Sr. Manager/Associate Director, Quality Assurance
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We are seeking a professional to lead our Quality Systems (QS) group, which could potentially be expanding in scope and headcount over time. This group will be responsible for establishing/updating GMP quality systems including Supplier and CMO/CTO/CRO Management, Change Control, Documentation Control, Training and Release in support of reagents, extract and cell free material manufacturing. This individual will be responsible to drive QS strategies to establish a robust cGMP facility in San Carlos, CA.
The Quality Assurance Sr. Manager/ Associate Director leads Quality System operations by managing/directing and developing QS staff in performing a variety of tasks, with general guidance and in accordance with current GMPs. The Quality Assurance Sr. Manager/ Associate Director is also a hands-on QA professional capable of performing both tactical and strategic tasks.
This individual will be responsible for supporting cGMP operations in Sutro Biopharma s cGMP Manufacturing Facility and will, at a minimum, include:
Hire, Develop, Motivate and Lead the Quality Systems group.
Implement QS strategies in support of cGMP manufacturing at San Carlos Mfg. facility.
Lead the development, implementation, and maintenance of Sutro quality management systems and activities.
Act as management level QS liaison with Manufacturing, Quality Control and other appropriate organizations
Perform reviews of cGMP documentation, both at Sutro and contract organizations.
Review and approve completed batch documentation for cGMP production, including QC documentation of release and in-process testing.
Lead investigation and resolution of cGMP or procedural compliance failures, as well as work with staff from other departments to resolve compliance issues found during the Quality review.
Release raw materials and batches/lots for further manufacturing, clinical trials and commercial distribution.
Conduct supplier evaluations to assure potential and/or current vendors and contract organizations are acceptable for use by Sutro.
Perform Quality audits of potential and/or current vendors and contract organizations, as well as internal departments.
Oversee and perform training of personnel to ensure compliance and conformance to Sutro s requirements.
Manage and perform day-to-day activities of the Document Control, including creation and/or revision, processing, routing and releasing controlled documents.
This individual will be expected to effectively follow Sutro Biopharma s SOPs and policies, and cGMP compliance regulations. Additionally, he/she should be able to independently manage review times to meet Sutro s priorities and communicated timelines.
This individual may be asked to travel on behalf of Sutro Biopharma to support business operations that involve contract manufacturing. Anticipated travel is approximately 5-20%.