Project Quality Management Specialist, Technology

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