EY Risk Adv - Business Con Quality Reg 

United States, New Jersey 

863835609

Full time employment, Monday – Friday, 40 hours per week, 8:30 am – 5:30 pm.

MINIMUM REQUIREMENTS:

Must have a Bachelor’s degree in Pharmacy, Biology, Chemistry, Biomedical Engineering, Quality Engineering, Manufacturing, Information Technology or a related field and 5 years of progressive, post-baccalaureate related regulatory life sciences compliance experience. Alternatively, will accept a Master’s degree in Pharmacy, Biology, Chemistry, Biomedical Engineering, Quality Engineering, Manufacturing, Information Technology or a related field and 4 years of related regulatory life sciences compliance work experience.

Must have 4 years of Life Sciences advisory, consulting, or industry experience including all of the following:
- Experience working with Life Science regulatory statutes;- Experience with implementation of digital validation lifecycle management systems; and

Must have 4 years of experience in designing and executing Quality Management Systems for Life Science organizations including all of the following:
- Complaints management processes
- CAPAs
- Deviations
- Change control quality audit management.

Must have 3 years of experience in one of the following quality and risk management systems: QMS; DMS; Safety; LIMS; or RIM using Veeva, Trackwise, EtQ Reliance, Argus, or Calyx in any of the following roles: Business process analyst; Technical writer; Project manager; or Computer systems validation.

Must have 2 years of experience leading workshops and client-facing presentations.

Must have 1 year of experience in project management for large scale process, risk, controls, audit, or technology projects and programs, preparing and delivering reports, and managing program budget and timelines effectively.

Must be eligible to obtain AIGP, CA/ACA, CIA, CISA, CMA, CMDA, CPA, CQA, CRISC, FSA, GARP – FRM, GARP – SCR, IRM – ERM, IRM – ORM, ISF – Level 3, RAC, RIMS-CRMP, and/or relevant certification within one year of hire.

Employer will accept any suitable combination of education, training or experience.

What we offer

We offer a comprehensive compensation and benefits package where you’ll be rewarded based on yourperformance and recognized for the value you bring to the business. The base salary for this job is $188,178.00 per year. 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.

• Continuous learning: You’ll develop the mindset and skills to navigate whatever comes next.

• Success as defined by you: We’ll provide the tools and flexibility, so you can make a meaningful impact, your way.

• Transformative leadership: We’ll give you the insights, coaching and confidence to be the leader the world needs.

• Diverse and inclusive culture: You’ll be embraced for who you are and empowered to use your voice to help others find theirs.

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.

For those living in California, please

This particular position at Ernst & Young in the United States requires the qualified candidate to be a "United States worker" as defined by the U.S. Department of Labor regulations at 20 CFR 656.3. You can review this definition at at the bottom of page 750. Please feel free to apply to other positions that do not require you to be a "U.S. worker".