Senior Quality Engineer defining and executing quality strategies for AI - driven products. Collaborating on data engineering and application development for product reliability and user experience.
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
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