Ernst & Young Oman
Senior Consultant - Digital Quality Transformation in Life Sciences
Ernst & Young Oman, Houston, Texas, United States, 77246
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Our clients in the Life Sciences sector are focused on achieving high performance and ensuring patient safety. As part of EY’s Life Sciences team, you will advise clients on strategic decisions that address risks impacting their organizational performance.
The Opportunity
As a key player in our Life Sciences Risk Consulting Services team, you will work closely with biotechnology, pharmaceutical, and medical technology organizations. Your role will involve helping clients identify, manage, and respond to operational risks while fostering performance and sustaining growth. You will advise on aligning risk and business objectives and improving risk activity coordination. Key areas of focus will include:
Quality Management Systems (QMS) including complaint management, CAPAs, deviations, change control, quality audits, and supplier quality management.
Regulatory Affairs including regulatory submissions and Health Registration Management.
Laboratory Information Management Systems (LIMS).
Computer Systems Validation in accordance with GxP requirements.
Your responsibilities will also extend to managing Quality business processes for supply chain, manufacturing, commercial operations, and R&D, including analyzing regulatory compliance with cGMP and 21 CFR Part 11 regulations. Your Key Responsibilities Support client engagement teams in delivering life sciences projects.
Implement QMS, DMS, Safety, LIMS, and RIM systems (e.g., Veeva, Trackwise) across various roles such as business process analyst, technical writer, project manager, and systems validation.
Design and execute QMS and Regulatory processes.
Carry out computer systems validation services.
Conduct quality audits of client QMS processes.
You will deliver quality client services, demonstrate deep technical expertise, and maintain lasting client relationships. This position requires full-time commitment and travel up to 40%. Skills and Attributes for Success Experience in large-scale implementations with a focus on quality delivery.
Ability to deliver high-quality work product on time and within budget.
Competence in managing risks and keeping stakeholders informed.
Awareness of current industry trends relevant to clients.
Strong collaboration skills with diverse teams.
Capability to foster an innovative and inclusive team environment.
Demonstrated professional knowledge and technical skills.
Qualifications Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing, or a related field, with at least three years of relevant experience.
Minimum of three years of Life Sciences experience, including knowledge of Life Science regulatory statutes, GxP processes, and risk management programs.
Ideally, you'll also have Experience implementing Veeva Vaults, LIMS, or Validation Lifecycle Management Systems. What We Look For We seek passionate leaders with strong delivery capabilities who are committed to staying updated on life sciences trends. If you have a passion for helping businesses drive value while serving patients, this role is for you. What We Offer You At EY, we invest in your development through future-focused skills and world-class experiences. You will work in a flexible environment that celebrates your unique talents in a diverse, inclusive culture. We provide a robust compensation and benefits package, including medical and dental coverage, pension and 401(k) plans, and various paid time off options. This position may require working together in person 40-60% of the time based on project needs. Are You Ready to Shape Your Future with Confidence? Apply Today. We encourage applicants to apply continuously. EY adheres to high ethical standards and integrity, expecting all candidates to embody these qualities. EY | Building a Better Working World At EY, we aim to create new value while building trust in capital markets. Our teams, supported by data and technology, help clients address their most pressing challenges. EY is an equal opportunity employer and is committed to providing reasonable accommodations for individuals with disabilities during the application process.
Regulatory Affairs including regulatory submissions and Health Registration Management.
Laboratory Information Management Systems (LIMS).
Computer Systems Validation in accordance with GxP requirements.
Your responsibilities will also extend to managing Quality business processes for supply chain, manufacturing, commercial operations, and R&D, including analyzing regulatory compliance with cGMP and 21 CFR Part 11 regulations. Your Key Responsibilities Support client engagement teams in delivering life sciences projects.
Implement QMS, DMS, Safety, LIMS, and RIM systems (e.g., Veeva, Trackwise) across various roles such as business process analyst, technical writer, project manager, and systems validation.
Design and execute QMS and Regulatory processes.
Carry out computer systems validation services.
Conduct quality audits of client QMS processes.
You will deliver quality client services, demonstrate deep technical expertise, and maintain lasting client relationships. This position requires full-time commitment and travel up to 40%. Skills and Attributes for Success Experience in large-scale implementations with a focus on quality delivery.
Ability to deliver high-quality work product on time and within budget.
Competence in managing risks and keeping stakeholders informed.
Awareness of current industry trends relevant to clients.
Strong collaboration skills with diverse teams.
Capability to foster an innovative and inclusive team environment.
Demonstrated professional knowledge and technical skills.
Qualifications Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing, or a related field, with at least three years of relevant experience.
Minimum of three years of Life Sciences experience, including knowledge of Life Science regulatory statutes, GxP processes, and risk management programs.
Ideally, you'll also have Experience implementing Veeva Vaults, LIMS, or Validation Lifecycle Management Systems. What We Look For We seek passionate leaders with strong delivery capabilities who are committed to staying updated on life sciences trends. If you have a passion for helping businesses drive value while serving patients, this role is for you. What We Offer You At EY, we invest in your development through future-focused skills and world-class experiences. You will work in a flexible environment that celebrates your unique talents in a diverse, inclusive culture. We provide a robust compensation and benefits package, including medical and dental coverage, pension and 401(k) plans, and various paid time off options. This position may require working together in person 40-60% of the time based on project needs. Are You Ready to Shape Your Future with Confidence? Apply Today. We encourage applicants to apply continuously. EY adheres to high ethical standards and integrity, expecting all candidates to embody these qualities. EY | Building a Better Working World At EY, we aim to create new value while building trust in capital markets. Our teams, supported by data and technology, help clients address their most pressing challenges. EY is an equal opportunity employer and is committed to providing reasonable accommodations for individuals with disabilities during the application process.