Lead Engineer-Business Support, Regulatory & Supplier Quality
Cytiva
Tauranga, New Zealand
5d ago

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 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.

What you’ll do

  • Responsible for all functions and associated tasks required to support the implementation and development for qualifying and supervising suppliers at Cytiva, Manufacturing Operations.
  • Regulatory affairs regarding importation, storage, and exporting of Serum / products in ANZ
  • Business continuity accreditation ISO22301 certification and ongoing compliance of the systems.
  • Write and maintain procedures in line with Cytiva policies, SOP’s, WID’s.
  • Assure supplier compliance to Cytiva QMS and regulatory requirements through the supplier monitoring process.
  • Who you are

  • Minimum of five (5) years of progressive Quality Assurance experience
  • In-depth knowledge and experience in the serum for the cell culture industry.
  • Regulatory experience including ISO9001 : 2015 and ISO13485 : 2016, ISO17025 : 2017, and ISO22301 : 2012.
  • Systems orientated and an eye for detail.
  • Familiarity with Quality / CGMP required.
  • Effective oral and written communication skills
  • LI-DJ2

    When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 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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