Regulatory Compliance - Quality Transformation - Manager - Life Sciences

Our clients operate in a world where achieving high performance is just as important as the patients they serve. EY’s Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting their organization’s performance and impacting patient safety.

 

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 leading client engagement teams to deliver projects in the life sciences domain, including:

• Overseeing and directing the implementation of QMS, DMS, Safety, LIMS, and RIM systems (such as Veeva, Trackwise, EtQ Reliance, Argus, Calyx), ensuring effective collaboration across business process analysis, technical documentation, project management, computer systems validation, and other delivery and execution functions.
• Leading teams in the implementation of validation lifecycle management systems (including ValGenesis and Kneat), setting strategic direction and ensuring successful project delivery.
• Managing the design and execution of QMS and Regulatory processes, providing guidance and oversight to project teams to achieve compliance and operational excellence.
• Supervising the performance of computer systems validation activities, allocating resources, and ensuring adherence to industry standards as part of client service delivery.
• Coordinating and overseeing Quality audits of client processes within the QMS domain, ensuring comprehensive evaluation and actionable reporting.

 

You will also be expected to lead teams in consistently delivering high-quality client services by leveraging your extensive technical expertise and professional knowledge. In addition, you will be responsible for nurturing and maintaining long-term client relationships, ensuring a strategic and collaborative approach to project delivery.

 

Skills and attributes for success

• Performing large-scale implementations with consistent high quality delivery
• Driving high-quality work products within expected timeframes and on budget
• Ability to monitor progress, manage risk, and ensure key stakeholders are kept informed about progress and expected outcomes
• 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 5 years of related work experience.
• 5+ 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 implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems
• Travel required up to 40%.

           

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.