The Director of Compliance is responsible for overseeing the compliance functions, including creating quality processes, procedures, and associated documentation to maintain compliance with industry relevant regulations such as 21 CFR Part 11, GDPR, EudraLex Volume 4 Annex 11, and Good Clinical Practices (GCP). They bring a blend of IT and quality management knowledge and are always the most knowledgeable in the room on all things regulatory. They serve as the liaison between the company and customers and prospect QA departments. They are a thought partner with the CEO and other executive team in maintaining and improving a culture of quality. They maintain our quality management system and are always looking for ways to improve overall quality process efficiencies.
Responsibilities
- Ensures company’s software and internal processes comply with industry regulatory guidance such as 21 CRF Part 11, EudraLex Volume 4 Annex 11, and Good Clinical Practices (GCP)
- Manages all company SOPs (including updating, reviewing, and making them effective)
- Performs and/or coordinates Verification and Validation plan development and execution for software products and custom study development.
- Ensures the internal QMS is utilized appropriately to record organizational activities to include software/study development, server status and business continuity.
- Coordinates internal and external audits on consistent basis
- Contributes to external surveys, questionnaires, and inquiries on processes, our EDC product, and QA activities.
- Oversee Incident Tracking and Deviations to include CAPAs related to incidents / deviations.
- Conducts Vendor Assessments / Qualifications to ensure vendors meet company standards.
- Represent the company and all employees in the clinical research QA community and take the lead as QA Ambassador of the company
- Proactively monitor and maintain high levels of quality, accuracy, and process consistency in the QA organization
- Ensure all QA organization objectives are met in a timely fashion
- Support and coach team members in understanding existing and new regulations
- Monitor the accuracy and efficient distribution of QA audit / questionnaire reports and other intelligence essential to the Compliance organization.
- Provide input to senior leadership in the development and administration of sales incentive compensation programs
Requirements
- Bachelor’s degree in an analytically rigorous field (e.g., math, business, finance, etc.)
- Exceptional communication and interpersonal skills.
- Ability to analyze data and trends to drive informed decision-making.
- Ability to work effectively with little supervision, multitask, and be flexible.