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Quality Systems Manager
3 months ago
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.
The Senior Manager, Quality Management Systems is a leadership role tasked with building and leading a team responsible for the maintenance, monitoring & continuous improvement of all aspects of the Cytiva Biotechnology Integrated Solutions (BIS) Quality Management system (QMS).
He/she will collaborate closely with Cytiva Global QMS team, fellow Danaher operating companies and quality leadership at each of the business units and sites to ensure the QMS is effectively rolled out and training provided.
The incumbent of this post will ensure the QMS and quality objectives are cascaded in the organization and the right key performance indicators are set up for the team.
Provide QMS support to BIS quality operations leaders including strategic initiatives.Provide all aspects of people management, team's performance, coaching and mentoring of the associates.
Ensure the QMS team's objectives and priorities support the business priorities and projects.
Develop QMS improvement plans and lead efforts to reduce/mitigate any risk to the compliance. Bachelor's degree, preferably in a Science or Engineering discipline with 7 years plus experience as QA supervisor or manager at global level
A minimum of 10 years working in Quality Assurance within Life Science or Biopharma manufacturing environments
~ Hands-on experience with FDA, QSR, ISO(ISO9001/ISO13485), MDD, GMP and /or other international quality systems requirements
~ Exceptional analytical, problem solving & root-cause analysis skills.
~ Experienced in hosting and managing customer and regulatory audits/inspections.
QMS leadership experience in a software environment is desirable.
We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.
This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team.This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.
This job is also eligible for bonus/incentive pay.We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note:
No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.
The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
#LI-RemoteWe partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
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.
