Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Franchises QA Operational Excellence Manager (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM+
Ort: in Basel region
Branche: Sonstige Überlassung von Arbeitskräften
Ihre Aufgaben:
- Manage the implementation and monitoring of key quality indicators (KQI) for the Franchises, including the compilation, analysis and assessment of metrics and KQI across Franchises, and prepare metrics reviews with appropriate granularity for DQLT, Franchise QA leadership and Development Franchises/IFBs
- Support the identification and resolution of potential gaps as well as the identification of process improvement opportunities across the Development Franchises from KQI trends and patterns, and ensure/support their integration into the annual Development QA Quality Plan
- Drive the identification, development and/or selection, and deployment of suitable and operationally efficient KQI platforms/systems, including user training, if required
- Support oversight and tracking of respective follow-up activities (e.g. procedural updates, training, business process improvements, and effectiveness checks) in close collaboration with Franchise QA leadership and the business partners
- Support training needs in the Franchises, and the development of suitable train-ing/instructional materials
- Liaise with all relevant sources of metrics and quality indicators (Training/SOP governance, Compliance Excellence, Chief Medical Office, Commercial, DRA, Data Management etc.), and serve as the point contact and key subject matter expert and resource for the Franchise QA groups
- Efficiently navigate clinical and QA IT tools, e.g., ClinAdmin, CREDI, REDI, QAAD/AQWA, and serve as expert user for the Franchise QA groups
- Support comprehensive, efficient and timely inspection preparation and readiness across Franchises for any relevant Health Authority (FDA/EMA/key HA pre-approval and sponsor-monitor inspections) or GQA inspection. Coordinate preparation activities, provide inspection management support and coordinate post-inspection follow-up
- Identify benchmarks and best practices from other QA groups and line functions in Pharma Development and beyond that can be applicable to Development QA with clear business benefit, and propose/drive their implementation in Development/Franchise QA as appropriate
- Represent the Franchise QA groups in process improvement programs, and provide quality and compliance guidance and expertise to cross-functional continuous im-provement project teams
- Lead QA-sponsored process improvement programs with cross-functional scope
- Ensure and follow execution along agreed project timelines and deliverables, monitor and document progress, identify risks and opportunities, take corrective actions, and escalate as appropriate
- Support Franchise QA leadership in the preparation of strategic docu-ments/presentations for use in Development QA, the Franchises and beyond
Ihre Qualifikation
- Degree or PhD in Life Sciences, Pharmacy or Medicines
- Fluency in English (oral and written)
- Sound experience in clinical devel-opment and the pharmaceutical industry, profound experience in Quality Assurance or Compliance roles
- Excellent verbal and written communication skills, state-of-the-art computer skills
- Excellent problem solving and decision-making skills
- Skilled at conflict resolution and negotiation
- Proven track record of high impact accomplish-ments in a global/matrix environment in the phar-maceutical industry
- Strong project management skills
- Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
- 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
- Sound working knowledge of international GCP regulations including FDA/EU GCP, ICH, pharma-covigilance, new drug regulations, other key HA guidance's, and current industry practice
Skills:
- Project Management Pharma
- Quality Manager Pharma