Clinical FSP Quality Manager

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SeniorHybryda·MunichFull-time

#469725·Dodano 7 dni temu·0

Źródło: IQVIA

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Tech Stack / Keywords

GCPICHISO 14155SOPCROKPI

Podsumowanie oferty

The role supports quality management across assigned delivery units, sponsors, and business lines in clinical research. It includes implementing quality plans, assessing risk, supporting GCP compliance, and addressing quality issues.

Wymagania

At least 3 years of experience in a clinical quality or GCP compliance role.
At least 5 years of experience in medical devices, clinical research, or a related industry.
Strong understanding of ICH GCP and knowledge of ISO 14155.
Knowledge of national and international regulations and drug development processes.
Knowledge of Clinical Research Organization (CRO) or pharmaceutical industry operations.
Excellent problem-solving skills.
Ability to establish and maintain effective working relationships with co-workers, managers, and clients/customers.
Fluent in English.

Nice to have:

GCP audit experience.

Obowiązki

Implement the global Quality Management Plan within the assignment, including planning and executing quality activities, identifying and assessing risks, supporting mitigation and corrective/preventive actions, and guiding improvement.
Cooperate with business stakeholders to maintain 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 planning corrective/preventive actions according to SOPs.
Report quality issues to Quality Management, the assigned business line, and Quality Assurance according to SOPs.
Work with Quality Assurance and assigned business staff on suspected misconduct, as required by applicable SOPs.
Assist teams during audits and regulatory inspections as agreed with business lines and required by applicable SOPs.
Act as the primary contact for Quality Assurance on assignment-level quality matters and attend meetings or teleconferences.
Prepare periodic reports for business lines on quality matters, risk assessments, and quality improvement initiatives.
Perform other reasonable tasks as required by the role, upon agreement with the line manager.

Inne informacje

The role requires attendance at the Brussels office 2–3 times per week.

IQVIA

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