Associate Principal Quality Analyst, Quality, Process & Training

Job Description

As the Associate Principal Quality Analyst, Quality, Process & Training, you will support regulatory compliance and quality related activities including investigation and resolution of study level quality issues, CAPAs and ECs across ADS. You will also support process development and improvement, risk assessment, creation and monitoring of KQIs, KPIs, trending of CAPAs, investigation of potential Serious Breaches, functional inspection readiness, and internal and external process and vendor audits. You will manage end-to-end quality deliverables across ADS and ensure that the ADS responsibilities and accountabilities within the Quality Management System (QMS) are supported within ADS.

• Provide guidance and support to ADS staff on quality and process concerns, regulatory compliance, and best practices. Serve as a liaison between ADS and R&D Quality and Compliance, Business Process Excellence and R&D Learning as needed.
• Support process owners, SMEs, and cross-functional teams in revision of existing processes or development of new processes. Ensure that all process maps and controlled and uncontrolled documents meet departmental standards and are kept up to date.
• Facilitate ADS-related internal and external audits and inspections. Provide leadership, training, and support to ADS inspection teams.
• Support work of Process Analysts and Technical Writers on development, review and updates to ADS controlled and business processes.
• Conduct Business Process Compliance Reviews in support of process improvement
• Ensure that training materials and assignments support all processes and adjust as needed to ensure compliance.
• Support larger quality investigations done by quality team, including understanding of root cause, discussion with key stakeholders and process owners and conduct of CAPA Effectiveness Checks after larger quality issues are closed

You are a Principal Quality Analyst who can develop root cause analysis for quality issue and consult on regulations and best practices for process development. You can determine if quality issues require a CAPA. You have a high attention to detail including proven ability to manage multiple, competing priorities.

Qualifications

• Bachelor’s degree required; Master’s degree preferred
• 7+ years relevant work experience in a related position(s) with a focus on Data Management, Statistics or Statistical Programming
• Detailed knowledge of Data Management, Biostatics, and Statistical Programming processes.
• Experience developing processes and writing controlled documents
• Solid understanding of drug development and biopharmaceutical industry
• Knowledge of GCP and other regulations

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

All your information will be kept confidential according to EEO guidelines.