Job Description
Position Title :
Project Quality Management Specialist, Technology
About The Role
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
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
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.
