Leads the development of regulatory and quality management system architectures in specific business, infrastructure or functional areas. Ensures that appropriate tools and methods are available, understood and employed in architecture development.
Within a change programme, leads the preparation of technical plans and, in liaison with business assurance and project staff, ensures that appropriate technical resources are made available.
Provides advice on technical aspects of solution development and integration (including requests for changes, deviations from specifications, etc.) and ensures that relevant technical strategies, policies, standards and practices (including security) are applied correctly.
Defines systems development projects which support the organisation's objectives and plans.
Takes full responsibility for business analysis within the regulatory and quality application segment of the organisation where the advice given, and decisions made will have a measurable impact on the profitability or effectiveness of the organisation.
Leads the selection of appropriate business analysis methods, tools, techniques; selecting appropriately from plan-driven/predictive approaches or more adaptive (iterative and agile) approaches.
Establishes the contribution that regulatory and quality technology can make to business objectives, defining strategies, validating and justifying business needs, conducting feasibility studies, producing high-level and detailed business models, preparing business cases, overseeing development and implementation of solutions, taking into account the implications of change on the organisation and all stakeholders.
Guides senior management towards accepting change brought about through process and organisational change.
Education:
Matric / Grade 12
B.Com / BSc Computer Science degree or equivalent work experience
Experience:
10+ years' experience of managing relationships with internal business customers
10+ years' experience managing customer relationships in an operational and global services and automation in a large complex/matrix global organisation
10+ years' experience leading and influencing customers and matching needs to solutions
Experience and sound knowledge of business processes, quality management and auditing and assurance practices and improvement practices
Proven experience working in a pharma regulated environment with application of computer system validation
Certifications:
Current industry certification in architecture (i.e., TOGAF, GxP, ISO 9000)
Business Process Management Methodology (i.e., BPM, SDLC, ITIL, DevOps, Agile, COBIT)
Skills and Attributes:
Visioning
Strategic planning
Global thinking
Entrepreneurial thinking
Teamwork
Initiative
Results oriented
Systems thinking
Focused
Problem-solving and good judgment
Responsibility and accountability
Cooperation
Proactive
Resilience
Active listening skills
Presentation skills
Meeting facilitation
Organisational awareness
Influence skills
Pragmatic
Empathy
Aspen Competencies:
Business:
Accountability/ Ownership
People:
Communicate Effectively
Self:
Take Action with Integrity
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