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.
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:
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 firstname.lastname@example.org. Please quote reference CL24817 in all correspondence.