Director of Operations – Biorepository

Job Description Summary

Site Director will be responsible for overseeing all aspects of operations, management, and strategic direction of the biorepository. This includes ensuring that biological samples are collected, stored, and processed in compliance with regulatory standards and best practices. The Site Director will lead a team of professionals while working collaboratively with other departments and external partners to ensure the highest level of quality, efficiency, and compliance

Key Responsibilities

How will you make an impact & Requirement

• Leadership & Management:
• Provide leadership and strategic direction for the biorepository site, ensuring alignment with organizational goals.
• Lead, mentor, and manage the biorepository team, including scientists, technicians, and support staff.
• Foster a culture of collaboration, accountability, and continuous improvement.
• Oversee staffing, training, and performance management to ensure a highly skilled and efficient team.
• Operations Management:
• Ensure the biorepository operations adhere to relevant regulatory guidelines, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and ISO standards.
• Oversee the daily operations of the biorepository, including the receipt, processing, storage, and distribution of biological samples.
• Develop and implement Standard Operating Procedures (SOPs) to ensure consistency and quality in biorepository operations.
• Monitor and maintain the integrity of the sample inventory system and ensure accurate tracking of sample data.
• Compliance & Quality Assurance:
• Ensure compliance with all regulatory requirements for biosample handling and storage, including local, state, and federal regulations.
• Work with the Quality Assurance team to conduct regular audits, inspections, and validations to maintain high operational standards.
• Troubleshoot and resolve any compliance issues that arise, ensuring minimal impact on operations.
• Stakeholder Engagement:
• Act as the primary point of contact for internal and external stakeholders, including researchers, sponsors, and regulatory agencies.
• Collaborate with scientific teams to align biorepository operations with research needs and objectives.
• Participate in project planning and contribute to protocol development to support biosample collections and studies.
• Budget & Resource Management:
• Oversee the budget and resource allocation for the site, ensuring cost-effective operations without compromising quality or compliance.
• Prepare and present reports to senior leadership regarding site performance, challenges, and improvement initiatives.
• Safety & Risk Management:
• Ensure the implementation of health and safety policies and procedures to maintain a safe working environment.
• Identify potential risks related to sample integrity, compliance, or facility management and develop strategies to mitigate them.