Project Quality Management Sr Specialist-4

21 hours ago

Telangana Sandoz, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Description Summary

-Supports the implementation of the information security. governance and strategy per the information management framework through business partnering

Job 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

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