Senior Manager, Quality Systems EnVivo Pharmaceuticals
Support ongoing Quality System (GXP) infrastructure build as well as managing new systems once developed including but not limited to:
Managing the training program
Assisting with completion of required SOPs
Managing the annual audit program
Conducting GXP audits, including but not limited to clinical documentation audits, internal compliance audits and external vendor audits as deemed necessary.
While main focus of efforts will be to support the GCP activities at EnVivo, support for the review of batch records, CoAs, and material release may also be required as work load dictates.
BS/BA in Life Sciences or equivalent with at least 7 years in GXP related positions is required.
Knowledge of current GXPs, including GCP, cGMP and GLP is required.
Good communication skills, both oral and written are necessary.
Ability to apply regulations to real world scenarios and ongoing drug development tasks in a manner to support efforts and colleagues is needed.
Previous experience with auditing of clinical documentation, handling deviations and CAPA reports, and managing compliance documentation is required.
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Watertown, MA 02472