Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.). In addition, our team also works on projects with clients to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure.. Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in the roles of business process analyst, technical writer, project manager, computer systems validation, and other business / project roles associated with delivery and execution.. A bachelor's or master's degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least 3 years of related work experience.. Experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems

implementation consultant

EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities. At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. This position can be anywhere in the country Our clients operate in a world where achieving high performance is just as important as the patients they serve. EY's Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting their organization's performance and impacting patient safety. The opportunity The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry. You will be an integral part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team advises clients on aligning risk and business objectives from strategy to execution and improving coordination of risk activities across the organization for better outcomes. This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally: <ul><li>Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.)</li><li>Regulatory Affairs (regulatory submissions, Health Registration Management, etc.)</li><li>Laboratory Information Management Systems</li><li>Computer Systems Validation (following a GxP system development lifecycle) </li></ul>In addition, our team also works on projects with clients to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure. Your key responsibilities Your time will be spent supporting client engagement teams to deliver projects in the life sciences domain, including: <ul><li>Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in the roles of business process analyst, technical writer, project manager, computer systems validation, and other business / project roles associated with delivery and execution.</li><li>Implementation of validation lifecycle management systems (e.g. ValGenesis, Kneat).</li><li>Design and execution of QMS and Regulatory processes.</li><li>Performing computer systems validation activities as part of a service.</li><li>Performing Quality audits of client processes within the QMS area. </li></ul>You will also be expected to work on teams to consistently deliver quality client services by demonstrating in-depth technical capabilities and professional knowledge and maintaining long-term client relationships. Full time employment, Travel required up to 40%. Skills and attributes for success <ul><li>Performing large-scale implementations with consistent high quality delivery</li><li>Driving high-quality work products within expected timeframes and on budget</li><li>Ability to monitor progress, manage risk, and ensure key stakeholders are kept informed about progress and expected outcomes</li><li>Staying abreast of current industry trends relevant to the client's business</li><li>Effectively working on teams with diverse skills and backgrounds</li><li>Fostering an innovative and inclusive team-oriented work environment</li><li>Demonstrating deep technical capabilities and professional knowledge </li></ul>To qualify for the role you must have <ul><li>A bachelor's or master's degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least 3 years of related work experience.</li><li>3+ years of Life Sciences work experience, including working with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs or integration of risk management functions. </li></ul>Ideally, you'll also have <ul><li>Experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems </li></ul>What we look for We are interested in passionate leaders with strong delivery capability, and a strong desire to stay on top of trends in the life sciences industry. If you have a strong passion for helping businesses drive measurable value while serving patients, then this role is for you. What We Offer We offer a comprehensive compensation and benefits package where you’ll be rewarded based on your performance and recognized for the value you bring to the business. The salary range for this job in most geographic locations in the US is $82,800 to $136,600. The salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $99,400 to $155,300. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances. You’ll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being. <ul><li>Continuous learning: You’ll develop the mindset and skills to navigate whatever comes next.</li><li>Success as defined by you: We’ll provide the tools and flexibility, so you can make a meaningful impact, your way.</li><li>Transformative leadership: We’ll give you the insights, coaching and confidence to be the leader the world needs.</li><li>Diverse and inclusive culture: You’ll be embraced for who you are and empowered to use your voice to help others find theirs. </li></ul>If you can demonstrate that you meet the criteria above, please contact us as soon as possible. The Exceptional EY Experience. It’s Yours To Build. EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. EY is an equal opportunity, affirmative action employer providing equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law. EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, type Option 2 (HR-related inquiries) and then type Option 1 (HR Shared Services Center), which will route you to EY’s Talent Shared Services Team or email SSC Customer Support at ssc.customersupport@ey.com

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