Manager, External Quality Assurance
Sutro is actively pursuing a dynamic Quality customer-focused professional with working experience on Supplier and CMO/CTO Management, Change Control, Documentation Control, Training and Release.
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:
- Conduct Material supplier qualification process to assure potential and/or current vendors and contract organizations which provide materials are acceptable for use by Sutro.
- Conduct GMP Service Provider qualification process to assure potential and/or current GMP Service Providers are acceptable for use by Sutro.
- Conduct Vendor Notification evaluations to assure potential and/or current Vendor organizations are acceptable for use by Sutro.
- Drive the completion and maintenance of CMO/CTO Quality Agreements.
- Manage the Supplier Management Review forum incorporating key stakeholders of Materials and Logistics, Manufacturing, Process and Analytical Development and Quality.
- Maintain an accurate list of all Qualified Suppliers, Vendors, GMP Service Providers in support of Sutro San Carlos and External Operations.
- Actively support the development, implementation, and maintenance of Sutro quality management systems, applicable SOP’s and qualification 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.
- 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%.
- 4+ years of Quality Assurance/Quality Systems related experience in a cGMP biologics regulated manufacturing environment is required.
- Possess a working knowledge of 21 CFR FDA, EU and ICH guidelines
- Bachelor’s degree or higher in a relevant scientific area is strongly preferred.
- Relevant Quality Systems experience including Supplier and CMO/CTO 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.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.
Please be advised, inquiries or resumes from recruiters will not be accepted.