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
Compliance Lead (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in Basel region
Branche: Sonstige Überlassung von Arbeitskräften
Ihre Aufgaben:
- Provide assessment of CTMP activities and documentation to assure compliance with the CTMP processes, Business, Legal and Regulatory Requirements through the review of records and systems at critical phases and recommends process and training improvements based on findings
- Responsible for the tracking of compliance metrics, regarding the health of CTMP, proactively identifies areas of concern, recommends and support implementation of improvement initiatives in response
- Support TS compliance and process improvement initiatives
- Help coordinate input from other TS clinical functions as required
- Participates in the analysis and communication of significant Quality System events and assists in the preparation and execution of recommended actions to the CS&I/TM leadership team
- Represent TS in relevant cross-functional working groups as required
- In partnership with Global Quality Assurance group, support the development of on-going quality assessments and self-inspections. Responsible for implementation and tracking of related CAPA's and commitments
- Ensures that relevant associates have completed all required training on clinical trial management processes from study start up to study closure including TS protocol development in the appropriate time frame
- Track compliance with required training and other regulatory compliance (i.e., code of conduct, SOPs, GCP), manage feedback, provides updates to functional managers and ensure remedial training is undertaken by individuals and/or groups as needed
- Works with CQA regarding inspection preparation, inspection conduct and follow up during HA inspections. Takes responsibility for with preparation of assigned CAPA's and follow up of issues identified in CQA Audit. - Mainly linked to a specific region e.g. EU / US
- Maintain knowledge of compliance / quality and process improvement methodologies and best practices and share lessons learned across the clinical functions in TS
- Track and report the Quality and Compliance Key Performance Indicators that will be part of the roll-out of QC&SP
Ihre Qualifikation
- Track compliance for CS&I / TM
- Ensure CAPA activities are implemented
- Support / oversee process improvement initiatives to completion within set timelines and budget
Skills:
- Project Management Pharma
Keywords: Compliance