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 remote Quality Assurance Director to lead and expand Quality Assurance services while leading and developing a team of QA professionals nationally and internationally.

Responsibilities

• Oversee the design, delivery, and continuous improvement of QA services across client engagements, ensuring regulatory compliance, operational excellence, and customer satisfaction.
• 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 QAS 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 QAS 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