Quality Director Gxp

4 giorni fa

Roma, Italia Qualitas A tempo pieno

Qualitas is partnered exclusively with a leading international CRO who specialise in Pharmacovigilance, Quality Assurance, Clinical, and Consulting services to global Pharmaceutical, and Biotech companies.

They are seeking a Quality Assurance Director to lead and expand Quality Assurance services while leading and 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.

**Duties**:

- Ensures day-to-day activities of the QA Services team
- Develops the workflow and operational planning for QA Services, overseeing the delivery of all projects within the department
- Manages the QA service project portfolio and its risk
- Ensures department profitability through efficient resource allocation and billability
- Works closely with the Business Development team to grow QA Services, helping to develop plans for expanding the client base and services offered.
- Ensures clients receive the requested services, guaranteeing the quality of the project delivery within the agreed budget and timelines
- Participates in Client meetings as required and overseeing all customer proposals
- Ensures that Quality & Projects Plans are developed according to client requirements
- Ensures tracking of all relevant compliance metrics
- Identifies successful drivers for defining and managing KPIs for strategic processes to guarantee continuous improvement of QA services
- Where necessary, prepares and performs audits on behalf of clients, and relevant reporting to them
- Manages external Auditors and engages them as appropriate
- Escalates to the MD of Services and relevant CALS any Critical Risks for Client relationships
- Contributes to and ensures optimal public relations activities and brand awareness
- Assesses customers’ feedback and makes necessary improvements
- Ensures that Department processes are efficient and cost-effective
- Guarantees 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 of 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 Types**: 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)

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