Process Validation Manager - Copenhagen

Vacancy information

Publication date:	December 18 2020
Employment type:	Permanent
Sector:	Biotechnical
Function Group:	Quality/RA

Function Group: Quality/RA / Validation Manager

Organization

For a contract development organisation in the biopharma industry with a global focus and rapid growth, we are looking for a Process Validation Manager. The organisation has a flat hierarchy and allows you to implement your own way of working in your daily tasks. Since the organisation works solely for external clients, no day is the same, therefore being open to flexibility in this ever-changing organisation is an absolute must.

Function

You will be contributing to the growth of the process transfer department in Copenhagen. The process transfer department consists of 3 teams of scientists; upstream process transfer, downstream process transfer, and process validation. In this role, you will be heading the process validation team of eight scientists. Next to heading the team and making sure that the authority guidelines are being followed, you will be responsible for setting the strategy for the process validation of several late-stage biopharmaceutical programs.

Requirements

In order to succeed in this challenge we are looking for someone with the following requirements:

A Master or PhD degree in life science, engineering or similar
A minimum of 5 years experience within validation process in a life science company
Leadership experience or strong potential
Ability to effectively communicate with others engaging with customers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders
Knowledge of EMA, FDA, and ICH regulations for biologics
Quality by design methodology knowhow is a plus
A strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritise between many different tasks

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Hans Dijkstra
Country Director Nordics & Managing Partner

+45 89 88 26 70
h.dijkstra@qtcrecruitment.com

Apply