Business Analyst 5

Job Overview

Oversee & coordinate assigned QA program in support of customer accounts, operational teams, audit and inspection program, or quality management system (QMS) for the Digital Products and Solutions (DP&S) organization. Provide support to leadership with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, and productivity/efficiency continuous improvement initiatives. Manage the quality assurance oversight of projects, product/service offerings, assignments, training and staff.

Essential Functions

" Provide guidance, interpretation, support, training, and key input to delivery and development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.

" Oversee and participate in the documentation, reporting, investigation, and closure of compliance issues (e.g. Deviations, Quality Issues, CAPAs, Audit Findings).

" Organize and deliver training to other *** departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.

" Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.

" Evaluate policies, procedures, and system requirements for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

" Serve as author and/or independent reviewer of Quality Assurance Standard Operating Procedures ( SOPs) as assigned.

" Advise Quality Assurance leadership on the health and governance of DP&S offerings from a QA and regulatory compliance perspective, providing metrics to support as needed.

" Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.

" Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed

Qualifications

" Bachelor's Degree Pref

" 7 years Quality Assurance experience in pharmaceutical, technical, or related area. Equivalent combination of education, training and experience.

" Knowledge of word-processing, spreadsheet, and database applications.

" Extensive knowledge of pharmaceutical research and development processes, SDLC, and regulatory environments.

" Excellent knowledge of current GXP regulations and guidelines, and associated regulatory requirement, including Computerized System regulations.

" Considerable knowledge of quality assurance processes and procedures as applied to technology and service delivery within a regulated environment.

" Extensive experience overseeing and documenting the investigations, Root Cause Analysis, and closure of compliance issues (e.g. Deviations, Quality Issues, CAPAs, Audit Findings).

" Strong interpersonal skills.

" Excellent problem solving, risk analysis and negotiation skills.

" Exceptional training capabilities.

" Effective organization, communication (especially effective writing skills to facilitate high-quality client-facing communication/deliverables), team orientation, and leadership skills.

" Ability to work independently with initiative.

" Ability to manage multiple projects to drive successful outcomes (project management skills).

" Ability to establish and maintain effective working relationships with coworkers, managers and clients.