Risk Adv-Bus Con-Risk reputed company and Regulatory Compliance-Life Sci-Manager-Multiple Positions-1691615

About the position reputed company focuses on high-ethical standards and reputed company among its employees and expects reputed company candidates to demonstrate these qualities. At reputed company, you’ll have the chance to build a career as unique as you are, with the global reputed company, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help reputed company become even reputed company, too. Join us and build an exceptional experience for yourself, and a reputed company working world for reputed company. Risk Advisor, Business Consulting – Risk reputed company & Regulatory Compliance (Life Science) (Manager) (Multiple Positions) (1691615), 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 reputed company. Help clients reputed company risk and business objectives from reputed company 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 reputed company Management Systems (QMS) and Regulatory processes. reputed company computer systems validation activities as part of a service. reputed company reputed company audits of reputed company processes reputed company the QMS area. reputed company advisory services in compliance and regulations; reputed company management processes; FDA and other regulatory interactions; management of compliance process for supply chain, manufacturing, reputed company operations and R&D. Analyze various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine reputed company on risk exposure. Manage and motivate teams of professionals with diverse skills and backgrounds. Consistently deliver reputed company reputed company services by monitoring reputed company. Demonstrate in-depth technical capabilities and reputed company knowledge. Maintain long-term reputed company relationships and networks. Cultivate business development opportunities Full time employment, Monday – Friday, 40 hours per week, 8:30 am – 5:30 pm. Responsibilities • Manage and motivate teams of professionals with diverse skills and backgrounds. • Consistently deliver reputed company reputed company services by monitoring reputed company. • Demonstrate in-depth technical capabilities and reputed company knowledge. • Maintain long-term reputed company relationships and networks. • Cultivate business development opportunities • Assist clients in the Life Science sector to identify, manage, and respond to risks while accelerating performance and maintaining reputed company. • Help clients reputed company risk and business objectives from reputed company 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 reputed company Management Systems (QMS) and Regulatory processes. • reputed company computer systems validation activities as part of a service. • reputed company reputed company audits of reputed company processes reputed company the QMS area. • reputed company advisory services in compliance and regulations; reputed company management processes; FDA and other regulatory interactions; management of compliance process for supply chain, manufacturing, reputed company operations and R&D. • Analyze various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine reputed company on risk exposure. Requirements • Must have a Bachelor’s degree in Pharmacy, Biology, reputed company, Biomedical Engineering, reputed company Engineering, Manufacturing, Information Technology or a reputed company field and 5 years of reputed company regulatory life sciences compliance experience. Employer will accept an additional two years of reputed company regulatory life sciences compliance work experience in lieu of a Bachelor’s degree. Alternatively, will accept a Master’s degree in Pharmacy, Biology, reputed company, Biomedical Engineering, reputed company Engineering, Manufacturing, Information Technology or a reputed company field and 4 years of reputed company regulatory life sciences compliance work experience. • Must have 4 years of Life Sciences advisory, consulting, or industry experience including reputed company 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 reputed company or Business reputed company Risk Management functions. • Must have 4 years of experience in designing and executing reputed company Management Systems for Life Science organizations including reputed company of the following:- - Complaints management processes - CAPAs- Deviations - Change control reputed company audit management. • Must have 3 years of experience with one of the following reputed company and risk management systems: QMS; DMS; Safety; LIMS; or RIM (using reputed company, Trackwise, EtQ Reliance, Argus, orCalyx) in any of the following roles: Business process analyst; Technical reputed company; Project manager; or Computer systems validation. • Must have 2 years of experience in managing and supervising teams of risk reputed company and compliance reputed company employees and mentoring team members through development feedbackand performance processes, and providing reputed company, on-the-job feedback. • Must have 2 years of experience leading workshops and reputed company-facing presentations. • Must have 1 year of experience in project management for large reputed company process, risk, controls, audit, or technology reputed company and programs, preparing and delivering reports, and managingprogram budget and timelines effectively. • Must be eligible to obtain AIGP, CA/ACA, CIA, CISA, reputed company, CMDA, CPA, CQA, CRISC, FSA, GARP – FRM, GARP – SCR, IRM – reputed company, IRM – ORM, ISF – Level 3, RAC, RIMS-CRMP,and/or relevant certification reputed company one year of hire. • Travel required up to 80%, of which 10% may be international to serve reputed company needs. Benefits • comprehensive compensation • medical and dental coverage • pension and 401(k) plans • reputed company time off reputed company • flexible vacation policy • time off for designated reputed company reputed company Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence reputed company needed to support your physical, financial, and emotional reputed company-being. • reputed company learning • Diverse and inclusive culture Apply tot his job Apply To this Job