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