Business Analyst 5

You will be responsible for overseeing and coordinating the Quality Assurance (QA) program to support customer accounts, operational teams, audit and inspection programs, and the quality management system (QMS) for the Digital Products and Solutions (DP&S) organization. Your role will involve providing guidance, interpretation, support, and training to delivery and development groups on regulations, guidelines, corporate standards, and policies. You will also be involved in documentation, reporting, investigation, and closure of compliance issues such as deviations, quality issues, CAPAs, and audit findings. Additionally, you will organize and deliver training to other departments on Quality services, quality initiatives, and regulatory compliance. It will be your responsibility to evaluate policies, procedures, and system requirements for compliance with regulations and provide recommendations for continuous process improvements. You will serve as an author and/or independent reviewer of Quality Assurance Standard Operating Procedures (SOPs) and advise Quality Assurance leadership on the governance of DP&S offerings from a QA and regulatory compliance perspective. Your role will also involve maintaining the Quality Assurance database, hosting customer audits, mock regulatory inspections, and regulatory facility inspections as needed. To qualify for this position, you should have a Bachelor's Degree and at least 7 years of Quality Assurance experience in pharmaceutical, technical, or related areas. You should have extensive knowledge of pharmaceutical research and development processes, SDLC, regulatory environments, and current GXP regulations and guidelines. Strong interpersonal skills, problem-solving abilities, risk analysis, negotiation skills, and exceptional training capabilities are essential for this role. Effective organization, communication, team orientation, and leadership skills are required, along with the ability to work independently, manage multiple projects successfully, and establish effective working relationships with coworkers, managers, and clients. Your role will play a crucial part in ensuring compliance, quality, and continuous improvement initiatives within the DP&S organization.,