Digital Quality Transformation - Senior Consultant - Life Sciences (QMS)

Location: New York, Atlanta, Boston, Chicago, Dallas, Hoboken, Houston, McLean, North Carolina, Philadelphia. 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: Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.) Regulatory Affairs (regulatory submissions, health registration management, etc.) Laboratory Information Management Systems Computer Systems Validation (following a GxP system development lifecycle) 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 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. Implementation of validation lifecycle management systems (e.g., ValGenesis, Kneat). Design and execution of QMS and regulatory processes. Perform computer systems validation activities as part of service delivery. Perform quality audits of client processes within the QMS area. Full‑time employment; travel required up to 40%. Skills and Attributes for Success Performing large‑scale implementations with consistent high‑quality delivery. Driving high‑quality work products within expected timeframes and on budget. Ability to monitor progress, manage risk, and ensure key stakeholders are kept informed. Staying abreast of current industry trends relevant to the client’s business. Effectively working on teams with diverse skills and backgrounds. Fostering an innovative and inclusive team‑oriented work environment. Demonstrating deep technical capabilities and professional knowledge. Qualifications A bachelor’s or master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least three years of related work experience. At least three 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. Ideally, you’ll also have Experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems. 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 You We offer a comprehensive compensation and benefits package based on performance, with a base salary range for all U.S. locations of $93,600 to $154,500. The range for the New York City Metro Area, Washington State, and California (excluding Sacramento) is $112,400 to $175,600. Individual salaries are determined by education, experience, skills, and geography. We include medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. Our hybrid model expects most client‑serving professionals to work in person 40‑60% of the time throughout an engagement or project. Under our flexible vacation policy, you decide how much vacation time you need, and you will also receive time off for EY paid holidays, winter/summer breaks, personal/family care, and other leaves of absence as needed. EY accepts applications for this position on an ongoing basis. Equal Employment Opportunity EY provides 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. If you have a disability and need assistance applying online or require an accommodation during any part of the application process, please call 1‑800‑EY‑HELP3, select Option 2 for candidate‑related inquiries, then Option 1, and then Option 2 for candidates with an inquiry. Alternatively, email the Talent Shared Services Team at View email address on click.appcast.io. #J-18808-Ljbffr EY