Description
Be part of something altogether life-changing!
Working at Cytiva 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.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The Quality Compliance Officer for Cytiva is responsible for:
+ Maintain site compliance and certification status.
+ Maintain a healthy quality management system at site and stay aligned with other global sites.
+ Ensure site team’s compliance with both internal & external quality training requirements.
+ Stay connected with global QARA community to implement changes and drive improvement.
+ This position is part of the China QARA located in Shunyi District of Beijing and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
In this role, you will have the opportunity to:
+ Host external audits including customer audits and audits by regulatory bodies, responsibilities include audit scheduling, site introduction, organizing local SMEs to respond to audit questions, receipt of audit reports, providing site response, follow up on findings and observations till closure.
+ Organize site internal audits and host corporate level audits. Track all audit findings till closure.
+ Create and manage audit records in company system for both external and internal audits.
+ Take responsibility for QMS implementation at site, use audits and gemba walks to drive improvement.
+ Own quality documentation and document control covering document creation, modification and revision, till document obsolescence.
+ Be the site administrator for quality training, provide training and communication to the site team to ensure that quality training requirements are met, and site quality training plan & records are maintained.
+ Report out on audit, QMS and training related KPIs.
+ Support quality related projects and activities.
The essential requirements of the job include:
+ 3+ quality management system experience with a Bachelor degree in a scientific field, preferable in Lifesciences (biomedical, chemistry, pharma,…)
+ Skills:
+ Language: English (written & spoken)
+ Strong working knowledge of quality management system
+ Familiarity with ISO9001
+ Experience in a regulated industry preferred
+ Good working knowledge of MS Office software
It would be a plus if you also possess previous experience in:
+ Knowledge of ISO 13485 a plus
+ Track record of successful external audit hosting.
+ Strong interpersonal and communications skills
+ Excellent planning, organization, and presentation skills
+ Fast learner with good cross functional leadership capabilities
+ Ability to multi-task, solve problems and make decisions
+ Works collaboratively with other functions
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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.
