Digital Quality Transformation Staff Consultant Life Sciences (QMS)

Philadelphia, PA - USA

Monthly Salary: $ 88700 - 138500

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Location: Arlington Atlanta Baltimore Boston Charleston Chicago Cleveland Dallas Detroit Pittsburg Greenville Hartford Hoboken Houston McLean Metropark Miami New York Charlotte Philadelphia Providence Raleigh Richmond Rochester Stamford St Louis

At EY were all in to shape your future with confidence.

Well 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. EYs Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting their organizations 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 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

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.

Full time employment Travel required up to 60%.

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 clients 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

To qualify for the role you must have

A bachelors or masters degree in Computer Science Biomedical Engineering Quality Engineering Manufacturing or a related field and at least three years of related work experience.
1 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 youll 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
At EY well develop you with future-focused skills and equip you with world-class experiences. Well empower you in a flexible environment and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learnmore.

We offer a comprehensive compensation and benefits package where youll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $73900 to $121800. The base salary range for New York City Metro Area Washington State and California (excluding Sacramento) is $88700 to $138500. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education experience knowledge skills and 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 youll decide how much vacation time you need based on your own personal circumstances. Youll 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.

Are you ready to shape your future with confidence Apply today.
EY accepts applications for this position on an on-going basis.

For those living in California please click here for additional information.

EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities.

EY Building a better working world

EY is building a better working world by creating new value for clients people society and the planet while building trust in capital markets.

Enabled by data AI and advanced technology EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.

EY teams work across a full spectrum of services in assurance consulting tax strategy and transactions. Fueled by sector insights a globally connected multi-disciplinary network and diverse ecosystem partners EY teams can provide services in more than 150 countries and territories.

EY provides equal employment opportunities to applicants and employees without regard to race color religion age sex sexual orientation gender identity/expression pregnancy genetic informationnational 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 select Option 2 for candidate related inquiries then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EYs Talent Shared Services Team (TSS) or email the TSS at .

Required Experience:

Staff IC