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Danaher Corporation Bioprocess Quality Assurance Manager in Marlborough, Massachusetts

QA MANAGER

MALBOROUGH, MA, USA

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. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.

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 by driving compliance activities within Cytiva Bioprocess Automation and Digital businesses, reporting to global QA director. This role is also responsible for leading QA team supporting NPI projects. As directed, this role will also support quality related activities including but not limited to document control, compliance training, customer interactions, complaints , NC/ CAPA management, Audits and QMS continuous improvement activities.

  • 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.

  • Support review and approval of NPI documentation as needed

  • Ensures assignment of QA resources for ongoing and new NPI projects

  • Conducts trainings, such as GDP, GMP (21 CFR part 210/211, part 820) and document control, to the team as necessary.

  • Responsible for escalation of risks associated with teams’ interactions with internal teams, customers, regulators, and operating mechanisms.

  • Collaborate with key manufacturing sites and global teams in driving quality metrics, such as complaint, NC, punch list, deviation and CAPA.

  • Provide QMR support to ensure action item follow up and support preparation of presentation to senior leadership.

  • Act as a key contact point with business teams on NPI related issues.

  • 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).

  • Demonstrated validation experience in pharmaceutical or medical device industry.

  • 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.

  • 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 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 Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

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