Quality Manager, Sponsor Dedicated

hace 1 semana

Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

Location: Argentina

Full Home-based role - Sponsor Dedicated

Job Overview

The Quality Manager provides services within the assigned country/countries or region that ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality functions, and ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures. Further, services/deliverables may include execution of various QC checks, Quarterly Quality Reviews (QQR), audit and inspection support, CAPA support, local SOP management, new hire onboarding/training, SOP/GCP consultation, country regulatory intelligence, local vendor management, and support of Local Operating Company (LOC) Management Reviews. Regularly partners with all local GCO, Medical Affairs Operations (MAO) and Business Quality (BQ) staff as well as Bioresearch Quality and Compliance (BRQC) and Regulatory Compliance to ensure overall country inspection readiness as well as alignment on associated risks and mitigations.

Job Responsibilities

  • Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, etc. and may vary depending on the needs of the hiring department.

  • Complies with relevant training requirements.

  • Quality and Compliance Oversight .

  • Collaborate with Business Quality to support LOC Management Review and local supplier assessments, as appropriate.

  • Autonomy in execution of Regional/Local (Country) Compliance services.

  • Depth of knowledge with Regional/Local Compliance services.

  • Provide mentoring to less experienced Compliance staff.

Requirements

  • BS degree in a health or science related field or 6-8 years relevant experiences equivalent.

  • 6 years previous pharmaceutical industry experience with 3-4 years GXP experience.

  • knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.

  • Advanced English level

  • Good organizational, interpersonal and communication skills.

  • Good judgement and decision-making skills.

  • Strong influencing and negotiation skills.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

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