Director, Product Quality Assurance (Trial Oversight)
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.
The Director, Product Quality Assurance is responsible for ensuring the operational quality status of all ERT Trial Oversight products/solutions deployed for production use in approved clinical trials that create regulatory grade data intended for regulatory submission. The Director will interface with the Operational and Strategic arms of Quality Management to obtain and disseminate inputs from the aforementioned teams to facilitate the definition and execution of quality strategies that will result in world class Trial Oversight products and solutions. The Director, Product QA will liaison with ERT Operational personnel, Product Line Executives and Product Managers.
Essential Duties and Responsibilities:
- Acting face of QA for the Business Unit; Serves as the liaison for the Trial Oversight Business Unit
- Responsible for the application of Quality Improvements within the Trial Oversight Business Unit
- Interfaces with the Operational and Strategic arms of Quality Management to obtain and disseminate inputs from the aforementioned teams to facilitate the definition and execution of quality strategies that will result in world class Trial Oversight products and solutions.
- Defines Quality Objectives for the Business Unit and Monitors and Measures Quality; Evaluates current methods.
- Works with Contracts/Business Development; Completes RFIs, RFPs, Quality Agreements, etc.
- Refines/revises Quality Policies for the Business Unit; Generates Quality References/Materials
- Defines Site Specific regulatory requirements for the Trial Oversight Business Unit; LQRs, BCPs, etc. to ensure compliance with local and international regulations.
- Responsible for training and education of Quality Objectives across all QA Business Units and within their individual Business Unit.
- Works closely with project, product, platform team members to make sure that applicable privacy and security requirements are incorporated in standard operating procedures and other controls implemented for a project, product or platform.
- The Director is responsible for the routine reporting of performance metrics related to the Quality of the business unit. This includes regulatory, notifying body, Internal, External, Vendor audit metrics related to Trial Oversight and well as training metrics.
Other Duties and Responsibilities:
- Manage, direct, deliver, or ensure delivery of privacy training and orientation to all employees, volunteers, medical and professional staff and applicable business associates.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
Qualifications and Skills Needed:
- Minimum 5-7 years relevant experience in Trial Oversight.
- Bachelor’s Degree or equivalent experience
- Strong knowledge of EU General Data Protection Regulation (GDPR) on the protection of individuals with regard to the processing of personal data and on the free movement of such data; EU Model Clauses
- Strong knowledge of HIPAA and other privacy and security laws, regulations, and corresponding practices
- General knowledge of global compliance requirements related to global geographic area – US, EU, APAC, etc.
- Formal education or professional experience in law, privacy, public policy, or health care; Pharmaceutical/Clinical Trial experience preferred.
- Experience working in environments that process personally identifiable information (PII) or protected health information (PHI)
- Experience establishing and maintaining privacy and security compliance in a health-related setting
- Excellent organizational, interpersonal, verbal, and written communication skills
- Ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully achieve explicit delivery dates and milestones
ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.