Senior / QA Project Lead - NA / Europe - Remote

Worldwide Clinical TrialsBarcelona, Cataluña, España

Hace más de 30 días

Descripción del trabajo

Join to apply for the Senior / QA Project Lead - NA / Europe - Remote role at Worldwide Clinical Trials

Overview

We are Worldwide Clinical Trials, a global midsize CRO. Our mission is to improve lives by delivering quality and excellence. We are looking for a Senior / QA Project Lead to join a global team and support QA activities across NA / Europe remotely.

What You Will Do

Collaborate with project team members to ensure compliance with study protocols and regulations.
Act as a GCP Subject Matter Expert (SME), providing GCP consultancy to project teams for assigned projects.
Manage and facilitate investigations and root cause analyses for Quality Issues (QIs), including development of CAPA plans for assigned projects.
Participate in risk management activities.
Proactively identify risks and implement mitigations and controls.
Perform quality assurance review and trending activities for assigned projects.
Provide Clinical Investigator Site inspection and audit support as required.
Provide GCP consultancy and review QMD deviations for project teams.
Collaborate with Therapeutic Area Quality Leads within the QMO team and support QA relationships with Sponsor QA counterparts and quality metrics.
Assist with Sponsor audits and regulatory inspections as assigned.

What You Will Bring To The Role

Professional, concise, clear, and consistent communication for internal and external customers.

Act as a positive QA ambassador during daily activities and customer interactions.

Ability to manage projects / teams of significant scope and complexity with enthusiasm, prioritizing workload to meet deliverables and timelines.

Ability to work independently, take initiative, and adapt to varying tasks.

Sense of urgency and reliability in delivering time-sensitive deliverables.

Strong influencing and negotiation skills.

Your background

Bachelor’s degree or equivalent in biological, physical, health, pharmacy or related science; 5+ years of relevant GCP experience or 3+ years with an MS / equivalent, preferably within a CRO or pharmaceutical setting.

Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA CFRs, European Directives and UK Statutory Instruments relevant to GCP.

Excellent understanding of drug development processes.

Experience in supporting Regulatory Inspections is preferred.

GxP knowledge (e.g., GLP, GMP) in addition to advanced GCP knowledge preferred.

Domestic and international travel may be required (not exceeding 15%).

Worldwide is an equal opportunity employer committed to enabling professionals from all backgrounds and experiences to succeed. We value diversity and an inclusive environment that fosters collaboration and creativity.

For more information on Worldwide, visit or connect with us on LinkedIn. Get notified about new Senior Quality Assurance Lead roles in Barcelona, Catalonia, Spain.

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Qa Lead • Barcelona, Cataluña, España