Senior Manager Quality Systems Compliance
- San Francisco Bay Area
- Lucrative equity provided
A rapidly expanding biotech in SF is actively looking for a driven Quality Compliance individual seeking the next level of growth.
This company is expected to launch their first commercial product in the near future, which has created numerous new positions within the quality function. This role will assume ownership over the QMS and directly work with stakeholders to ensure GMP compliance throughout the organization. This position has vast exposure to senior leadership allowing tremendous ability to impact the organization and grow quickly.
Looking for a growth-minded expert in GMP compliance who is looking to be the architect in establishing and improving the QMS.
Responsibilities:
- Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, IQ/OQ/PQ etc.
- Develop department SOPs and provide SOP review for new systems
- Perform scheduled reviews of existing GxP systems and delineate remediation plans for non-conformances
- Maintain GxP Systems records and updates
