Roles and Responsibilities:

• Lead a team of Quality Investigators performing the following activities.
• Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS).
• The Investigators in this role will be responsible for executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts, and overseeing CAPA's.
• They will also manage both minor and major investigations.
• Work on a team under a Senior Manager.
• The Lead Investigator will also be responsible for reporting to the client management on a weekly basis on investigative details, project progress and project metrics.

Must have experiences :

• Cell/Gene Therapy experience preferred.
• Experience in Batch Records Review

Job Type: Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Schedule:

• Day shift

Ability to Relocate:

• Baltimore, MD 21201: Relocate before starting work (Required)

Work Location: In person