Quality and Regulatory Systems Implementation -Manager-Consulting

The opportunity

The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry.

You will be an integral part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth.

Our team advises clients on aligning risk and business objectives from strategy to execution, and improving coordination of risk activities across the organization for better outcomes.

This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally :

Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.)

Regulatory Affairs (regulatory submissions, Health Registration Management, etc.)

Laboratory Information Management Systems

Computer Systems Validation (following a GxP system development lifecycle)

In addition, our team also works on projects with clients to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D.

This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure.

Your key responsibilities

Your time will be spent managing projects and engagement teams on the following project types :

Implementation of QMS, DMS, VLMS, Safety, LIMS, and RIM systems ( Veeva, Trackwise, ValGenesis, Kneat, EtQ Reliance, Argus, Calyx) as a workstream lead for Quality, regulatory, laboratory, Pharmacovigilance, and clinical business processes.

Design and execution of Quality Management and Laboratory of the future processes.

Leading service teams performing computer systems validation (onshore and offshore).

Performing Quality audits of client processes within the QMS area.

You will also be expected to lead client proposals and presentations on QMS and Laboratory processes by demonstrating in-depth technical capabilities and professional knowledge, and maintaining long-term client relationships.

Full time employment, Travel required up to 40%.

Skills and attributes for success

Leading large-scale implementations with consistent high quality delivery

Driving high-quality work products within expected timeframes and on budget

Reporting competency sales against goals on leadership visualization dashboards

Staying abreast of current industry trends relevant to the client’s business

Effectively working on teams with diverse skills and backgrounds

Fostering an innovative and inclusive team-oriented work environment

Demonstrating deep technical capabilities and professional knowledge

To qualify for the role you must have

A bachelor’s or master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least three years of related work experience.

6+ years of Life Sciences work experience, including working with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs or integration of risk management functions.

Ideally, you’ll also have

Experience in QMS, LIMS, RIM, and / or Validation Lifecycle Management Systems

What we look for

We are interested in passionate leaders with strong delivery capability, and a strong desire to stay on top of trends in the life sciences industry.

If you have a strong passion for helping businesses drive measurable value while serving patients, then this role is for you.

What we offer 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 salary range for this job in most geographic locations in the US is $100,000 to $183,300. The salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $120,000 to $208,300.

Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography.

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.

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.
30+ days ago