Hybrid Director – GCP, GLP QA

at HDT Global

• Job title: Director – GCP, GLP QA
• Job type: Full Time
• Experience level: Senior
• Salary: $190,000 - $330,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, United States

About the role

• Director of Quality Assurance managing compliance in clinical trial operations for gene therapies. Involved in ensuring GLP, GCLP, and GCP regulatory compliance across various teams.

Responsibilities

• Ensure robust quality assurance systems and procedures are in place to cover pre-clinical activities through clinical trial operations
• Ensure non-clinical and clinical study execution are compliant with GLP, GCLP, and GCP regulatory requirements
• Oversee audit activities and ensure regulatory compliance of both internal functions and outsourced activities
• Interface and collaborate with representatives from Clinical Operations, Biometrics, Clinical Development, Regulatory Affairs, Bioanalytical, and Preclinical functions
• Develop and improve quality programs and procedures to ensure compliance with regulatory and industry standards
• Author and review Standard Operating Procedures (SOPs)
• Evaluate internal systems and external clinical sites and vendors for compliance
• Provide QA support for risk assessment and remediation
• Oversee clinical quality event and CAPA process
• Develop and deliver training on good clinical practice concepts and specific GCP procedures
• Support key quality processes and metrics to measure trends and improve quality determinants
• Communicate progress and issue resolution to stakeholders
• Stay up-to-date with regulatory changes and industry trends
• Lead QA activities for GLP/GCP regulatory inspection management
• Promote a culture of quality and operational excellence within the organization
• Manage staff to ensure efficient operations

Requirements

• BS, preferably in a biological science
• Must have direct job experience in a Clinical QA or GLP QA role
• Extensive experience conducting and overseeing audits
• Extensive knowledge of FDA and EU regulations as well as ICH guidelines
• Minimum of 10 years of experience in a Quality Assurance/Quality Systems/Clinical QA position in biopharma / biologics / cellular therapy / gene therapy in a regulated environment
• Excellent interpersonal skills and ability to effectively interact with and influence different functional groups at multiple levels of the company
• Ability to interpret regulations and practically apply them to procedures
• Excellent oral and written communication skills for effectively interfacing with internal and external organizations
• Strong project management skills
• Ability to manage multiple priorities with aggressive timelines and changing priorities
• Must have excellent attention to detail
• Possesses strong critical and logical thinking
• Basic proficiency in MS PowerPoint, Excel and Word

Benefits

• Health, dental, and vision insurance
• Retirement plan with 401(k) match
• Summer hours
• Annual performance-based bonus program
• Stock grants at all levels