Quality Assurance Associate Director/Director
Sutro is seeking a positive cross-functional influential leader for our Quality Assurance 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 QA strategies to establish a robust cGMP facility in San Carlos, CA and also ensure right level of quality oversight over an external supply chain.
The Quality Assurance Associate Director/Director leads Quality Assurance operations by managing/directing and developing QA staff in performing a variety of tasks, with general guidance and in accordance with phase-appropriate GMPs. The Quality Assurance Associate Director/Director is also a hands-on QA professional capable of performing both tactical and strategic tasks. It is paramount for this leader to exemplify a positive collaborative influence for the entire organization and also to be able to believe, adopt and drive risk-based cross-functional strategies in full alignment with current manufacturing phase and technical understanding of our products.
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 Assurance group.
- Implement QA 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 QA 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%.
- 8+ years of Quality Assurance related experience in a cGMP biologics regulated manufacturing environment is required.
- 5 + years of solid management experience (hiring and development), including management of QA professionals.
- Able to discern and establish systems according to phase appropriate GMP requirements following a risk management approach, as applicable.
- Skilled in evaluating and implementing solutions for regulatory compliance guidelines inclusive of distinguishing between raw materials, starting materials, intermediate, drug substance and drug product requirements.
- Relevant/Extensive Quality Systems experience including Supplier and CMO/CTO/CRO Management, Change Control, Documentation Control, Training and Release.
- Knowledge of cGMP concepts and guidelines, as well as good documentation practices.
- Bachelor’s degree or higher in a relevant scientific area is strongly preferred.
- Familiar with budgeting processes for projects, personnel, equipment and lab space.
- Familiarity with Quality Control, Validation and Technology Transfer both internally and through CMOs/CTOs.
- Ability to build cross-functional partnerships and capitalize on stakeholders diversity and perspectives, especially when making decisions.
- Capacity to develop his/her team to become effective, particularly on HOW the work is done, by educating and fostering a positive solution oriented mindset/approach.
- 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.
- 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.