Beschreibung
On behalf of a major Pharma client, we are urgently looking for a Franchise Operational QA Manager for a role starting ASAP for approx. 6 months (with extension option). You will be a member of the Pharma Development Quality Assurance team and provide Quality and Compliance Guidance for the development and implementation of Corrective and Preventive Actions (CAPA); monitor their status and timely closure; and also ensure an adequate Regulatory inspection and Audits preparation.
Your Main Tasks:
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, guide-lines, 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. Required Skills and Background: Degree or PhD in Life Sciences, Pharmacy or Medicines Fluency in English (oral and written) Ten (10) plus years of experience in Clinical Development and Pharma industry Preferably at least 3 years in Quality Assurance/Compliance roles Thorough & 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 & computer skills Excellent problem solving and decision making skills; conflict resolution/negotiation 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 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. Are you available immediately or very soon and do you offer this skills set? If you are interested to work for a great name in Switzerland please do not hesitate to send me your very detailed and updated English CV (MS Word file please) and references or contact me. Please make sure your CV shows your deep expertise in this variety of areas and qualify your experience in years - thank you! Looking forward to receiving your application - thank you!
