Interim Head Quality Affairs/Regulatory Affairs (gn)

To date, our client has been a key partner in more than 120 drug development and manufacturing projects across all therapeutic areas, including several that have become commercialized therapeutics.

 

To support the location in Switzerland, we are looking for a

Interim Head Quality Affairs/Regulatory Affairs (gn)

  • Bereich:

    Medical

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    Muttenz - Schweiz

  • Art der Anstellung:

    interim

  • Kennziffer:

    26703

  • Aktualisierung:

    2021-06-24

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Your tasks

The Head QA/RA is accountable for ensuring that GMP requirements, Pharmaceutical statutory/regulatory requirements and internal quality requirements are fulfilled and that independence from operations with respect to the release of batches is maintained.

 

  • Proactively participates as member of Leadership team in defining the vision, creating the strategy and setting the functional objectives 
  • Assures adequate staffing in the department (knowledge, skills, resources)
  • Advises the leadership on short / long term Quality objectives and performance targets
  • Sets objectives & performance targets for the Quality Assurance Department
  • Ensures compliance of departmental activity with relevant external regulations and internal policies, procedures and standards in all areas of operations
  • Handles complaints and recalls according to the Corporate Quality Manual
  • Develops and manages the Quality performance reporting system and provide collated performance data to managers to identify trends or emerging issues. Ensure that incidents are reported and investigated, corrective actions are taken including lessons learned
  • Responsible for developing and managing the Internal Quality Inspection & Audit program
  • Ensures that Quality Improvement Plans are developed and monitored in order to meet performance targets or to continuously deliver improved Quality performance
  • Promotes a culture in the site that respects Quality and takes decisive and appropriate action if operating standards are not met

Your qualifications

  • Chemical Engineer or Ph.D. in Organic Chemistry
  • cGMP qualified person responsible under Swiss law
  • At 15 years experiences as QA leader of an API/CDMO company
  • Advanced knowledge of Quality Management Systems, cGMP & regulatory requirements, Quality auditing, Quality risk assessment, Incident investigation and root cause analysis
  • Positive mindset and ability to adapt to fast paced growing start up environment
  • Ability to motivate and lead a diverse team
  • Good communication and negotiation skills
  • Analytical ability, structured and efficient working style
  • Business proficient in German and fluent in English is a must

Your contact person

Bettina Cöppicus
Senior Personalberaterin

Address

Optares ICM GmbH & Co. KG
Bettina Cöppicus
Heiligengeist Höfe 8
26121 Oldenburg