The
Stability and Raw Materials Lead
is responsible for overseeing the finished product stability program and raw material management within Vantive's manufacturing and quality operations.
This role ensures compliance with global regulatory requirements, internal quality standards, and supports product lifecycle management. The position requires strong technical expertise, leadership skills, and the ability to collaborate cross-functionally to maintain robust systems for stability studies and raw material qualification.
Key Responsibilities:
Stability Program Management
* Develop, implement, and maintain stability protocols and schedules for commercial and development products.
* Ensure stability studies comply with ICH guidelines, regulatory filings, and internal SOPs.
* Review and approve stability data, trend analysis, and reports for regulatory submissions and annual product reviews.
* Manage stability chambers and ensure environmental monitoring compliance.
Raw Materials Oversight
* Lead raw material qualification and requalification processes in alignment with GMP and regulatory requirements.
* Collaborate with suppliers and internal teams to resolve material-related issues and ensure supply continuity.
* Maintain raw material specifications and ensure timely updates based on regulatory changes or process improvements.
Compliance & Documentation
* Ensure adherence to cGMP, ICH, and other applicable regulatory standards.
* Support audits and inspections by providing stability and raw material documentation.
* Drive continuous improvement initiatives within stability and raw material programs.
Cross-Functional Collaboration
* Partner with Quality Control, Product Development, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure seamless execution of stability and raw material-related activities.
* Provide technical guidance and training to team members and stakeholders.
Qualifications:
* Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field
* Experience in pharmaceutical stability programs and raw material management within a GMP environment.
* Strong knowledge of ICH guidelines, cGMP, and regulatory requirements.
* Excellent analytical, problem-solving, and organizational skills.
* Effective communication and leadership abilities.
Preferred Skills:
* Experience with stability chamber operations and environmental monitoring systems.
* Familiarity with LIMS for raw material and stability data management.
* Project management experience in a regulated environment.
What can Vantive offer to you:
* A stable and secure work environment.
* A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme.
* A collaborative and dynamic work environment.
* Access to state-of-the-art equipment and technology.
* Recognition and reward for outstanding performance.