Lead QA Specialist

3 weeks ago

Portsmouth, United Kingdom Cytiva Full time

The **Lead QA Specialist** for Cytiva is responsible for providing quality assurance leadership and support to the **Process Design & Validation Services (PDVS)** business unit, ensuring services are delivered in compliance with the corporate QMS. The PDVS Fast TrakTM team provides a range of laboratory services to our BioPharma customers, as well as supporting internal R&D and manufacturing projects.

This position supports the Process Design & Validation Services (PDVS) team and is located at the Harbourgate site in Portsmouth, UK. It will be on-site or hybrid. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

**What you’ll do**:

- Take responsibility for BU QMS documentation and processes to ensure compliance with the Corporate QMS, industry and regulatory requirements.
- Manage the deviation and CAPA process. Ensure deviations are correctly captured, investigated, and trended, and that CAPA activities are completed within agreed timelines. Monitor effectiveness of CAPA.
- Host customer, third party and internal audits.
- Manage customer feedback and complaints processes; provide input and approval for change controls; support supplier selection and qualification processes; support requirements for maintaining ISO9001 certification.
- Lead the team in delivering against Quality KPIs and priorities.
- Lead initiatives to reduce the number of internal and external non-conformities, and drive Quality related continuous improvement activities using Danaher Business System tools.
- Support the Global PDVS Quality Leader on Quality related initiatives.
- Collaborate with cross functional and global teams to provide Quality input and oversight in support of business priorities.

**Who you are**:

- Bachelor's degree in an applicable Science discipline, or equivalent experience in a regulated manufacturing industry (e.g Pharma, Biopharm, Life Science, Biotech).
- A minimum of 5 years working in Quality Assurance within Life Science or Biopharma manufacturing or laboratory environments.
- Hands-on experience with the requirements of applicable international quality systems (eg ISO9001, ISO13485, GMP).
- Excellent analytical, problem solving & root-cause analysis skills.
- Experience in hosting or supporting customer, regulatory or third-party audits.

It would be a plus if you also possess previous experience in:

- Continuous improvement methodologies & tools.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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