Senior Quality Assurance Specialist, Quality Systems & Compliance
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.
We are seeking a professional to be part of the Quality Systems & Compliance group. This group is responsible for establishing/updating/executing cGMP Quality Systems & Compliance activities including Documentation Control, Training and Compliance in support of reagents, XtractCFTM and XpressCFTMmaterial manufacturing. This individual will be assisting Quality Organization strategies to establish a robust cGMP facility in San Carlos, CA.
The Senior Quality Assurance Specialist is also a hands-on QA professional capable of performing tactical tasks. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.
This individual will be responsible for supporting Quality Systems (QS) in Sutro Biopharma’s cGMP Manufacturing Facility and will, at a minimum, include:
- Drive initiation, execution, closure and trending of Documentation Control, Training and Compliance activities in support of San Carlos Manufacturing Operations.
- Subject Matter Expert (SME) on Documentation Control platforms such as Master Control to drive efficiency and maximum utilization of the system.
- Conducting Quality reviews of production documentation, including production batch records, analytical records, and any supporting documentation to ensure compliance with cGMPs and Sutro policies and procedures.
- Providing QA support during manufacturing operations, which may include shift coverage.
- Assist with investigation and resolution of cGMP or procedural compliance gaps, as well as work with staff from other departments to resolve compliance issues found during the Quality reviews.
- Assist with training of personnel, to ensure compliance and conformance to Sutro’s requirements.
- Assist with Quality audits of internal departments, as well as support partner and/or regulatory authority audits.
- Develops, applies, revises, and maintains quality system protocols/methods/procedures.
- Perform cGMP documentation issuance, reconciliation, and archival according to policies and procedures.
- Performs 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 assist/support in Quality Operations activities including processing change controls, deviations and CAPAs.
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 Quality Systems and/or Compliance initiatives. Anticipated travel is minimal from 0-10%.
- 3-5 years of Quality Assurance/Quality Systems and/or Compliance related experience in a cGMP regulated manufacturing environment is required.
- Bachelor’s degree or higher in a relevant scientific area is strongly preferred
- Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- Results self-driven with a “can do” positive attitude
- Knowledge and ability to sufficiently train others on regulatory compliance issues
- Strong interpersonal skills and ability to work with others in a positive and collaborative manner
- Strong verbal and written communication skills essential
- Strong communication, prioritization, and organizational skills
- Knowledge of cGMP concepts and guidelines, as well as good documentation practices
- Ability to utilize multiple word-processing and database applications. Experience with contract manufacturing operations is a plus.
Sound exciting? Apply today and join our team!
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.
Please be advised, inquiries or resumes from recruiters will not be accepted.