Controls & Risk Lead, Transformation Projects

Title:                          Controls & Risk Lead, Transformation Projects

Job Number:             55513

Location:                   Tewksbury, MA or remote

Scope of Position:

The Control & Risk Lead, Transformation Projects is responsible for creating, deploying and managing the controls & risk program for transformation projects. In this role, he/she will plan and conduct internal control audits, manage the risk program and the change management process for the transformation program.

Day to Day Responsibilities:

• Assists in developing, deploying and managing the controls & risk program for transformation projects.
• Conducts internal control audits as part of the controls & risk program
• Oversees tracking of controls & risk nonconformances including follow up and closure
• Collaborates functionally and cross-functionally to meet organization objectives and initiatives
• Supports transformation projects for implementation of controls & risk processes
• Supports change management and document control for transformation program
• Provides direction and coaching to the transformation team regarding controls and risk
• Performs other related duties as assigned.

Travel Requirements:

• Up to 5%.

Hours of work/work schedule/flex-time:

• Monday – Friday, standard business hours
• Flexibility to support teams in Europe and Asia may be needed
• Job location is Tewksbury, MA or remote

Required Education:

• Bachelor’s degree in relevant field required.

Required Years and Area of Experience:

• Minimum of 5 years of experience in life sciences or medical device industry

Required Skills:

• Understanding and applying FDA’s Quality System Regulation and ISO 9001 and 13485 requirements for quality management systems, including leading and supporting audit program
• Ability to use tools to uncover root causes and implement corrective actions

• Proficient in basic information technology tools including MS Word, Excel, PowerPoint
• Effective written and verbal communication skills across all levels of the organization
• Must be an effective communicator, and able to deliver messages through presentations, written and verbal communication

• Knowledge of LEAN, Six Sigma and statistical process control
• Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision
• Ability to handle multiple tasks concurrently and in a timely fashion
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals
• Must display eagerness to learn and continuously improve
• Positive work attitude that supports teamwork and continuous improvement

Desired Experience / Qualifications / Skills:

• Experience with ERP (PeopleSoft, SAP, etc.) highly desired.
• Experience with project management highly desired

This position does not support immigration sponsorship.

Pay Grade: Grade C