Job Description Summary
-Supports the implementation of the information security. governance and strategy per the information management framework through business partneringJob Description
Major Accountabilities
• Accomplish ITQM objectives in the assigned project by planning, executing, and evaluating quality activities (as per service description).
• Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology.
• Lead, Coordinate and control the performance of quality and validation efforts during assigned projects in accordance with specified quality standards.
• Develop a Quality / Validation strategy which defines actions, deliverables, responsibilities, and procedures.
• Verify completeness and correctness of planned qualification / validation activities via a Qualification / Validation Report.
• Write / review / approve system documentation as per applicable standards, compile input from subject matter experts and seek approval from stakeholders.
• Perform reviews to ensure compliance and adherence to corporate and regulatory policies and procedures.
• Successfully interface with all levels of management and customers or suppliers to assure a consistent supply of quality products and services.
• Partners with PM to lead project team from a quality perspective, defend quality approaches towards challengers and mediate quality-related conflicts and negotiate solutions.
• Demonstrate the value of quality products and services to the project team for increased adoption and adherence.
• Train and coach teams on quality aspects of system life-cycle processes, quality standards.
• Be process-driven and continuously strive for process improvement in the quality area. Apply and define "fit-for-purpose" or "lean" approaches.
Education
• Bachelor's Degree (or equivalent) in Computer Science, Information Systems Management, Mathematics, Informatics, or other related fields.
• Certification or accreditation in Information Security (CISM, CISA, CISSP etc.) is a plus.
• Fluent in written and spoken English.
• 6-10 Years of relevant experience in BioPharma IT Quality & Compliance departments
ITQM skills
• Has successfully managed quality during multiple international and/or cross- functional IT projects and/or operations and has a minimum of six years hands-on quality management.
• Expert Knowledge and hands-on working experience of Quality and Security Management in the following areas / disciplines
• GxP, CSV and GAMP
• Good understanding of pharmaceutical validation requirements driven by health authorities like FDA etc.
• IT System Lifecycle (Requirement Management, Design, Testing, Deployment)
• Adequate project management skills to plan quality and infor-mation security tasks and monitor their implementation during as-signed projects.
• Software Development Methodologies: Agile, Dev / SecOPs
• Quality and Process Management (CMMI, Six Sigma)
Skills Desired
Communication Skills, Compliance Audits, Compliance Management, Compliance Risk Assessment, Compliance Training, Influencing Skills, Quality Assurance