QA Director Resins TechnologySite QA Leader
QA Director Resins TechnologySite QA Leader
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Job Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology
At Cytiva one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake lifesaving 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. Take your next step to an altogether lifechanging career.
Learn about the Danaher Business System which makes everything possible.
We are looking for an experienced Quality Assurance (QA) Professional to lead our Cytiva Uppsala site Quality Assurance organization and Quality Management System (QMS). You will collaborate closely with cross functional leadership and associates to ensure compliant monitoring and continuous improvement of the QMS in line with certification requirements and supporting customer expectations.
This role will report directly into the Global QARA organization and is based onsite at our Uppsala site. Do you have a passion for Quality Assurance Then we would love to hear from you.
What youll do
- Represent the Uppsala site as the lead Quality Management Representative Responsible for the leadership & development of the Uppsala QA function.
- Support the Global QMS team on Global process and procedure changes and represent the needs of the site during change management and continuous improvement discussions.
- Accountable for setting & monitoring Quality KPIs including reporting on performance/ trend insights within business reviews.
- Ensure adequate QA support to Site Projects including new product development
- Ensure QMS procedures work instructions and IT System effectively support the Uppsala organization Collaborate with Global QMS systems documentation control and training leaders as required.
- Coach/mentor Uppsala associates on QMS requirements
- Ensure effective communication style with stakeholders and establish cross functional operating mechanisms where appropriate to ensure Quality goals are met.
Who you are
- Bachelors degree in a Science or Engineering discipline
- Extensive experience working in Quality Assurance/Quality Engineering within Life Science Medical Device or Biopharma manufacturing environments
- Senior leadership experience within Quality Assurance/Quality Engineering
- Comprehensive understanding of ISO 9001 & ISO 13485 requirements.
- Excellent communication skills (written and oral) fluent in both Swedish & English
- Experienced in managing project teams and working cross functionally both locally & globally.
- Exceptional analytical problem solving & rootcause analysis skills.
- Demonstrated expertise to effectively communicate within all levels of the organization around the entire product life cycle management (design controls verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA) complaints & risk management services)
- Experienced in continuous improvement methodologies & tools (i.e. LEAN six sigma DBS SPC and data trending)
To be successful in this role we believe that you possess excellent organizational presentation and technical writing skills. You can handle tasks with competing priorities effectively as well as exercising collaboration negotiation & conflict resolution. You enjoy working in a dynamic cross functional environment and having responsibilities expanding globally as well as locally.
It would be a plus if you also possess previous experience in:
- Understanding of GMP requirements.
Does this sound interesting Welcome in with your application today!
Applications will be read and reviewed continuously.
#LIOnsite
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Join our winning team today. Together well accelerate the reallife impact of tomorrows 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.
For more information visit www.danaher.
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.
Required Experience:
Director
Employment Type
Full-Time
