Risk Adv - Business Con - Risk Quality and Reg Comp - Life Science - Manager - Mul Pos - 1638747

Ernst & Young • Woodbridge Township, NJ

131d • $188,178

About The Position

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better. Join us and build an exceptional experience for yourself, and a better working world for all. The exceptional EY experience. It's yours to build. As a Risk Advisor in Business Consulting - Risk Quality & Regulatory Compliance (Life Science), you will assist clients in the Life Science sector to identify, manage, and respond to risks while accelerating performance and maintaining growth. You will help clients align risk and business objectives from strategy to execution and improve coordination of risk activities across the organization. Your role will involve advising clients in business processes development, systems design and implementation, assessing risk and regulatory compliance with FDA and similar regulatory bodies. You will also help Life Sciences clients in the design and execution of Quality Management Systems (QMS) and Regulatory processes, perform computer systems validation activities, conduct quality audits of client processes, and provide advisory services in compliance and regulations.

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, or a Master's degree in the same fields with 4 years of related experience.
• 4 years of Life Sciences advisory, consulting, or industry experience including experience with Life Science regulatory statutes, GxP business processes, and system validations.
• 4 years of experience in designing and executing Quality Management Systems for Life Science organizations.
• 3 years of experience in quality and risk management systems such as QMS, DMS, Safety, LIMS, or RIM using Veeva, Trackwise, EtQ Reliance, Argus, or Calyx.
• 2 years of experience managing and supervising teams of risk quality and compliance professionals.
• 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.
• Eligibility to obtain relevant certifications within one year of hire.

Responsibilities

• Assist clients in the Life Science sector to identify, manage, and respond to risks.
• Help clients align risk and business objectives from strategy to execution.
• Advise clients in business processes development, systems design and implementation.
• Assess risk and regulatory compliance with FDA and similar regulatory bodies.
• Help clients design and execute Quality Management Systems (QMS) and Regulatory processes.
• Perform computer systems validation activities.
• Conduct quality audits of client processes within the QMS area.
• Provide advisory services in compliance and regulations, quality management processes, and FDA interactions.
• Analyze various cGMP and 21 CFR Part 11 regulations to determine impact on risk exposure.
• Manage and motivate teams of professionals with diverse skills and backgrounds.
• Deliver quality client services by monitoring progress.
• Maintain long-term client relationships and networks.
• Cultivate business development opportunities.

Benefits

• Comprehensive compensation and benefits package.
• Base salary of $188,178.00 per year.
• Medical and dental coverage.
• Pension and 401(k) plans.
• Wide range of paid time off options.
• Flexible vacation policy.
• Time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree