Senior Director, Quality Operations (San Carlos, CA)
Sutro Biopharma, Inc. is looking for a strategic and experienced Senior Director of Quality Operations who will lead and influence all internal Quality Assurance aspects for GMP Operations at San Carlos in all phases of product development including commercialization. Primary function will be accountability for all internal Quality Assurance activities to support oversight and final release of Sutro and partner products. The ideal candidate has expertise on Quality Systems (QS) such as Training, Deviation Management, CAPA, Supplier Management and Documentation Control and more importantly the level of rigor required from phase 1 through commercialization. The candidate must be able to strategically define and drive a multi-year plan and priorities for the internal QA function, as well as mentor and develop the GMP skillset within the entire organization.
- Establish and drive strategy to ensure we are ready and compliant with late-stage Quality Assurance requirements including all Phase 2 and 3, EU including China.
- Accountable for internal Quality Operations including Product Release, Quality Systems, Compliance and Validation functions.
- Partner with QC and External QA Leadership to ensure compliance with regulatory requirements (end-to-end) from raw materials, reagents, cell free, drug substance, drug product and packaged drug product.
- Principal SME for QA sections of all Sutro regulatory submissions.
- Strategically establish a sustainable internal QA organization as evidenced by right-the-first time execution and independent technical and GMP capabilities.
- Establish credibility as the SME for all QA issues at Sutro Biopharma at the San Carlos Manufacturing facility.
- Lead all activities within QA to support release reagents, intermediates and drug substance manufactured at the San Carlos Manufacturing facility.
- CMC QA Representative for all San Carlos Manufacturing activities.
- Possess extensive auditing experience. Accountable for inspection readiness activities and represent/lead Sutro in inspections by regulatory agencies or partner companies.
- Work closely with QC, Manufacturing, Tech Transfer, Process & Analytical Development, Supply Chain, Regulatory Affairs and Alliance Management departments to ensure project timelines are met.
- Pro-actively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement in QA operations.
- Actively review GMP documents (protocols, reports, SOPs, special studies, etc.) as needed to support GMP manufacturing and product release.
- Accountable for End-to-End deviation/OOS investigations and implement CAPAs and change controls.
- Actively create and establish processes and procedures to ensure cGMP compliance and operational efficiency within QA.
- Communicate data both verbally at group meetings and through written documents and reports.
- BS or MS degree in Engineering, Chemistry or related field with working knowledge of Microbiology.
- 15+ years of with BS or 10+ years with MS in QA management experience in a cGMP biologics regulated manufacturing environment is required.
- Working knowledge of antibody drug conjugates and proteins is strongly preferred.
- Extensive experience establishing QA infrastructure and quality systems.
- Thorough knowledge on equipment qualification and process validation including computerized system validation.
- Expertise in ICH/USP/EP/JP guidelines as it relates to QC methods, validation, and stability.
- Natural leader by influence that can educate and earn the credibility of associates up, down and across the entire organization and outside of the organization.
- Capable of strategic thinking that drives critical thinking and prioritization in a dynamic environment with multiple priorities.
- Excellent customer facing capabilities.
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner.
- Excellent verbal and written communication skills essential.
- Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
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.
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.