Poland - Clinical FSP Quality Manager

151.2k - 374.1k PLN151 200 - 374 100 PLN/ rok./ rok.

SeniorOn-site·WarszawaFull-time

#477073·Dodano 5 dni temu·1

Źródło: IQVIA

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Tech Stack / Keywords

GCPICHSOPsKPIsCRO

Podsumowanie oferty

An individual-contributor role supporting clinical quality management for assigned delivery units, sponsors, and business lines. You will help implement quality plans, assess risks, and support compliance with GCP, ICH, and SOPs.

Wymagania

Bachelor's degree or equivalent qualification.
At least 7 years of overall work experience.
At least 3 years of extensive work experience in a GCP environment.
Knowledge of national and international regulations and drug development processes.
Knowledge of CRO or pharmaceutical industry operations.
Good organizational, interpersonal, and communication skills.
Excellent problem-solving skills.
Ability to lead and motivate a clinical team.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients or customers.
Fluent in English.

Obowiązki

Implement the global Quality Management Plan within the assignment, including planning and carrying out quality activities, identifying and assessing risks, supporting mitigation and corrective/preventive actions, and guiding improvements.
Cooperate with business stakeholders to maintain a focus on quality in project delivery.
Contribute to Delivery Unit- or Sponsor-specific Quality Management plans and Risk Management Programs, and monitor their implementation and delivery.
Advise and support teams and stakeholders on GCP compliance.
Work with teams to manage non-compliance and quality issues and support corrective/preventive actions under applicable SOPs.
Inform Quality Management, the assigned business line, and Quality Assurance of quality issues under applicable SOPs.
Work with Quality Assurance and business staff in cases of suspected misconduct, as required by applicable SOPs.
Assist teams during audits and regulatory inspections, as agreed with the business lines and required by applicable SOPs.
Act as the primary contact for Quality Assurance on quality matters for the assignment and attend meetings or teleconferences.
Prepare periodic reports for business lines on quality matters, risk assessments, and quality improvement initiatives.
Perform other reasonable tasks required by the role, as agreed with the line manager.

Benefity

Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to health and welfare or other benefits.

Premie

Inne informacje

Ability to travel within the region or country.

IQVIA

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