Risk Advisor, Business Consulting - Risk Transformation (Life Sciences Quality & Compliance) (Manager)(Multiple Positions)

Job description

Risk Advisor, Business Consulting - Risk Transformation (Life Sciences Quality & Compliance) (Manager) (Multiple Positions) , Ernst & Young U.S. LLP, Iselin, NJ.

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,40hours per week, 8:30 am – 5:30 pm

MINIMUM REQUIREMENTS:

 

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/en_us/careers, and click on “Find jobs” (Job Number – ISE001HK).

 

EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, national origin, protected veteran status, disability status, or any other legally protected basis, in accordance with applicable law.

 

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 athttps://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'.