Senior Manager, QA Lot Disposition – External (San Carlos, CA)
Sutro Biopharma, Inc. is looking for a dynamic quality customer-focused professional with working experience in the areas of: product lot release of externally produced products, qualification and management of raw material supplier and third-party organizations, leading the raw material review, board management of quality records management, documentation Control for externally produced products, project team participation, and leadership.
- Perform Lot Release Disposition of Externally produced Product
- Perform QA team leadership for specific product campaigns and team participation
- Coordinate with External Quality Assurance to compile and review all documentation to perform Quality Release of Externally produced Products
- Assist in the completion and maintenance of CMO/CTO Quality Agreements
- Actively support the development, implementation, and maintenance of Sutro quality management systems & applicable SOP’s
- 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
- Oversee and perform training of personnel to ensure compliance and conformance to Sutro’s requirements
- Develop, apply, revise, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products
- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary
- Participation in the ERP and Quality System implementation, training, and maintenance activities
- May ensure compliance to in-house and/or external specifications and standards, (i.e. GLP, GMP, ISO, Six Sigma)
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 5-10%.
- 6+ 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, Raw Material Review Board Team Management, Change Control, Documentation Control, Training and Raw Material/Final Product 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 pertaining to external requirements
- 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 are 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
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Sutro will consider requests for reasonable accommodations.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability, or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $175,000 – $200,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development, and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines, and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.