Risk Adv - Business Cons - Risk Quality and Reg Comp - Life Sci - Senior Manager - Mul Pos - 1701461

denkstatt и EY•Tampa, FL

16h•Hybrid

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) (Senior Manager) (Multiple Positions) (1701461), Ernst & Young U.S. LLP, Tampa, FL. Lead advisory engagement teams to assist clients in the Life Science sector to identify, manage, and respond to risks while accelerating performance and maintaining growth. Advise clients to 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. Oversee advisory engagement teams to 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. Lead and direct teams of professionals with diverse skills and backgrounds by providing constructive on-the-job feedback/coaching to team members. Develop and maintain long-term client relationships and networks. Manage risk in the delivery of quality client services. Generate and manage new business 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 8 years of related regulatory life sciences compliance experience (of which 5 years must be progressive, post-baccalaureate work experience).
Alternatively, will accept a Master’s degree in Pharmacy, Biology, Chemistry, Biomedical Engineering, Quality Engineering, Manufacturing, Information Technology or a related field and 7 years of related regulatory life sciences compliance work experience.
Must have 7 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 7 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 6 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 5 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 5 years of experience leading workshops and client-facing presentations.
Must have 4 years 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 have or 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

Lead advisory engagement teams to assist clients in the Life Science sector to identify, manage, and respond to risks while accelerating performance and maintaining growth.
Advise clients to 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.
Oversee advisory engagement teams to 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.
Lead and direct teams of professionals with diverse skills and backgrounds by providing constructive on-the-job feedback/coaching to team members.
Develop and maintain long-term client relationships and networks.
Manage risk in the delivery of quality client services.
Generate and manage new business opportunities.

Benefits

We offer a comprehensive compensation and beneﬁts package where you’ll be rewarded based on your performance and recognized for the value you bring to the business.
The base salary for this job is $279,130.00 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.

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