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 fit-for-purpose or lean 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
