EY Risk Adv, Risk Ctrl Tech. Svcs(Life Sci Qlty & Comp.) Mgr (Multiple Positions) in Boston, Massachusetts
Risk Adv, Risk Ctrl Tech. Svcs(Life Sci Qlty & Comp.) Mgr (Multiple Positions)
Requisition # BOS002Z5
Post Date Sep 26, 2018
Risk Adv, Risk Ctrl Tech. Svcs(Life Sci Qlty & Comp.) Mgr (Multiple Positions), Ernst & Young U.S. LLP, Boston, MA.
Full job tile: Risk Advisor, Risk Control Technology Services (Life Sciences Quality & Compliance) (Manager) (Multiple Positions)
Improve business performance, quality operations, and drive enterprise transformational strategy for Life Sciences clients facing unique challenges from rapidly evolving health authority requirements in the Quality, Regulatory and Compliance functions. Assist in addressing key issues across R&D, supply chain, manufacturing and commercial operations, including strategies to optimize and transform quality management processes, compliance with existing and emerging health authority regulations both in the US (FDA) and globally, regulatory agency interactions, and management of quality and compliance processes. Help clients across multiple Quality & Compliance functional areas with strategy, process and organization optimization and management, technology enablement/implementation, growth strategy, and enterprise transformation. Deploy Quality & Compliance solutions that support regulatory compliance while supervising and managing local and global teams. Help clients implement a proficient design and effectively manage organizational change in their environment.
Manage and motivate teams 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.
Must have a Bachelor's degree in Pharmacy, Biotechnology, Bioengineering, Medical Technology, Biology, Chemistry, Engineering, Business or a related field and 5 years of progressive, post-baccalaureate related work experience. Alternatively, will accept a Master's degree in Pharmacy, Biotechnology, Bioengineering, Medical Technology, Biology, Chemistry, Engineering, Business or a related field and 4 years of related work experience
Must have 4 years of experience in delivering advisory or consulting services to Life Sciences clients, or in compliance within the Life Sciences industry
Must have 3 years of quality management system (QMS) experience working with applicable regulatory requirements including 21 CFR Parts 11, 210, 211, 610, and 820, and/or HIPAA
Must have 3 years of experience in project management, including accountability for schedules, deliverables, priorities and dependencies, progress updates, team management, and client service
Must have 2 years of experience in one or more of the following:
Quality and regulatory operations, developing, improving or remediating Quality management systems for Life Sciences organizations, performing or managing responses to health authority (e.g. FDA) observations, and implementing LIMS and other QMS systems
Developing cGxP audit plans, assessments and reports. Assessing, designing and implementing audit, risk management and/or compliance programs including risk governance, risk appetite and tolerance, risk-based strategic/business planning processes, and integration of risk management functions
Designing continuous process improvement frameworks, tools and templates, conducting root cause assessment, and defining corrective and preventative actions (CAPA) in GxP environment
Computerized System Validation (CSV) and testing in a validated environment, with hands-on experience with SDLC requirements, Agile or Waterfall methodologies, testing automation( Quality Center and/or ValGenesis), and tracking issues using JIRA
End-to-end management of clinical trials including: study design; study coordination; patient data acquisition and management; close out; external data management; regulatory reporting; and risk-based monitoring
Requires travel up to 80%, to serve client needs
Employer will accept any suitable combination of education, training or experience.
TO APPLY: Please apply on-line at ey.com/us/jobsearch (Job Number – BOS002Z5).
This particular position at Ernst & Young in the United States requires the qualified candidate to be a "United States worker" as defined by the U.S. Department of Labor regulations at 20 CFR 656.3. You can review this definition at https://www.gpo.gov/fdsys/pkg/CFR-2011-title20-vol3/pdf/CFR-2011-title20-vol3-sec656-3.pdf at the bottom of page 750. Please feel free to apply to other positions that do not require you to be a "U.S. worker".