Global QA Director - Filters And Single Use Systems

Danaher Westborough , MA 01580

Posted 7 days ago

Are you looking to take the next step in your career?

Pall is looking for a Global Quality Assurance Leader to sit within Biotech and lead all aspects related to Quality Assurance & QMS Compliance within our SUS, Filters portfolio.

We are seeking for a strong leader, an individual able take ownership of the quality management system that meets ISO 9001 and Pall International / corporate requirements, while driving the organization to superior performance results This leader firmly guides the team to guarantee that our products are delivered respecting our high quality standards, ultimately targeting to meet and where possible exceed our Customer's expectations. Furthermore, you will act as a partner with suppliers, customers and members of all departments such as Operations, Sales, Purchasing, Strategic Sourcing, Engineering, R&D, etc.


  • Undertake all necessary actions to ascertain that the Biotech Filters sites are aligned with ISO 9001, Pall international & Corporate requirements, all relevant product standards and legislation and / or customer specific requirements;

  • Work in close collaboration with VP QARA Biotech, to roll out and implement CORP Quality Procedures, ensuring the proper communication and training is in place across the sites/areas in scope, when applicable.

  • Drive, plan and supervise customer visits/audits; support the implementation of customer audit program including standard work for customer audits;

  • Participate in R&D meetings as an "executive sponsor" in projects;

  • Lead Biotech Filters customer complaint CAPA and NCR processes; adhere to corporate critical issue and reporting guidelines;

  • Oversee supply management processes, including supplier approval, monitoring and development;

  • Support sites' management reviews meetings in scope, in line with corporate guidance and implement BU Audit program;

  • Implement continuous improvement practices, including appropriate kaizen events on relevant Quality processes;

  • Act as a Project Manager in situations related to Customer Complaints affecting products in scope, liaising with the different areas of the organization to mitigate and solve the issue in a timely manner; acts as the senior point of contact to Customer Complaints of the products in scope.

  • Work in close collaboration with peers QA Leaders to foment a Biotech Quality culture of sharing best practices and permanent alignment.

  • Drive and/or support the implementation of Product Quality Review in the portfolio in scope.

  • Maintain key user support resources for QARA software solutions, including Pilgrim;

  • Manage Biotech Filters QARA organization to meet corporate & BU goals; clearly define roles and responsibilities;

  • Oversee coordination of responses to QA related customer questionnaires, requests and surveys; prepare and maintain/update standard responses/data for use by Customer Service;

  • Participate in Customer meetings and visits, representing the QARA Biotech Senior Leadership whenever needed or appropriate.

  • Support implementation of Regional & Biotech specific Regulatory & Market requirements based on input from the Regulatory Affairs department;

  • Customer Advocate / Voice of the Customer. Ensure alignment with customer requirements, where possible. Build and sustain strong relationships with SAM and KAMs.

  • People's manager - Ensure that all P4G/D4G of your team is updated according to the expectations highlighted and communicated by HR.

Education and Competencies:

  • Bachelor's degree in a biological science, engineering, or related scientific field;

  • Experience working in biotech, chemical, pharmaceutical industry, preferably in management/leadership positions;

  • Master's degree in Quality Engineering/Management is a plus;

  • Six Sigma / Lean Manufacturing sound knowledge; strong statistical skills;

  • Strong leadership, collaboration, and influencing skills; demonstrated ability to problem solve and drive positive change;

  • Ability to deal effectively with a diversity of individuals at all organizational levels;

  • Excellent interpersonal, oral, and written communication skills; ability to successfully interact with key internal partners and vendors;

  • Fluent in English, other languages are an asset.

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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Biomanufacturing Associate 2 WednesdaySaturday 700Am 530Pm


Posted 6 months ago

VIEW JOBS 5/11/2020 12:00:00 AM 2020-08-09T00:00 Help us improve access to life-changing therapies that can transform human health We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020. Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes. What you'll do As Biomanufacturing Associate 2, be responsible for current Good Manufacturing Practices (cGMP) production activities. Perform manufacturing operations according to standard operating procedures and batch instructions. Responsibilities include training on cGMP manufacturing operations: Operation and monitoring of cell culture and/or purification equipment; Media and solution preparation; Writing, reviewing and revising of cGMP documentation. SHIFT HOURS: Wednesday-Saturday 7:00AM to 5:30PM * Demonstrates effective written and verbal communication skills. * Reads and follows Standard Operating Procedures (SOPs) and Master Production Records (MPRs). * Executes and properly documents cGMP Biomanufacturing activities. * Ability to work within ISO 6/7/8 clean room environments. * Performs aseptic techniques within in a clean room environment. * Operates cGMP Biomanufacturing equipment, including; pH/conductivity meters, single use mixing tanks (XDM's), tubing fusers/sealers, filter integrity testers, cell counters, metabolite analyzers, peristaltic pumps, balances and biosafety cabinets (BSC). * Performs buffer and media preparation. * Performs processes of small and large scale cell culture production of mammalian cell lines, including cell counting, cell passaging and culture metabolite analysis. * Operates Cell Culture and/or Protein Purification production equipment in a cleanroom environment, including; * Incubators, Wave Reactors, Single Use Bioreactors (XDR) * Chromatography skids, Depth Filtration, Viral Filtration and Tangential Flow Filtration * Review completed cGMP documentation for accuracy. * Routinely originate or revise standard operating procedures, master production records and solution preparation records. * Works scheduled shift and other off-shift coverage as required. * Works with team leads; engineers, supervisors, and managers to improve quality and process efficiency. * Actively participate in maintaining a safe work environment by completing required training, providing suggestions for improving the health and safety program and bringing unsafe acts and/or conditions to the attention of management. * Complies with all EHS and Quality policies and procedures. * Maintain cleanliness of cleanroom in accordance with cGMPs and facility procedures. * Perform other duties as assigned. Who you are * Associates Degree/ Biotechnology Certificate/Diploma with a minimum of 2 years experience in biologics manufacturing under cGMP. * High School Diploma or equivalent with a minimum of 3 years experience in biologics manufacturing under cGMP. * Demonstrates ability to work in a rapidly changing climate and reacts well to change. * Demonstrates ability to communicate, receive and understand instructions regarding duties to be performed * Demonstrates strong attention to detail and have quality-minded work habits * Demonstrates ability to communicate with co-workers and leadership * Demonstrates ability to follow instruction and standard operating procedures. * Reliable, dependable, and organized. * Able to recognize problems developing, not just occurring. * Ability to work additional hours as needed to support production. Desired Characteristics * Degree in a scientific discipline or equivalent experience. * Cell Culture experience. * Protein Purification experience. * Prior experience working in a cGMP biopharmaceutical manufacturing environment. * Experience with single-use biomanufacturing systems. Who we are Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you'll feel right at home here. If you're flexible, curious and relentless, you'll belong. If you are excited about a global culture, this can be the place to further your career. Want to know more? Take a look at our Instagram, Twitter and LinkedIn pages! Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients. As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher's unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life's Potential. 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. Danaher Westborough MA

Global QA Director - Filters And Single Use Systems