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Danaher Corporation Global Internal Audit Program Manager in Bromma, Sweden

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.

We are looking for an Global Internal Audit Program Manager to work with our specialists Quality and Regulatory Affairs team of over 200 employees across the world. Do you have a passion for Quality Assurance? Then we would love to hear from you.

What you’ll do

  • Development of new global audit program and lead a workstream to identify risks effectively and efficiently.

  • Monitor external inspections/audits (regulatory or notified bodies) across all Cytiva manufacturing sites and report to senior leadership on the outcomes, or any system wide risks and/or developing trends on a quarterly basis.

  • Coordinate identification of top system wide risk projects and/or critical inspections, either leading independently or working with other subject matter experts. Raise needs for resources to assist with gap analysis and identify compliance risks, develop action plans, report progress and ensure closure.

  • Support individual site audit preparation activities, during external regulatory inspections/audits. Identify any resource support needed (external to the site, e.g. CSV)

  • Provide concise and clear findings summaries for leadership.

  • Own and manage the Cytiva Inspection Audit program, of corporate audits of individual sites and functions, in addition to site own inspection program

  • Monitor internal inspections schedules across manufacturing sites

  • Drive the standardization of the Internal Inspection Process across all sites.

  • Work with leadership of functions and sites to drive permanent corrective action in areas of risk as identified in external inspections/audits.

  • Drive business and/or site and modality specific improvement plans according to findings

  • Report on inspection project progress/resolution quarterly and proactively assess risks and execution of plan for audit results.

  • Identify trends and share across the organization site quality units from internal audits results.

  • Carry out audits of sites or function based on the audit program

Who you are

  • Bachelor's Degree and minimum of 7 years working in a regulated medical device industry.

  • Quality Assurance/Quality Engineering experience in the medical device industry or Pharma GMP experience in quality assurance.

  • Understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485 and ISO 9001 and experience working in a regulated environment.

  • Preferred- Certified 9001/13485 auditor.

  • Exceptional analytical, problem solving & root-cause analysis skills.

  • Excellent organizational, presentation, meeting facilitation and technical writing skills.

  • Excellent written and verbal communication skills

  • Experienced in managing project teams and working cross – functionally and at global level

  • Demonstrated collaboration & conflict resolution skills

  • Demonstrated expertise to effectively communicate within all levels of the organization

  • Ability to handle tasks independently and make independent quality decisions

  • Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies

  • Ability to travel globally to perform/support audits as needed (up to 25% travel)

  • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

When you join us, you’ll also be joining Danaher’s global organization, where 68,000 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 Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

We offer comprehensive benefits like Medical, Dental, Vision and matching 401k.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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