Jobs · Massachusetts

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

EY · Boston, MA · 1 mo ago
Hybrid$94k–$155k/yrFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We must not repeat job title. Remove boilerplate, navigation, EEO, etc. Keep substantive info. Let's parse the posting. Location list: New York, Atlanta, Boston, Chicago, Dallas, Hoboken, Houston, McLean, North Carolina, Philadelphia. That's location info. Should we include as a section? Not among allowed headings. Could be part of About the role? Probably not needed. Could be omitted as metadata; we can drop minor metadata. The posting includes: - Intro paragraph about EY, mission. - "The opportunity" paragraph describing team. - "Your Key Responsibilities" bullet list (actually sentences). We'll need to extract responsibilities. - "Skills And Attributes For Success" bullet list. - "To qualify for the role you must have" paragraph with qualifications. - "Ideally, you’ll also have" paragraph. - "What We Look For" paragraph. - "What We Offer You At EY" paragraph about compensation and benefits. - Salary ranges. - Benefits: medical and dental coverage, pension and 401(k) plans, wide range of paid time off options. - Flexible vacation policy, hybrid model, travel required up to 40%. - Also mention "Full time employment, Travel required up to 40%." - Also mention "Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year." - Under our flexible vacation policy... Thus we have content for sections: - About the role: could be the introductory paragraphs describing the role/team. Could combine "The opportunity" and maybe first paragraph. - Responsibilities: the bullet list under "Your Key Responsibilities". - Requirements: maybe the "To qualify for the role you must have" paragraph (education + experience). Also "Ideally, you’ll also have" could be part of Requirements or Qualifications. - Qualifications: maybe separate? The instructions say we can have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which to use. We have content for Responsibilities, Skills, Requirements (education/experience), Qualifications (maybe additional preferred qualifications), Benefits, Pay (salary range), Schedule (travel required up to 40%, hybrid model, flexible vacation). We'll include those sections if they have substantive content. We must not create sections with filler like "commensurate with experience". We have actual salary ranges, so Pay section is valid. Schedule: we have travel required up to 40%, hybrid model expectation, flexible vacation policy. That's substantive. Benefits: medical and dental coverage, pension and 401(k) plans, wide range of paid time off options. That's substantive. Skills: we have "Skills And Attributes For Success" bullet list. Requirements: education and experience. Qualifications: maybe "Ideally, you’ll also have" plus "What We Look For". Could be Qualifications. About the role: we can combine the introductory paragraphs about EY and the opportunity. We must not repeat job title. No Job ID. We must output only HTML fragment, no /, no markdown fences. We'll use

for each section heading. Inside sections, use

for prose,

  • for lists. We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep specifics: e.g., list of systems (Veeva, Trackwise, EtQ Reliance, Argus, Calyx), validation lifecycle management systems (ValGenesis, Kneat), etc. Also mention performing Quality audits, etc. We need to keep location list? Might be considered minor metadata; we can drop it per instruction: "Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

    or drop it." Location could be considered minor metadata; we could drop it or include in About the role as a short p. Probably drop it to keep concise. We must not include boilerplate like EEO, legal, etc. Let's extract substantive content. Intro paragraphs: "At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. 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: 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 SystemsComputer 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." That's a lot; we can keep as prose. Responsibilities: list under "Your Key Responsibilities Your time will be spent supporting client engagement teams to deliver projects in the life sciences domain, including: 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.Performing computer systems validation activities as part of a service.Performing Quality audits of client processes within the QMS area. 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." We need to split into list items. The text is a bit run-on; we can separate by sentences. Responsibilities list: - 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. - Performing computer systems validation activities as part of a service. - Performing Quality audits of client processes within the QMS area. - Work on teams to consistently deliver quality client services by demonstrating in-depth technical capabilities and professional knowledge, and maintaining long-term client relationships. Also maybe "Full time employment, Travel required up to 40%." That's not a responsibility but schedule. Skills: list under "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 about progress and expected outcomes - 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 Requirements: "To qualify for the role you must have 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.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." We need to combine: Bachelor's or master's degree in CS, Biomedical Engineering, Quality Engineering, Manufacturing or related field AND at least three years related work experience. Also 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. We can phrase as list. Qualifications: "Ideally, you’ll also have Experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems" plus "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." We can combine as Qualifications. Benefits: "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. 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.Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year.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." We need to separate Benefits (medical/dental, pension/401k, paid time off) and maybe Schedule (hybrid model, flexible vacation, travel). But we have a Schedule section for travel required up to 40%, hybrid model expectation, flexible vacation. We'll put travel and hybrid model in Schedule. Benefits will be medical/dental, pension/401k, paid time off. Pay: salary ranges: base salary range for this job in all geographic locations in the US is $93,600 to $154,500. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $112,400 to $175,600. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. We'll include that. Schedule: "Full time employment, Travel required up to 40%." plus hybrid model expectation (40-60% in person) and flexible vacation policy. We'll make list. Now we need to output HTML. We'll have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Check if any section might be empty: All have content. We must not include filler like "commensurate with experience". Not present. We must not repeat job title. We must not include navigation/legal/EEO etc. We'll omit those. Now craft HTML. We'll start with

    About the role

    then

    ...

    . We'll combine the intro paragraphs into a coherent paragraph. Let's write About the role paragraph: "At EY, we

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