Biora Therapeutics

Technical Program Manager

• Develop comprehensive project plans, including timelines, milestones, and deliverables, aligned with corporate objectives.
• Facilitate detailed planning sessions and ensure all project activities are tracked and managed to completion.
• Integrate design controls and risk management processes into project plans, ensuring compliance with regulatory standards.
• Lead and coordinate cross-functional project team meetings, document decisions, and assign clear ownership for action items.
• Define and communicate roles and responsibilities for all team members.
• Foster accountability and collaboration across internal and external stakeholders.
• Oversee the completion of design control documentation, including requirements flow-down, capabilities flow-up, and critical-to-quality (CTQ) specifications.
• Ensure product and system-level requirements are established, integrated, verified, and validated throughout the project lifecycle.
• Collaborate with Quality Assurance to maintain compliance for project documentation and design history files.
• Drive resource allocation and task management, resolving conflicts and prioritizing activities with department managers.
• Proactively identify project risks, develop mitigation strategies, and maintain unified cadence to meet milestones.
• Establish and publish project dashboards and key performance indicators (KPIs) to monitor progress and highlight risks.
• Implement new standards for requirements and specifications development, management, and traceability.
• Continuously improve project management processes to enhance efficiency and compliance.