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Role Description

The (Sr.) Director, GCP & GLP QA will ensure robust quality assurance systems and procedures are in place to cover REGENXBIO’s pre-clinical activities through clinical trial operations. You will also ensure non-clinical and clinical study execution are compliant with applicable GLP, GCLP, and GCP regulatory requirements as well as regulatory compliance of both internal functions and outsourced activities through oversight of audit activities, utilizing internal and external resources. You will have the opportunity to interface and collaborate with representatives from Clinical Operations, Biometrics, Clinical Development, Regulatory Affairs, Bioanalytical and Preclinical functions.

• Develops/improves quality programs and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards and implement risk-based methodologies to improve efficiencies
• Authors and/or reviews and approves Standard Operating Procedures (SOPs)
• Reviews/approves or audits clinical and regulatory documentation and other clinical data to ensure accuracy and data integrity for GCP, GLP and GCLP activities as required
• Evaluates internal systems and external clinical sites and vendors to determine acceptable compliance to applicable regulations and guidelines
• Provides QA support for risk assessment and remediation, and identification and investigation/CAPA of Critical Quality Issues as needed
• Oversees/approves non-clinical and clinical supplier and site audit/assessment schedules and facilitates the selection of contract auditors to support the clinical auditor program, as required and per defined budget
• Participates in or leads internal and vendor audits to ensure patient safety and data integrity
• Oversees clinical quality event and CAPA process
• Develops and delivers training on good clinical practice concepts and specific GCP procedures
• Represents QA at internal clinical and GCLP team meetings
• Supports key quality processes, metrics and indicators to measure trends and improve key quality determinants of GCP and supporting GxP operations
• Effectively communicates progress and issue resolution to appropriate internal/external stakeholders
• Stays up-to-date with current regulatory changes and industry trends and translates new requirements back to the company’s policies and procedures
• Facilitates/lead QA activities for GLP/GCP regulatory inspection management
• Promotes a culture of quality and operational excellence through leadership of clinical quality function and partnering with other departments throughout the organization
• Plans, resources, and manages staff to ensure efficient operations and encourage development of capabilities
• Must be able to travel up to 10-20% of time

Qualifications

• 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

• Market-competitive base salary
• Annual performance-based bonus program
• Stock grants at all levels
• Health, dental, and vision insurance
• Retirement plan with 401(k) match
• Summer hours
• Estimated compensation range for this role is $190,000 to $330,000 annually