Ensuring robust quality assurance systems and procedures are in place for pre-clinical activities through clinical trial operations
Ensuring non-clinical and clinical study execution are compliant with applicable GLP, GCLP, and GCP regulatory requirements
Regulatory compliance oversight of both internal functions and outsourced activities through audit activities
Collaborating with representatives from Clinical Operations, Biometrics, Clinical Development, Regulatory Affairs, Bioanalytical and Preclinical functions
Developing/improving quality programs and procedures
Overseeing/approving clinical and regulatory documentation
Evaluating internal systems and external clinical sites and vendors for compliance
Providing QA support for risk assessment and remediation
Developing and delivering training on good clinical practice concepts

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

Senior Director, GCP, GLP QA

Key skills