Senior Quality Systems Engineer, Cell and Gene Therapies

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Philadelphia, United States Laguna Source Full time

This is an exciting opportunity to lead GxP Quality Systems within a promising Cell & Gene Therapy company revolutionizing cancer immunotherapies You'll be responsible for providing Quality Systems oversight and support for the development and operations of a commercial scale state-of-the-art cGMP cell therapy manufacturing and laboratory facilities. Your roles and responsibilities will include:

* Collaborating with cross-functional groups including Manufacturing, Quality Control, IT, Engineering, and Validation to identify risks, develop mitigation strategies, and resolve issues, ensuring the smooth functioning of Quality systems including TrackWise QMS, Veeva and Labware.

* Championing Data Integrity and Computer System Validation efforts, driving improvements throughout the system lifecycle.

* Spearheading cGMP quality improvement initiatives, both on-site and in remote facilities, to elevate our standards across the board.

* Crafting and maintaining essential company documentation such as quality manuals and procedures, ensuring clarity and compliance at every step.

* Serving as the voice of Quality on cross-functional teams, providing technical guidance and expertise to drive projects forward and implement system improvements.


Desired Skills & Experience

* BS degree in Biology, Chemistry, Biochemistry, Microbiology, Molecular Biology, Engineering, Computer Science or related Engineering or Life Sciences field.

* 5+ years of hands-on Quality Systems experience working within a Cell and Gene Therapy or Biologics manufacturing environment.

* Quality Systems proficiency working with GxP TrackWise QMS, Veeva, Labware, MODA, Empower and LabVantage or related Quality Systems.

* Experience preparing for and participating in manufacturing and laboratory regulatory inspections.

* Demonstrated proficiency in creating and utilizing inspection/testing systems, ensuring the highest standards of quality are met.

* Strong communication skills, both verbal and written, enabling effective collaboration with management and project team members.

This is a full-time permanent position offering a competitive Base Salary + Bonus + Stock Options as well as a comprehensive healthcare benefits package.

Company Description

This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.

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