We're currently partnered with a a privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies. They're currently going through a growth period within their Quality department and one of their open positions, is a Sr Manager/Associate Dir, Quality Systems.
The Sr Manager/ Associate Dir, Quality Systems, will manage Quality Systems, act as the main System Administrator for Veeva Quality Documents and Training applications and assist in the execution of GXP quality activities, including but not limited to creation and processing of document change control documentation through Veeva, management of standard operating procedures (SOPs), GxP record processing and archival, offsite record storage, employee training via Veeva Training, support of deviation, CAPA, and Change Control programs, GxP vendor management program, management of GxP computer systems and generation of quality metric reports. The individual will be responsible for day-to-day document control, training, and QMS activities.
Education, Experience and Qualification Requirements:
- BA/BS in a Life Science or related field or a combination of experience and education
- Min 5 years’ Experience with eDMS and or eLMS in a pharmaceutical cGxP environment
- Experience with Veeva Vault (superuser or Veeva Business Admin), Trained System Administrator preferred
- Proficient with the computer (MS Office) and internet skills
- Experience working with and formatting many file types
