing on the immune system and leveraging data technologies across key therapeutic areas.

We believe in creating an environment where our employees can thrive, feel valued, and continue to grow professionally. As an Equal Opportunity Employer, we welcome diverse talent and are committed to fostering an inclusive workplace.

We encourage flexibility in work arrangements and invite you to explore opportunities with us.

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