QC Stability Manager
Location:
Limerick/Clare
Industry:
Pharmaceutical / Biotechnology
The Opportunity
Seeking an experienced QC Stability Manager to lead and oversee the stability programme within a pharmaceutical/biotechnology environment in Ireland.
This is an important leadership position, with responsibility for the successful delivery and ongoing management of stability studies for clinical and commercial products.The successful candidate will provide scientific and technical leadership across all aspects of the stability programme, including study design, protocol development, analytical data monitoring, statistical trending, reporting and regulatory compliance.
Working closely with Quality Control, Quality Assurance, Regulatory Affairs and other key stakeholders, you will support operational excellence, continuous improvement and a strong GMP culture, ensuring that stability activities consistently meet applicable regulatory requirements and business objectives.
Key Responsibilities
- Lead the design, coordination and execution of stability studies for clinical and commercial products, ensuring compliance with relevant regulatory guidelines and internal procedures.
- Develop, maintain and review stability protocols, reports, SOPs, technical memoranda, specifications and regulatory documentation.
- Generate and review stability reports, applying analytical expertise and statistical tools, including JMP, to interpret data and support shelf-life and expiry dating proposals.
- Monitor stability data, identify trends, assess potential degradation pathways and provide scientific recommendations to support product quality and lifecycle management.
- Ensure the stability programme remains aligned with FDA, EU, ICH and other applicable international regulatory requirements.
- Manage stability-related Quality Management System activities, including deviations, change controls, CAPAs and investigations, ensuring timely and compliant closure.
- Support the ongoing development, functionality and maintenance of stability-related processes and systems.
- Identify and implement continuous improvement initiatives to enhance the effectiveness, efficiency and compliance of the stability programme.
- Establish and monitor key performance indicators to support programme performance and continuous improvement.
- Work collaboratively with cross-functional teams to promote quality, GMP compliance and shared accountability.
- Ensure adherence to GMP, Data Integrity and Good Documentation Practice (GDP) requirements.
- Support team training and development, ensuring personnel are appropriately trained and qualified before undertaking GMP activities.
- Ensure GMP documentation and quality records are completed accurately, maintained to a right-first-time standard and closed within agreed timelines.
The Ideal Candidate
- A minimum of 5 years' relevant experience within the pharmaceutical or biotechnology industry.
- Strong knowledge of stability principles relating to biologics and pharmaceutical products, including degradation pathways, accelerated stability studies and shelf-life determination.
- Demonstrable expertise in analytical methodologies used in stability testing and the assessment of biologics.
- A strong understanding of FDA, EU and ICH regulatory guidelines, as well as relevant pharmacopeial requirements.
- Practical experience in stability data trending, statistical analysis and rate analysis to support retest period and shelf-life proposals.
- Experience using statistical software, particularly JMP, for stability data analysis and interpretation.
- A strong understanding of analytical method qualification and validation requirements for biologics and pharmaceutical products.
- Excellent attention to detail, with a strong commitment to accurate record keeping and high-quality GMP documentation.
- Good knowledge of pharmaceutical product development and associated development strategies.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.
The Opportunity
This is an excellent opportunity for an experienced stability professional to take ownership of an important function within an established pharmaceutical/biotechnology environment.
You will have the opportunity to contribute to stability strategy, drive technical and operational improvements, support team development and play an important role in maintaining the quality and lifecycle management of pharmaceutical products.
If you have a strong background in pharmaceutical or biologics stability and are looking for your next career opportunity, we would welcome your application
