Manager - Quality Management Systems at Kalypso in Remote

Kalypso, a Rockwell Automation Company, is a professional services firm dedicated to helping clients discover, create, make and sell better products with digital. We believe that innovation across the value chain is the single most important factor for long-term growth and success. Kalypsonians are passionate about their work and committed to helping our clients become more innovative, competitive, and productive. The Kalypso team consists of diverse industry and technical experts with proven experience delivering results. Our people are recognized business, industry, and technical thought leaders with a passion for innovation. As a provider of professional services, our people are the key to success. We are looking for the absolute best to join our world-class team. We want balanced individuals who are willing to go the extra mile to deliver the results our clients expect. At the same time, we are looking characters with character who complement their expertise and intelligence with... personality and integrity. If you think you have what it takes, but don't meet every single point on the job description below, please still apply. We'd rather have a chat and see if you could be a great fit than never meet at all. Kalypso is seeking exceptional candidates who are looking for an exciting career as a Manager - Quality Management Systems (QMS). As a Manager - QMS , you will help clients solve challenging QMS issues in Complaints, Non-Conformance, Corrective Action (CAPA), Regulatory Submission and meeting Compliance and changing regulatory challenges. The work is fast paced, demanding, and provides unparalleled exposure to unique opportunities to work closely with industry leading companies to transform their business. Our focus is helping clients extract value from programs, transform the way they do business, and accelerate leading practice delivery on leading software solutions - we are not just making technology work. In this role, you will help re-design business processes, based on industry leading practices, work with client and Kalypso technical teams to install, design, develop, test, and drive adoption of innovative software solutions for a diverse set of both large and small Life Sciences clients looking to Kalypso for innovative solutions. Responsibilities: Achieve a balance between meeting client obligations, supporting their needs, and acting as an ambassador for the firm Lead business process workshops Conduct application design to support business processes in a variety of technical environments Design and configure QMS software solutions to incorporate new business processes Train client personnel in QMS concepts and QMS software tool capabilities and functionality Define Data Cleansing programs for client to execute Perform migration design and loading activities Assist in designing and developing custom reports and queries Write and propose Functional specifications to support design Lead business process and QMS Solutions discussions to present and define/configure processes & workflow solutions for clients Consulting: Integrates analytical results and recommendations into solution for client Seeks to understand cultural norms/communication styles of team members and leverages diverse styles on the project Provides mentorship and guidance to the team Leads the team and ensures excellence in delivery Superior analytical, technical, and problem-solving skills Effective organization and time management skills, with ability to work under pressure and adhere to project deadlines Excellent written, verbal, presentation, and interpersonal communication skills Versatility, flexibility, and proactivity when resolving technical issues and dealing with ambiguity Demonstrated ability to communicate effectively and collaborate with clients, peers, and managers Requirements: At least 4-6 years of work experience in the Life Sciences/Medical Device Industry working with Quality, Document Control or Regulatory organizations 2-4 years of previous experience with a leading QMS system or as a practitioner of Quality Management including complaint handling, non-conformance, corrective action, quality assurance, design control, audit support, etc. Consulting experience is a plus Experience with emerging cloud, hosting and web technologies is a plus Knowledge of Quality Management or Document Management software solution capabilities, such as Trackwise, Master Control, Pilgrim, ETQ, Documentum, etc. Experience with PTC Windchill, Oracle Agile 9 or Oracle Cloud PLM/QMS for Product Development, Customer Experience, Non-conformance, CAPA is a plus Proficiency in Microsoft suite tools such as PowerPoint, Excel, Visio, etc. Experience with Sales Force, SAP SuccessFactors, ERP, Supply Chain and CRM solutions Ability to establish effective working relationships in a team environment Effective organization and time management skills, with ability to work under pressure and adhere to project deadlines Strong communication skills in English, both written and verbal Must be willing to travel up to 80% in United States, some additional international travel too Job is based in the US and no specific location is required All applicants applying for US based job openings must be authorized to work in the US Salary Range: $80K -- $100K Minimum Qualification Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualificationsShow full descriptionCollapse