Senior QA Specialist

**About**CPI**:
CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.

Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.

From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.

**Why this role is important for CPI’s work**:
**Join Our Team and Make a Difference**

We are currently looking to hire a Senior Quality Assurance Specialist, who will play a pivotal role in leading quality assurance activities and integrating quality into every aspect of our business. The role will provide expertise and input on the quality management system (QMS) compliance for the CPI Biologics RNA Centre of Excellence at Darlington.

This is a fantastic opportunity for an experienced Quality professional to contribute to ground-breaking projects and work with a diverse team of experts dedicated to excellence.

**Key Tasks in the Senior**QA** Specialist Role**:

- Implement, monitor, and maintain the CPI Biologics GMP QMS to support GMP manufacturing activities.
- Lead and perform first line management for the other Quality Specialists and Quality Officers providing strong leadership, direction and continuous development opportunities (up to 5 direct reports)
- Guide and advise on all aspects of manufacturing, QC, and supporting operations within the RNA Centre of Excellence as the GMP SME.
- Lead regulatory inspections and support customer audits of the facility.
- Lead in the resolution of manufacturing, testing and packaging issues to support the release of products.
- Perform root cause investigations and quality risk assessments to GMP standards.
- Author, review, and approve policies, SOPs, work instructions, and other quality documentation.
- Oversee the supplier assessment program, including audits, supplier evaluation, and technical quality agreements.
- To actively contribute to a culture of continuous capability development through coaching, mentoring and/or developing colleagues within the team and business unit, providing insights into areas of specialism.

For full details, please download the job description available on the CPI careers page.

**The person we are seeking**:
**Essential**:

- Significant QA experience/expertise and understanding of GMP requirements.
- Educated to atleast a HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline plus significant industrial experience at a senior level.
- Ability to work in a fast-paced environment with flexibility to adjust to moving priorities.
- Strong attention to detail with a thorough approach and good organisational skills.

**Desirable**:

- Chartered status with a relevant professional institution.
- Knowledge of ISO 9001 Quality Management System Standards and EU GMP Guidelines.
- Experience in the use of Electronic Document Management systems and QMS.
- Previous line management experience

**What does**CPI** offer you?**:
At CPI, we offer a wide range of benefits to our employees, this includes:

- Up to 36 days holiday, including bank holidays - Plus a holiday purchasing scheme
- Generous pension scheme
- Life assurance and accident insurance schemes
- Flexible working
- Learning and Development Opportunities
- Free parking

Find out more about our culture and benefits.

**Additional information**:
CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.