Senior Clinical Quality & GCP Manager

IQVIA Inc

Województwo mazowieckie

Presencial

PLN 151.000 - 374.000

Jornada completa

hace 44 horas
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Descripción de la vacante

IQVIA Inc. is seeking a quality management professional to lead and support quality control and risk management across designated delivery units and teams.

You will ensure adherence to GCP, SOPs, and regulatory standards while guiding staff and stakeholders toward continuous improvement. This role emphasizes collaboration with global and regional Quality Management teams, risk assessment through data review, and preparation of periodic quality reports.

Formación

  • Bachelor's Degree or equivalent qualification.
  • At least 7 years of overall working experience.
  • At least 3 years of extensive working experience in Good Clinical Practice (GCP).
  • Knowledge of National and International Regulations and Drug Development processes.
  • Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
  • Good organizational, interpersonal and communication skills.
  • Ability to travel within the region/country.
  • Ability to lead and motivate a clinical team.
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
  • Fluent in English.

Responsabilidades

  • Adopt and implement the global Quality Management Plan within the scope of the assignment, including planning and executing the Quality Management activities, risk identification and assessment, and guidance for improvement.
  • Cooperate closely with relevant business and stakeholders to maintain focus on quality in project delivery.
  • Develop and implement a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor implementation and delivery.
  • Provide advice and support to teams on all aspects of GCP compliance.
  • Work with teams to manage non-compliance and quality issues, planning corrective/preventive actions.
  • Inform Quality Management and stakeholders of quality issues according to SOPs.
  • Collaborate with Quality Assurance during audits and inspections as required.
  • Act as primary contact for Quality Assurance at the assignment level.

Conocimientos

Fluent English
GCP knowledge
Regulatory knowledge
Travel ability

Educación

Bachelor's Degree or equivalent

Descripción del empleo

IQVIA Inc. is seeking a quality management professional to lead and support quality control and risk management across designated delivery units and teams.

You will ensure adherence to GCP, SOPs, and regulatory standards while guiding staff and stakeholders toward continuous improvement. This role emphasizes collaboration with global and regional Quality Management teams, risk assessment through data review, and preparation of periodic quality reports.

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