Stability Manager

Supervision, coordination, and administration of stability operations, with a strong focus on team management and quality assurance.

Responsibilities:
Reporting to the Managing Director, specific responsibilities include but are not limited to:

Operational Activities:

• Oversee the daily operations of stability storage, ensuring that all processes are carried out efficiently and in compliance with regulatory standards.
• Manage the receipt, placement, and monitoring of customer product samples, ensuring accurate documentation and adherence to study protocols.
• Ensure that all stability operations are conducted in accordance with the company's Quality Management System (QMS) and current Good Manufacturing Practices (cGMP).
• Liaise with various departments, including Quality, to ensure seamless integration of stability operations with overall company objectives.
• Facilitate communication between team members, external consultants, and contractors to ensure alignment and efficient workflow.
• Maintain comprehensive records of all stability operations, including study paperwork, monitoring equipment logs, and QMS documentation.
• Ensure that all administrative tasks, such as responding to emails, maintaining invoices, and managing contractor reports, are completed promptly and accurately.
• Implement and oversee the use of new equipment and technologies to enhance stability operations.

Team Management:

• Lead and manage a team of operational staff, providing guidance, support, and performance feedback to ensure high levels of productivity and morale.
• Conduct regular team meetings to discuss progress, address challenges, and plan for future activities.
• Develop and implement training programs to enhance team skills and ensure compliance with regulatory standards.
• Foster a collaborative and positive work environment that encourages teamwork, innovation, and continuous improvement.
• Manage schedules, workloads, and performance for team members.

Quality Assurance:

• Oversee all QMS activities, ensuring that stability operations meet the highest quality and compliance standards.
• Monitor operations, identifying areas for improvement and implementing corrective and preventive actions (CAPA) as needed.
• Drive correct use of quality manuals and continuous improvement initiatives, working closely with management to drive quality improvements.
• Ensure that all planned and unplanned changes (deviations) are thoroughly investigated, documented, and addressed.
• Support the quality team with internal reviews and audits to ensure ongoing compliance with GMP certification and regulatory requirements.

Experience:

• • Proven experience working in a regulated environment.
  • 5+ years in team lead management or leadership roles.

Personal Attributes:

• • • Ability to lead and motivate a team, fostering a positive and productive work environment.
    • Excellent interpersonal and communication skills.
    • Strong problem-solving skills and a proactive approach to challenges.
    • Proficiency in IT tools (Word, Excel, Teams).
    • Commitment to continuous improvement and quality assurance.
    • Commercial awareness and business development skills.

Third Level Qualification in Science or a related field is desirable but not essential.