Clinical Compliance

ID1030

Senior Consultant Management and Compliance

B.Sc. Clinical Chemistry
Available for: Full time, part time, tasks

Competences

  • Project Management

  • Quality Management

  • Medical Device

  • People leadership and management

  • Process mapping

  • cGMP

  • Performance management

  • Change Management

Key results

Project Management as responsible person for implementation of large projects. E.g., construction and implementation of a pharmaceutical production site. Or as member of top management responsible for the PMO in Biogen.
Change Management leading people towards major changes with success e.g., Implementation of LEAN leadership in several sites in Novo Nordisk.
QMS and Technical File writing and updating QMS for LEO Pharma to fit a changed organization.
Significant leadership skills leading teams and departments over the years in both quality control, aseptic production, and in-vitro production

Standards

  • MDR 2017/645

  • MDD 93/42/EC

  • ISO13485

  • ISO14971

  • FDA regulation [CFR part 820]

  • cGMP

Personal Characteristics

She is a competent leader, who takes responsibility for the people and the tasks from bottom to top.

She is a go-doer and has a no-nonsense attitude always finding a positive and constructive solution to a problem.

She is an experienced consultant and is highly appreciated by her clients.

Privately she enjoys reading books, watching films and theatre, listening to concerts and records, and off course being a grandmother having fun with both dolls and LEGO.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com