Risk Advisor - Bus Cons-Risk Quality-Reg Comp-Life Sc-Manager-Multiple Positions - 1731750

EY•Woodbridge Township, NJ

17h•Hybrid

About The Position

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. Risk Advisor - Business Consulting – Risk Quality - Regulatory Compliance - Life Science - Manager - Multiple Positions - 1731750, Ernst & Young U.S. LLP, Iselin, NJ. Assist clients in the Life Science sector to identify, manage, and respond to risks while accelerating performance and maintaining growth. Help clients align risk and business objectives from strategy to execution and improving coordination of risk activities across the organization. Advise clients in business processes development, systems design and implementation assess risk and regulatory compliance with FDA and similar regulatory bodies. Help Life Sciences clients in the design and execution of Quality Management Systems (QMS) and Regulatory processes. Perform computer systems validation activities as part of a service. Perform Quality audits of client processes within the QMS area. Provide advisory services in compliance and regulations; quality management processes; FDA and other regulatory interactions; management of compliance process for supply chain, manufacturing, commercial operations and R&D. Analyze various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure. Manage and motivate teams of professionals with diverse skills and backgrounds. Consistently deliver quality client services by monitoring progress. Demonstrate in-depth technical capabilities and professional knowledge. Maintain long-term client relationships and networks. Cultivate business development opportunities.

Requirements

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.
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.
4 years of Life Sciences advisory, consulting, or industry experience including all of the following: Experience working with Life Science regulatory statutes; Experience working with GxP business processes and system validations; Experience with implementation of digital validation lifecycle management systems; and Experience with IT Quality or Business Quality Risk Management functions.
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.
3 years of experience with 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.
2 years of experience in managing and supervising teams of risk quality and compliance professional employees and mentoring team members through development feedback and performance processes, and providing structured, on-the-job feedback.
2 years of experience leading workshops and client-facing presentations.
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.

Nice To Haves

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.

Responsibilities

Assist clients in the Life Science sector to identify, manage, and respond to risks while accelerating performance and maintaining growth.
Help clients align risk and business objectives from strategy to execution and improving coordination of risk activities across the organization.
Advise clients in business processes development, systems design and implementation assess risk and regulatory compliance with FDA and similar regulatory bodies.
Help Life Sciences clients in the design and execution of Quality Management Systems (QMS) and Regulatory processes.
Perform computer systems validation activities as part of a service.
Perform Quality audits of client processes within the QMS area.
Provide advisory services in compliance and regulations; quality management processes; FDA and other regulatory interactions; management of compliance process for supply chain, manufacturing, commercial operations and R&D.
Analyze various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure.
Manage and motivate teams of professionals with diverse skills and backgrounds.
Consistently deliver quality client services by monitoring progress.
Demonstrate in-depth technical capabilities and professional knowledge.
Maintain long-term client relationships and networks.
Cultivate business development opportunities.