Join Our Team

Role

Internal Audit Global Quality Associate - (Ewing Township, NJ)

Responsibilities

Developing and implementing a global Quality Management System (“QMS”) to ensure regulatory compliance within organizational processes. Developing and implementing Quality Management Development planning tools and the QMS roadmap, including prioritization of creation of Controlled Quality Documents (e.g., Standard Operating Procedures) for company’s core processes including Quality Processes. Assessing and monitoring the regulatory efficacy of the local site’s implementation of proprietary Controlled Quality Documents. Assessing the annual Quality Audit Plan and managing the execution of the plan. Developing and overseeing NDA’s database for global quality subcontractors and vendors. Analyzing audit results to determine methods for increasing regulatory and decreasing unnecessary gaps. Developing a proprietary audit process and program for NDA that is used internally and externally with clients. Analyzing the quality and regulatory processes of NDA, identifying risks within our business practices, and evaluating the controls put in place to counter them. Preparing reports and presenting summarized findings concerning audit results and trends for internal groups. Planning and coordinating the Quality Management Review meetings. Performing and coordinating client work for European and U.S. clients, providing advice on regulatory and quality laws and regulations from European Medicines Agency (EMA), national competent authorities, and the U.S. Food and Drug Administration (FDA).

Requirements: 

• Master’s degree in health sciences, pharmaceutical sciences, public health, or a related field. and two years of experience in quality assurance and auditing in pharmaceuticals, medical devices, or a related industry.
• Proficiency in agile development methodology.
• Knowledge of European Pharmaceutical Regulations (European Medicines Agency (EMA) and National Competent Authorities).
• Knowledge of FDA pharmaceutical regulations.
• Experience communicating with European and U.S. health authorities, including the Food and Drug Administration
• Experience in hosting regulatory inspections and responding to findings.
• Proficiency in GMP and GDP compliance and training programs, and QMS monitoring and development.
• Experience utilizing quality tools including auditing systems and programs, Deviation, CAPA investigation and management system, and change management system.
• Experience guiding internal and client organizations on quality issues and interpretation of related standards.
• Experience with Electronic Document Management System (EDMS) and NIST Database (3). Functional knowledge of marketing decision-making and research processes including survey methodology and sample selection.

As a person you are proactive, collaborative, adaptable and confident in decision-making. You enjoy networking and contribute actively to business expansion.

Become a part of NDA’s growing, highly qualified team!

Application & Contact

Resumes and queries: NDA Regulatory Development Inc. recruitment@ndareg.com. Please add email Subject: Attention to Erica Lindewald, VP Global People & Culture.

Selection of candidates & interviews will be conducted continuously so please submit your application as soon as possible. 

Related information

• Our Mission
• NDA Brand Book