Job details
Job type full-time
Full job 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 healthOur 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 patientsWith 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 termCytiva is proud to work alongside a community of nine fellow danaher life sciences companiesTogether, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
What you’ll do
This position will lead a team of qa leaders who have responsibility for the qa activities within cytiva enterprise solution projects on site at customer premises in uscan regionThis position will also be required to support qa activities at customer facilities, and as the leader of the team, will be responsible for ensuring team training & their compliance to the cytiva enterprise solution qms which includes team responsibility for; document control, change control, deviation, complaint & capa management and responding to customer feedback.
Accountable for ensuring fulfillment of customer requests from the quality assurance organization.
Ensures readiness of facilities, systems, and operating mechanisms in compliance with cytiva requirements.
Coordinate qualification documentation, validation protocols and reports from draft to approval.
Domestic and/or international travel to support flexfactory (ff) and kubio project on-site qualification document control, include but not limit to, documents from sat, automation, iq, oq etc.
Participates in establishment of equipment testing document for ff products.
Conducts trainings, such as gdp, gmp (21 cfr part 210/211, part 820) and document control, to the project team as necessary.
Administers deviations in accordance with internal procedure.
Responsible for escalation and categorization of risks associated with teams’ interactions with customers, third parties, regulators, and operating mechanisms.
Support coordination and oversight of kubio qualification.
Supports ad-hoc assignment based on business needs.
Who you are
Bachelor`s degree, plus 10 years working experience and understanding of product development, manufacturing, quality control and project management in a pharmaceutical or medical device environment).
Minimum 8 years quality assurance/regulatory assurance experience in the pharmaceutical or medical devices industry.
Minimum 5 years supervisory/ team management experience
Demonstrated validation experience in pharmaceutical or medical device industry.
Familiarity with hvac system, wfi, pw and automation for environmental monitoring requirements.
Proven experience in ispe, gamp5 and gmp requirements.
Hands-on experience with fda, qsr, iso(iso9001/iso13485), mdd and /or other international quality systems requirements.
Prior experience using word processing, spreadsheet, and presentation software.
Frequent travel and working at customer site are required based on needs from different project phases.
Ability to multi-task and handle tasks with competing priorities effectively.
Ability to communicate using english while embracing team diversity from worldwide.
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 winAs 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 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 heardWe 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!
Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or e-mail applyassistance@danaher.com to request accommodationDanaher 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 lawThe “eeo is the law” poster is available here .
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 winAs 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 tools and the stability of a tested organization.
