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Quality Investigation Manager – Cell/Gene Therapy

3 months ago

Baltimore, United States Intellectt Inc Full time

Job Title: Quality Investigation Manager – Cell/Gene Therapy

Location: Baltimore, MD


Job Description:

We are seeking an experienced Quality Investigation Manager with over 10 years of experience in managing quality investigations within the Cell/Gene Therapy or Biologics sectors. The ideal candidate will have a strong background in handling Deviations, CAPAs, Non-Conformances, and Root Cause Analysis, with essential experience in TrackWise and other Quality Management Systems (QMS).


Key Responsibilities:

Execute and/or evaluate deviations, conduct interviews, analyze root causes, and assess impact.

Identify and implement corrective and preventive actions (CAPAs) to prevent recurrence.

Present findings and proposed actions to management and ensure timely closure of investigations in the QMS.

Own and author deviations, driving continuous improvement initiatives within the organization.

Manage both minor and major investigations, particularly those related to Batch Record reviews.

Collaborate with cross-functional teams and work under the guidance of a Senior Manager.


Qualifications:

8 to 10 years of experience in Quality Investigations, specifically in managing Deviations, CAPAs, Non-Conformances, and Root Cause Analysis.

Extensive experience in Cell/Gene Therapy or Biologics is required.

Proficiency in using TrackWise and other Quality Management Systems (QMS).

Strong analytical, problem-solving, and decision-making skills.

Excellent communication and presentation abilities.

Experience in driving continuous improvement efforts and managing both minor and major quality investigations.


Preferred Skills:

Ability to work effectively in a team environment under the supervision of a Senior Manager.

Experience in Batch Record reviews and related investigations.

Strong organizational skills with the ability to manage multiple tasks simultaneously.