Sutro is seeking a senior professional to support our Quality Organization. This individual 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 the external supply chain, which includes custom reagents, XtractCFTM, antibody intermediate, drug substance and drug product manufacturing. This individual will also be responsible to support QS strategies to establish a robust cGMP facility in San Carlos, CA, as needed.
The Sr. Manager/Associate Director, Quality Assurance supports Quality System operations by managing QS projects/tasks with minimum guidance and in accordance with current GMPs. The Sr. Manager/Associate Director, Quality Assurance is a hands-on senior QA professional proven to perform both tactical and strategic tasks. The Sr. Manager/Associate Director, Quality Assurance will report to the Executive Director, Quality.
This individual will be responsible for supporting external supply chain cGMP operations at Sutro Biopharma’s and internal cGMP Operations as needed and will, at a minimum, include:
- Implement QS strategies in support of cGMP manufacturing at San Carlos Mfg. facility.
- Actively support the development, implementation, and maintenance of Sutro quality management systems and activities.
- 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.
- Provide QA support during manufacturing operations, which may include shift coverage.
- Support Contract Manufacturing Operations as QA Person-In-Plant. Support QA Management with various projects, as needed.
- Develop, apply, revise and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.
- Design methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- May assure compliance to in-house and/or external specifications and standards, (i.e. GLP, GMP, ISO, Six Sigma).
- May specialize in function specifically as it applies to biological licensing agreements.
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%.
- 8+ years of Quality Assurance/Quality Systems related experience in a cGMP biologics regulated manufacturing environment is required.
- 5+ years of solid management experience, is preferred
- Bachelor’s degree or higher in a relevant scientific area is strongly preferred.
- Relevant Quality Systems experience including Supplier and CMO/CTO/CRO Management, Change Control, Documentation Control, Training and Release.
- Skilled in evaluating and implementing solutions for regulatory compliance guidelines.
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- Knowledge and ability to sufficiently train others on regulatory compliance issues.
- Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner.
- Balanced decision making that demonstrates critical thinking.
- Able to establish priorities and maintain progress even under uncertain circumstances.
- Strong verbal and written communication skills essential.
- Strong communication, prioritization and organizational skills.
- Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
- Ability to utilize multiple word-processing and database applications.