ninni stenberg

senior consultant and owner

About

I am an experienced and committed leader with a solid background in the Management- and IT-consultant industry. My expertise is within project and quality management, compliance and governance with experience primarily from pharmaceutical, medical device and biotechnology companies. As a co-worker I am social, independent, efficient, deliver with a strong record of high quality and enjoy really making things happen. My leadership is characterized by genuine curiosity, integrity, structure and an aim to always improve!

Country

sweden

City

stockholm

Industry

information technology and services

Skill

quality assurance, gxp, scrum, computer system validation, change management, it management, testing, validation, project portfolio management, service management, software documentation, business process, business analysis, quality management, document management, project delivery, business process improvement, itil, it strategy

Experience

board member

knowit uppsala

2011-5 - 2014-4 · 3 yrs

Board member of the sister company Knowit Uppsala. Knowit Uppsala operated largely within the local Life Science-industry.

senior consultant

medinit ab

2005-3 - 2006-12 · 1 yr 10 mos

Consultant within Project Management and Quality & Compliance Management in regulated companies in the Life Science industry. Examples of assignment: Regulatory Compliance Officer responsible to assure that a global outsourcing contract resulted in a delivery to the pharmaceutical company AstraZeneca that met regulatory requirements. This included e.g. hosting annual audits, leading periodic self-assessments and reviews, managing and reporting on compliance-related incidents, status, KPIs, improvement plans as well as conducting compliance training.

senior consultant and owner

pinetrail consulting ab

2016-9 - Present · 10 yrs 1 mo

Senior consultant with focus on business development, management and governance, often with a link to IS/IT. Typical assignments include project and program management, quality and test management as well as quality reviews and inspections.

manager - compliance and governance

knowit

2011-5 - 2014-4 · 3 yrs

Head of the business area focusing on Quality & Compliance Management and part of the management team of Knowit Business Consulting. The business area included around 15 specialised senior consultants and the role included responsibility for e.g. strategy, business development, economy, planning, recruitment and staff development for the business area.

consultant

prevas ab

1999-8 - 2005-3 · 5 yrs 8 mos

* Consultant within system development and project management in the Life Science industry. Examples of assignments: * Reviewer and Test Lead in 2004 with responsibility for quality management in an analysis algorithm development group, and responsibility for a system test group within a development project in a biotechnology company (Global Genomics AB) * Test Lead and System Developer in a biotechnology company (Alpha Helix AB) in 2003 * Project Manager and System Developer for analysis-algorithm development and testing in a biotechnology company (Pyrosequencing AB)

master thesis student

pharmacia & upjohn

1999-1 - 1999-6 · 6 mos

Exam Project: Establishment of inducible expression systems in mammalian cells and analysis of these with quantitative RT-PCR and Western Blot.

senior consultant

knowit

2005-3 - 2011-5 · 6 yrs 3 mos

Management consultant within the business area focusing on Quality & Compliance Management. Assignments include e.g. project-, quality- and test management as well as audits within regulated companies in the Life Science industry. Examples of assignments: Test Lead within a project to develop processes and systems for management of stability studies for the pharmaceutical company AstraZeneca. Validation Lead within a project to introduce global Service Management processes and system (Remedy) based on ITIL, common for the pharmaceutical company AstraZeneca and its outsourcing partner IBM. Regulatory Compliance Officer responsible to assure that a global outsourcing contract resulted in a delivery to the pharmaceutical company AstraZeneca that met regulatory requirements. This included e.g. hosting annual audits, leading periodic self-assessments and reviews, managing and reporting on compliance-related incidents, status, KPIs, improvement plans as well as conducting compliance training.