Quality Assurance Director

Qualitas; Newcastle upon Tyne; Remote; GBP 70,000 - 90,000; Full time

Job summary

A leading international CRO is seeking a remote Quality Assurance Director to lead and expand Quality Assurance services. This role involves overseeing the design and continuous improvement of QA services while developing a team of QA professionals. The ideal candidate should have over 8 years of experience in Quality Assurance and strong leadership skills, ensuring compliance and customer satisfaction within the pharmaceutical and biotech sectors.

Qualifications

• 8+ years of relevant work experience in Quality Assurance.
• 3-4 years minimum of leadership/management experience.
• Demonstrable experience of growing Profit and Loss through delivery and client relationships.
• Fluent in English.

Responsibilities

• Oversee design and improvement of QA services.
• Manage the QAS project portfolio and its risk.
• Ensure day-to-day activities of the QA Services team.
• Work with Business Development to expand QA Services.

Skills

Leadership

Regulatory compliance

Client relationship management

Auditing

Continuous improvement

GCP, GLP, or GMP knowledge

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.

Responsibilities

• Oversee design, delivery, and continuous improvement of QA services across client engagements, ensuring regulatory compliance, operational excellence, and customer satisfaction.
• Ensure day-to-day activities of the QA Services team.
• Develop workflow and operational planning for QA Services, overseeing the delivery of all projects within the department.
• Manage the QAS project portfolio and its risk.
• Ensure department profitability through efficient resource allocation and billability.
• Work closely with Business Development to grow QA Services, helping to develop plans for expanding the client base and services offered.
• Ensure clients receive the requested services, guaranteeing quality of project delivery within the agreed budget and timelines.
• Participate in client meetings as required and oversee all customer proposals.
• Ensure that Quality & Projects Plans are developed according to client requirements.
• Ensure tracking of all relevant compliance metrics.
• Identify drivers for defining and managing KPIs for strategic processes to guarantee continuous improvement of QAS services.
• Where necessary, prepare and perform audits on behalf of clients, and provide relevant reporting.
• Manage external Auditors and engage them as appropriate.
• Escalate to the MD of Services and relevant CALS any Critical Risks for client relationships.
• Contribute to and ensure optimal public relations activities and brand awareness.
• Assess customer feedback and make necessary improvements.
• Ensure Department processes are efficient and cost-effective.
• Guarantee 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.

Please apply if you are interested in this exiting opportunity