Quality Director GxP

Overview

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.

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

The company are happy for Managers/Snr Manager to apply who are looking for a step up or someone who is already at this level.

Please apply if you are interested in this exiting opportunity

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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