CSV Consultant, e-Compliance / IT Governance, QA

OVERVIEW RESPONSIBILITIES:
Responsible for the Computerized Systems Validation (CSV). Support complex technical quality requirements in specific CSV situations, such as validation of new systems, upgrades, changes, or remediation etc. Provide guidance, interpretation, and assure compliance with CSV related regulations, quality manuals, company policies, and procedures.
Develop and manage GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols and Reports (IQ/OQ/PQ), User Acceptance testing, Traceability Matrix, Validation Reports/Validation Summary Reports, SOPs, Change Control Documentation, and Risk Assessment reports.
Conduct system compliance risk assessment. Conduct Data Integrity risk assessment. Support and/or perform all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews. Support enterprise CSV related initiatives and remediation activities including 21 CFR Part 11 compliance.
Experience with new technologies such as artificial intelligence (AI) and machine learning (ML) and be able to lead AI/ML-based CSV activities.
Lead or participate in vendor CSV audits as a subject matter expert (SME).
Balance a multiplicity of demands in a responsive, professional manner to assure e-Compliance team provides appropriate and timely support to meet business objectives.
Perform other related duties and assignments as required.
Cross-functional and Global Team Participation:
• Manage and support project teams with relevant compliance assessments, requirements and test scripts, validation plans/ protocols and reports.
• In close collaboration with QA and functional units (e.g. Biostats and Data Management, Clinical, Regulatory, Pharmacovigilance; etc.) to ensure rigorous execution of computerized system validation QA and/or IT-related activities throughout the development lifecycle, including initial implementation, change management, and decommissioning.
• Deeply understand and expertly support method validation, process validation, equipment validation, and instrument QC/testing in manufacturing plants to ensure GMP compliance of production processes.

Skills:
· Be familiar with the increasing application of new technologies in the pharmaceutical industry, understand the various new compliance guidelines of health authorities regarding AI, and lead the validation of AI-enabled applications/systems.

· In collaboration with the audit team, support the effective communication of observations and recommendations, detailing impact and risks to the organization; including provide leadership in remediation activities.

· In collaboration with other QA organizations, countries/ regionals, foster a culture of information sharing best practices to support high quality clinical trials and data."

Customer Focused/ Stakeholder Engagement:

· Provides quality computerized system validation support during deployment of global solutions and / or systems and ensure global standards / SOPs are in place, effective, meet regulatory expectations and can be implemented.

· Identify and support strategic quality and business initiatives including appropriate remediation programs, quality/compliance activities and affected changes.

· Proactively assess and assign resources as needed to support key project deliverables across QA line functions. Prioritize and ensure value added deliverables are in scope for QA oversight and management.

· Support innovative technologies used in clinical trial studies as well as the transformation of existing clinical trial processes and clinical teams to a digital technology-enabled environment.

Regulatory Inspections and Partner Audits:

· Support of regulatory inspection and partner audit preparation as a SME, management and follow-up in collaboration with business functions, and support local inspections specifically when IT-systems and / or global clinical operations are in scope.

Education:

Bachelor’s degree in scientific or engineering discipline along with 7+ years of experience in the field of computer validation in the Life Sciences (Pharmaceutical, Medical Devices) and Healthcare industries.

· 7+ years’ experience in GxP / QA within FDA regulated environments GAMP 5 with risk-based CSV is required.

· Experience in developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phases.

· Ability to communicate effectively at all levels in the company.

· Exceptional attention to detail, cross-checking, and verifying correctness of data.

· Good interpersonal skills with the ability to interact and influence others to complete mutually agreed tasks per schedule.

· Ability to effectively manage time to meet assigned deadlines and prioritize multiple work assignments.

· Ability to work independently with minimal supervision.

· Excellent Technical Writing skills.

· Computer literate in Microsoft Word, Excel, PowerPoint, and working knowledge of Windows.