Risk Adv - Business Cons - Risk Qlty and Reg Comp - Life Science - Manager - Mul Pos - 1657015

Ernst & Young LLP • Raleigh, NC

60d

About The Position

EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities. 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. Risk Advisor, Business Consulting - Risk Quality & Regulatory Compliance (Life Science) (Manager) (Multiple Positions) (1657015), Ernst & Young U.S. LLP, Raleigh, NC. 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. Full time employment, Monday - Friday, 40 hours per week, 8:30 am - 5:30 pm.

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 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 working with GxP business processes and system validations
• Experience with implementation of digital validation lifecycle management systems
• Experience with IT Quality or Business Quality Risk Management functions.
• 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 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.
• Must have 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.
• 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.
• Travel required up to 80%, of which 10% may be international to serve client needs.
• Employer will accept any suitable combination of education, training or experience.

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.

Benefits

• comprehensive compensation and benefits package
• medical and dental coverage
• pension and 401(k) plans
• 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 when needed to support your physical, financial, and emotional well-being
• Continuous learning
• Success as defined by you
• Transformative leadership
• Diverse and inclusive culture

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees