Quality Assurance Director

Qualitas; Ringway; Remote; GBP 70,000 - 95,000; Full time

Job summary

A leading global CRO is seeking a remote Quality Assurance Director to oversee and enhance their QA services while managing a team of professionals both nationally and internationally. Responsibilities include ensuring regulatory compliance, efficient project delivery, and team leadership. Candidates must have substantial experience in Quality Assurance and strong leadership skills. This is an excellent opportunity for those looking to advance their career in a dynamic environment.

Qualifications

• 8+ years of relevant work experience in Quality Assurance.
• 3-4 years of leadership/management experience.
• Fluency in English is essential.
• Experience with GCP, GLP or GMP regulations.

Responsibilities

• Oversee the day-to-day activities of the QA Services team.
• Develop workflow and operational planning for QA Services.
• Manage the project portfolio and its risks.
• Ensure department profitability through efficient resource allocation.
• Work with Business Development to grow QA Services.
• Participate in client meetings and oversee proposals.

Skills

Leadership

Communication

Quality Assurance Knowledge

Regulatory Compliance

Project Management

Education

Bachelor's degree in Life Sciences/Scientific matters

Job description

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. 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

• 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

Qualifications

• 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 exciting opportunity