Director of Clinical Operations Quality - Remote

Overview

The Director of Clinical Operations Quality at BlueRock Therapeutics is responsible for leading the development and evolution of core SOPs, processes, and templates necessary to support the planning and execution of clinical studies.

In Short

• Lead the development of operational quality documentation.
• Manage Trial Master File standards and tools.
• Provide compliance consulting to clinical operations staff.
• Support audit readiness and risk mitigation initiatives.
• Foster a culture of collaboration and operational excellence.
• Collaborate with internal and external Quality Assurance stakeholders.
• Drive initiatives related to clinical compliance and inspection readiness.
• Establish strong collaboration across teams.
• Implement continuous improvement initiatives.
• Demonstrate strong leadership in a dynamic environment.

Requirements

• Bachelor’s degree in life sciences or related field.
• 10+ years in Clinical Operations in a pharma/biotech or CRO environment.
• In-depth knowledge of GCP, FDA, and ICH regulations.
• Experience with trial documentation and clinical quality.
• Strong interpersonal and organizational skills.
• Ability to manage multiple conflicting priorities.
• Experience in cell and/or gene therapy settings is a plus.
• Excellent verbal and written communication skills.
• Track record of driving clinical compliance initiatives.
• Familiarity with Veeva systems is preferred.

Benefits

• Dynamic and collaborative work environment.
• Opportunity to impact patient lives through innovative therapies.
• Commitment to scientific excellence and operational rigor.
• Inclusive culture fostering innovation and diversity.
• Remote or hybrid work arrangements available.