Overview:
We are seeking a Senior Manager or Associate Director of Quality Systems to oversee our Quality Systems and serve as the primary System Administrator for Veeva Quality Documents and Training applications. This role will support the execution of GxP quality activities, including the creation and management of document change control processes via Veeva, standard operating procedures (SOPs), GxP record processing and archival, offsite record storage, and employee training through Veeva Training. The individual will also support deviation, CAPA, and Change Control programs, manage our GxP vendor management program, oversee GxP computer systems, and generate quality metric reports. Daily responsibilities will encompass document control, training, and Quality Management System (QMS) activities.
Key Responsibilities:
- Maintain Quality Systems documentation within the Veeva eDMS.
- Manage eDMS activities as needed.
- Lead implementation efforts for new Veeva systems.
- Maintain document trackers and indexes for GxP systems.
- Collaborate with functional area representatives to develop, update, and maintain SOPs.
- Process and archive GxP records efficiently.
- Administer GxP training, manage the training matrix, and maintain employee training records in Veeva.
- Provide general support for the overall Quality System.
- Continuously improve the supplier qualification and evaluation program, including Quality Agreements.
- Prepare quality status reports for management reviews.
- Act as the primary contact for GxP computer system validation and change control.
- Manage and organize documents for offsite storage.
- Improve GxP document templates used throughout Veeva.
Qualifications:
- Bachelor’s degree in Life Sciences or a related field, or a combination of education and experience.
- Minimum of 5 years of experience with eDMS or eLMS in a pharmaceutical cGxP environment.
- Experience with Veeva Vault (superuser or Veeva Business Admin); trained System Administrator preferred.
- Proficiency in MS Office and general computer skills.
- Experience working with and formatting a variety of file types.
