- Provide leadership to a team responsible for all elements of the QMS in line with the Cytiva global QMS, customer expectations and applicable regulations.
- Define, develop and implement QMS requirements applicable to support a customer orientated services and solutions organisation with close links to the Cytiva global QMS 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.
- Understand customer requirements and expectations as well as business needs and take proactive measures to leverage the BIS QMS as a competitive advantage for the business and champion continuous improvement.
- Develop QMS improvement plans and lead efforts to reduce/mitigate any risk to the compliance. Drive opportunities to leverage best practices Lead process standardization and improvement. Host ISO 9001 audits, certification and surveillance, support other external audits, where needed.
- 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 managing teams and working cross – functionally and at global level
- Experienced in continuous improvement methodologies & tools (LEAN six sigma) is desired.
- Experienced in hosting and managing customer and regulatory audits/inspections.
- QMS leadership experience in a software environment is desirable.
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Senior Quality System Manager - Amersham, Bucks., United Kingdom - Danaher
Description
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.
Cytiva is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
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 QMS manager will also be responsible for the maintenance of ISO 9001 certifications as well as the adherence to other applicable regulations including GMP. 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.
What you'll do:
Who you are:
It would be a plus if you also possess previous experience in:
At Cytiva we believe in designing a better, more sustainable workforce. 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. Explore the flexibility and challenge that working for Cytiva can provide.
The salary range OR the hourly range for this role is $110000 – $ 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. We may ultimately pay more or less than the posted range. This range may be modified in the future.
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-Remote
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
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.
