Emea Quality Assurance Leader

2 months ago

Portsmouth, United Kingdom Pall Full time

**Be part of something altogether life-changing**

Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Do you have experience in QA? Are you a skilled communicator able to influence?

As the** EMEA Quality Assurance Leader **for Process Design & Validation Services (PDVS), you are accountable for providing quality assurance and laboratory management leadership and support to the local laboratory operations and project management teams.

**What you’ll do**
- Ensure local QMS related processes and documentation meet requirements of ISO9001, as well as ensuring corporate, customer, industry and regulatory requirements are met. Maintain alignment with the global PDVS team.
- Create an organizational culture of customer and quality focus, integrity, ownership, and accountability by benchmarking and incorporating best practices.
- Accountable for delivering against agreed EMEA quality related KPIs. Generate and issue regular reports to the team to monitor performance.
- Support customers with their supplier quality management needs including planning and hosting customer audits, issuing CAPA responses and driving on time completion of actions. Review and implement customer Quality Assurance Agreements, and complete supplier quality questionnaires as required.
- Ensure that non-conformances and laboratory investigations are correctly captured, investigated, and trended. Monitor effectiveness of CAPA and ensure activities are completed within agreed timelines. Support problem-solving activities to drive a reduction in non-conformances.
- Responsible for the timely completion of Change Control in line with corporate requirements and KPIs.
- Responsible for ensuring regional supplier quality management requirements are maintained (including support with audit, performance monitoring, incoming materials inspection as applicable etc).
- Collaborate with other functional groups, including QARA, Manufacturing, R&D, Marketing, and Engineering.
- Report to senior management on quality issues and trends through periodic quality reviews.
- Educate and train employees as to their impact in the Quality Management System, GMP awareness, and GDP practices. Support the team in working to the principles of GMP where applicable.

**Who you are**
- Bachelors degree in science or engineering discipline.
- Experience of quality assurance in a regulated and scientific industry.
- Minimum three (3) years of lab experience related to validation services (or equivalent).
- Good knowledge of ISO9001 and GDP. Familiarity with GMP, GLP and other industry guidance an advantage
- DBS knowledge and expertise, or equivalent continuous improvement experience, including proven problem-solving skills.
- Strong communication and computer literacy skills.
- Inclination and ability to listen to cross-functional stakeholders and insights.
- Successfully deliver results while quickly adapting to changing priorities and unforeseen challenges.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful **Danaher Business System** tools and the stability of a tested organization.

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.

If you’ve ever wondered what’s within you, there’s no better time to find out.

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