Job Description

Summary Coordinate, Control quality and validation efforts, assist in developing a quality/validation strategy, verify activities through reports, write/review/approve system documentation, ensure compliance with policies and procedures, interface with management and stakeholders, guide project teams from a quality perspective, demonstrate the value of quality products and services, train and coach teams, and drive process improvement in the quality area.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.
• 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 xe2x80x9cfit-for-purposexe2x80x9d or xe2x80x9cleanxe2x80x9d approaches.

Ideal Background

• 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.
• 3-6 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 3 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 information security tasks and monitor their implementation during assigned projects.
• Software Development Methodologies: Agile (must have), Dev / SecOPs (good to have)
• Quality and Process Management (CMMI, Six Sigma, good to have)
• Performs a range of work, sometimes complex and non-routine, in a variety of environments.
• Applies methodical approach to issue definition and resolution.
• Has a sound generic, domain and specialist knowledge necessary to perform effectively in the organization typically gained from recognized bodies of knowledge and organizational information?

Other skills

• Demonstrates effective application of knowledge.
• Has an appreciation of the wider business context?
• Plans, schedules, and monitors own work (and that of others where applicable) competently within limited deadlines and according to relevant legislation, standards, and procedures.
• Contributes fully to the work of teams.
• Demonstrates an analytical and systematic approach to issue resolution.
• Takes the initiative in identifying and negotiating appropriate personal development opportunities.
• Understands how own role impacts security and demonstrates routine security practice and knowledge required for own work.
• Communicates effectively, fluently both orally and in writing. Can present complex information to both technical and non-technical audiences

Skills Desired Communication Skills, Compliance Audits, Compliance Management, Compliance Risk Assessment, Compliance Training, Influencing Skills, Quality Assurance

Novartis