Franchise Operational QA Manager – Switzerland

Priya Mukherjee at CK Clinical is currently recruiting for a Franchise Operational Manager to join a global pharmaceutical company based in Switzerland on a contract basis.

 

The Role:

As Franchise Operational QA Manager you will support Franchise Development Project Teams with adequate quality and compliance guidance; Provide quality and compliance guidance for the development and implementation of corrective and preventive actions; monitor their status and timely closure and ensure adequate regulatory inspection and audits preparation.

Further responsibilities of this Franchise Operational QA Manager position will include:

  • Guide development teams in quality and compliance decision making to drive sustainable quality and compliance excellence
  • Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA)
  • Coordinate and review CAPAs to audits to ensure adequate root cause analysis and systemic solutions
  • Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course
  • Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures through partnership with Franchise personnel, Development Line Functions and Development QA groups
  • Represent Franchise QA in interactions with internal and external contacts and Health Authorities, as appropriate
  • Ensure inspection readiness by preparing clinical teams for FDA/EU/key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspection
  • Ensure that Franchise compliance commitments are fulfilled on time
  • Provide interpretation of GCP regulations and company standards , guidelines, policies and procedures to Franchise personnel
  • Drive the implementation of the annual Franchise Quality Plan; identify relevant areas to be addressed in future Quality Plans
  • Closely cooperate with the Franchise Continuous Improvement/Op Excellence groups; participate and provide Quality and Compliance input for process improvement teams
  • Closely cooperate with the Development QA Quality Systems Excellence, Auditing and Compliance Excellence groups to ensure consistency of quality and compliance activities and effective communication

 

Qualifications, Skills and Experience:

To be considered for this Franchise Operational QA Manager position, you will have the following qualifications, skills and experience:

  • A degree or PhD in Life Sciences, Pharmacy or Medicines (Or Equivalent)
  • Proven experience in clinical development and the pharmaceutical industry preferably with experience in Quality Assurance/ Compliance roles
  • Thorough and extensive knowledge of international GCP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice;
  • Excellent verbal and written communication skills, computer skills and excellent problem solving and decision making skills.
  • Capable of working independently as well as part of a cross-functional team demonstrating the ability to influence and create alignment across multiple functional areas together with the flexibility to react to changing priorities in a dynamic business environment.

 

How to Apply:

 

Priya Mukherjee is recruiting for a Franchise Operational QA Manager – Switzerland

Contact Priya for more details.

Click here to apply for this position now.

 

For more information regarding this Franchise Operational QA Manager position please contact Priya Mukherjee at CK Clinical on +44 (0)207 470 5670 or email pmukherjee@ckclinical.co.uk. Please quote reference CL24817 in all correspondence.

 

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