Beschreibung
Reference Nr: 9739TG
Industry: Pharma
Location: Basel
Start: ASAP
Duration: 6 Monate +
Introduction:
For one of our clients in Basel we are looking for an experienced Operational Quality Manager to support our clients 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 regulator y inspection and audits preparation.
Role:
1. Guide development teams in quality and compliance decision making to
drive sustainable quality and compliance excellence
2. Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA)
3. Coordinate and review CAPAs to audits to ensure adequate root cause analysis and systemic solutions
4. Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course
5. 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
6. Represent Franchise QA in interactions with internal and external contacts and Health Authorities, as appropriate
7. 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
8. Ensure that Franchise compliance commitments are fulfilled on time
9. Provide interpretation of GCP regulations and company standards, guidelines, policies and procedures to Franchise personnel
10. Drive the implementation of the annual Franchise Quality Plan; identify relevant areas to be addressed in future Quality Plans
11. Closely cooperate with the Franchise Continuous Improvement/Op Excellence groups; participate and provide Quality and Compliance input for process improvement teams
12. 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
Requirements:
Education and certificates
Degree or PhD in Life Sciences, Pharmacy or Medicines
Experience
10+ years of experience in clinical development and the pharmaceutical industry preferably with at least 3 years in Quality Assurance/Compliance roles
Responsibilities
- Thorough and extensive knowledge of inter-national 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
- Excellent problem solving and decision making skills. Skilled at conflict resolution/nego-tiation.
- 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.
- Flexibility to react to changing priorities in a dynamic business environment
- Considerable organization awareness (eg interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
Language: Fluency in English (oral and written)