Job Description
As part of the Global Laboratory Office, you will closely work together with local PSG site Quality Laboratories to assure compliance, standardized processes at sites along with efficiency improvement, and running laboratories as a business.
This will be achieved by this position leading deployment and maintenance lab productivity initiatives at EU/APAC PSG sites and tracking of related metrics as well as operationally supporting Quality Lab QMS standardization.
Discover Impactful Work:
A day in the Life:
- Define and optimize Quality Laboratory processes and author SOPs based on best practices and following regulatory guidelines to standardize business processes with compliance focus.
- Author, create, and maintain GLO change management concepts and related material, e.g. playbooks, training material, work instructions, communication concept, etc.
- Train global and local colleagues on processes, SOPs, playbooks, etc.
Keys to Success:
Education
- Bachelor’s degree in physical science, preferably Chemistry or Biochemistry. Master’s degree is preferred.
- Operational excellence expertise, e.g. six sigma certification
Experience
- Minimum of 5 years laboratory experience in a GxP setting for pharmaceutical testing of drug products or small, large molecule drug substances and related raw materials.
- Experience on lean labs and operational excellence.
Knowledge, Skills, Abilities
- An understanding of interaction of compliance, productivity and cost efficiency, will therefore be crucial in this role, besides the ability to collaborate with PSG site representatives.
- Program management skills, leading by influence, cross functional teams.
- Confirmed knowledge of and experience with regulatory requirements applicable for biologics and pharmaceuticals to ensure a compliant environment.
- Fluent English communication skills, written and verbal, second language preferred.
- Proficient in group and upwards presentations.
- Ability to work in a collaborative team environment. Ability to conduct training programs.
Physical Requirements / Work Environment
Work independently as part of a global virtual team, and travel up to 25% of your time for deployment purposes and active site support
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!