Clinical Quality Assurance Manager

Job title:

Clinical Quality Assurance Manager

Company:

Adecco

Job description

Adecco Italia Spa_Life Science is looking for a “Clinical Quality Assurance Manager”in preparation for the expansion of clinical activities, plans to strengthen the office of clinical quality assurance.The position will be responsible to assess compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols.This position will collaborate with other functions in the Clinical Department.Responsibilities:

• Maintain GCP/ICH compliant systems and processes to ensure the quality of work and clinical trials conducted in Europe and the US.
• Write and/or review clinical SOPs and support continuous process improvements.
• Manage staff training on company procedures, GCP regulations, and documentation systems.
• Qualify CROs and other vendors related to clinical activities.
• Perform documentation control in the TMF and quality reviews of essential clinical trial documents.
• Conduct routine internal system and TMF audits and checks throughout the trial/program lifecycle to ensure compliance with internal procedures and regulatory guidelines.
• Report significant clinical quality deficiencies and/or risks to upper management and actively participate in resolving issues.
• Perform clinical site GCP auditing activities to ensure studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
• Lead the preparation of the company and clinical sites for customer audits and regulatory GCP inspections. Participate as a Subject Matter Expert during regulatory GCP inspections.

Ideal Candidate Requirements:

• Strong scientific background (preferably Master/PhD in Biology, Biotechnology, Life Sciences, etc.).
• Ideally 3-5 years of experience in Clinical Quality oversight (clinical QA experience in the pharmaceutical industry required).
• Complete understanding and application of principles, concepts, and practices of clinical research procedures.
• High level of English proficiency, both written and spoken.
• High attention to detail.
• Ability to work independently, prioritize tasks, and coordinate other team members.
• Excellent interpersonal skills, flexibility in changing tasks and priorities, and motivation for new challenges.

Expected contract type: permanent.Esperienze lavorative:
Clinical Project Manager – Settore industriale: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA – 36 mesi
Quality Control Manager settore farmaceutico – Settore industriale: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA – 36 mesiLingue conosciute:
Inglese: Comprensione OttimoDisponibilità oraria: Totale disponibilitàMoreInformation×QA.Application.SubmittedQA.Thank.ApplyQA.Keep.TrackCondividi questa pagina suI candidati, nel rispetto del D.lgs. 198/2006, D.lgs 215/2003 e D.lgs 216/2003, sono invitati a leggere consultabile sotto il form di richiesta dati della pagina di candidatura (Regolamento UE n. 2016/679).ATTENZIONE: Abbiamo rilevato la presenza in rete di molti annunci falsi; prendi visione dei nostri consigli per riconoscere i tentativi di truffa sulla pagina dedicata al phishing su adecco.it .Adecco Italia S.p.A. (Aut. Min. Prot. N.1100-SG del 26.11.2004).

Expected salary

Location

Milano

Job date

Thu, 20 Feb 2025 23:03:17 GMT

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