Global Process Control Manager – PCM

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11504en
  1. Contract
  2. English
  3. Not Applicable*
  4. Research & Development
  5. Basel
  6. Healthcare & Life Sciences

Skills

Clinical Operations, ICH-GCP Process Control, ICH-GCP Quality Assurance systems, Health Authority regulations, SOP, Standard Operating Procedure

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On behalf of our client, a multinational and leading pharmaceutical company, Swisslinx is seeking a highly motivated Global Process Control manager, to join their Trial Monitoring department in Basel.

This is an excellent opportunity to leverage your past skills and knowledge, whilst enjoying a dynamic working environment. Please note that this is a contract position for 1 year (with possibility for extension), starting as soon as possible.

Your Mission:

- In charge of process control and optimisations within Trial Monitoring (TMO)
- Carry out risk management tasks to ensure Good Clinical Practices (GCP)
- Review the GCP audit and suggest mitigations to flaws (lessons learnt)
- Monitor performance (tacking compliance, reporting, and enforcing abidance to KPIs)
- Assist with the creation and execution of quality improvement initiatives that are sustainable, as well set SOPs (standard operating procedure)
- Convey new initiatives to relevant persons within the organisation and keep check of any gaps
- Initiate necessary training where needed to ensure processes and procedures are in line with internal and external standards
- Make sure there are structures in places for reviews and inspections
- Escalation management

Your background:

- University degree in life sciences or related
- Around 4 years of experience in a R&D environment – preferable pharmaceutical or healthcare & life sciences
- Clinical operations experience is highly advantageous
- Knowledge of ICH-GCP Quality Assurance Systems and Health Authority regulations
- Fluent in English (both spoken and writing)

Candidates must have a valid Swiss or European permit or work rights to be considered for this position. If you would like to be considered for the role, please apply directly or send your CV to alexi.donadoni@swisslinx.com

We look forward to hearing from you!

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