Quality Director Gxp

Qualitas; Milano; In loco; EUR 75.000 - 85.000; Tempo pieno

Descrizione del lavoro

A global CRO specializing in pharmacovigilance is seeking an experienced Quality Assurance Director to lead and expand QA services. In this role, you will oversee the QA Services team, ensuring regulatory compliance and operational excellence while developing a team of QA professionals. The ideal candidate has over 8 years of experience in Quality Assurance and significant leadership experience. This position offers a competitive salary of €75,000 to €85,000 per year.

Competenze

• 8+ years of relevant work experience in Quality Assurance.
• 3-4 years of leadership/management experience.
• Fluent in English, with excellent knowledge of GCP, GLP, or GMP regulations.

Mansioni

• Oversee day-to-day activities of the QA Services team.
• Develop workflow and operational planning for QA Services.
• Manage the QA service project portfolio and its risk.
• Ensure profitability through efficient resource allocation.

Conoscenze

Leadership

Quality Assurance

Regulatory Compliance

Client Relationship Management

Auditing

Formazione

Bachelor’s degree in Life Sciences

Descrizione del lavoro

Overview

Qualitas is partnered with a leading international CRO specializing in Pharmacovigilance, Quality Assurance, Clinical, and Consulting services for global Pharmaceutical and Biotech companies. They are seeking a Quality Assurance Director to lead and expand QA services while developing a team of QA professionals nationally and internationally.

You will be responsible for overseeing the design, delivery, and continuous improvement of QA services across client engagements, ensuring regulatory compliance, operational excellence, and customer satisfaction.

Responsibilities

• Oversee day-to-day activities of the QA Services team
• Develop workflow and operational planning for QA Services, overseeing delivery of all projects within the department
• Manage the QA service project portfolio and its risk
• Ensure department profitability through efficient resource allocation and billability
• Collaborate with Business Development to grow QA Services and plans for expanding the client base and services offered
• Ensure clients receive the requested services, guaranteeing quality of project delivery within agreed budgets and timelines
• Participate in client meetings as required and oversee all customer proposals
• Ensure Quality & Projects Plans are developed according to client requirements
• Track relevant compliance metrics
• Identify drivers for defining and managing KPIs for strategic processes to guarantee continuous improvement of QA services
• Where necessary, prepare and perform audits on behalf of clients, and provide relevant reporting
• Manage external auditors and engage them as appropriate
• Escalate to the MD of Services and relevant CALS any Critical Risks to client relationships
• Contribute to and ensure optimal public relations activities and brand awareness
• Assess customer feedback and implement improvements
• Ensure department processes are efficient and cost-effective
• Guarantee compliance with current regulations

Knowledge and Experience Required

• Bachelor’s degree in Life Sciences / Scientific matters
• At least 8 years of relevant work experience in Quality Assurance
• 3-4 years minimum of leadership/management experience
• Demonstrable experience growing a Profit and Loss through delivery and client relationships
• Fluent in English
• Excellent knowledge in either GCP, GLP or GMP regulations
• Auditing experience
• Essential regulatory guidelines worldwide

Job Type: Full-time, Permanent

Pay: €75,000.00 - €85,000.00 per year

Application Question(s)

• Have you got experience working in a CRO / Services / Consulting background?
• Experience
• Quality: 8 years (required)
• GLP: 5 years (preferred)
• GCP: 5 years (preferred)
• GMP: 5 years (preferred)