Danaher Corporation QA Leader in Seoul, South Korea
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
This position is responsible for QA support in Asia region by driving compliance activities around Enterprise Solutions businesses. This role is also responsible for completing and maintaining oversight quality related activities including but not limited to document control, compliance training, customer interactions, complaints and CAPA management.
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.
Quality Specific Goals
Aware of and comply with the Cytiva Quality Manual, Quality Management System, Quality Management policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Complete all planned Quality and Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Assure site and business is properly prepared for external and internal compliance inspections.
Assure organizational goals are established and met for compliance, on-time delivery, and audit response, operating mechanisms, complaint response and CAPA
Who you are
Bachelor's degree, plus 8 years working experience and understanding of product development, manufacturing, quality control and project management in a pharmaceutical or medical device environment).
Minimum 5 years Quality Assurance/Regulatory Assurance experience in the pharmaceutical or medical devices industry.
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.
Proven managerial/leadership skills such as work planning, delegating and evaluating
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and in-depth understanding of site level products and related processes
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective and Preventive Action (CAPA), complaints and risk management etc.
Demonstrated collaboration, negotiation and conflict resolution skills
Excellent oral communication , report, business correspondence and procedure-writing skills
Proven mentoring and coaching abilities, demonstrated ability to motivate and inspire others
Proven leadership skills (experience successfully managing people/projects/issues)
Demonstrated ability to lead, acknowledge, develop, communicate and implement a strategy under crisis situations to ensure compliance
Change agent with energy, passion and enthusiasm to drive change
Demonstrated effective interpersonal, teamwork and networking skills
Exceptional analytical, problem solving and root-cause analysis skills
Ability to make decisions, even when under pressure and take ownership for assigned projects and programs
Ability to multi-task and handle tasks with competing priorities effectively
Integrity, Accepting and adhering to high ethical, moral and personal values in decisions, communications, actions and when dealing with others
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) .
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 Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) 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.