Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Development team as we change the future of oncology. 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 role will be responsible for the development, management, and execution of the GCP QA programs to ensure that all aspects of the drug development process are in accordance with all relevant current FDA and international regulatory guidelines as they pertain to CTI product candidates. The position will also lead all Clinical QA aspects of NDA/MAA/BLA submissions including the development of internal and external audits and training necessary to ensure compliance across the company, and in preparation for all Pre-Approval Inspections (PAI). Reporting to the Chief Medical Officer, this role will partner very closely with Sutro’s Quality group. This position is located at Sutro’s headquarters in South San Francisco, California.
- Design and implement the GCP QA strategy and policies
- Lead the development of Clinical Development SOPs and ensure that SOPs are up to date and in accordance with internal policies and current external regulatory requirements
- Develop and implement all essential GCP training (incl. SOPs, external regulations and guidelines) for internal teams and external Contract Service Providers, where relevant
- Lead development of GCP Inspection Readiness efforts, ensure implementation and prepare internal teams for Pre-Approval Inspections (PAI)
- Monitor GCP non-conformance trends across the entire Clinical Development portfolio and communicate this information to management with proposed remediation actions
- Serve as the Clinical Quality expert for internal teams and provide guidance on and interpretation of global GCP regulations and standards
- Identify and drive continues clinical quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations
- Oversee vendor and Contract Service Providers audits, deviations and Corrective Action Preventative Actions (CAPAs)
- Lead/oversee Clinical Trial vendor qualification audits
- Perform all GCP metrics tracking and reporting
- Supports overall Sutro Quality goals and objectives and partners closely with the internal Quality group
- Collaborate with relevant internal departments on Computer Systems Validation (CSV) projects
- Source additional Clinical QA personnel or vendors as needed
- Serve as the primary point of contact for Clinical Development controlled documents (i.e. SOPs, etc.) and Clinical Development staff training and as the subject matter expert for these topics during audits and inspections
- Lead Clinical QA activities during preparation, conduct, and follow-up for Regulatory Agency inspections and internal audits
- Strong leadership and motivational skills with demonstrated ability to effectively lead teams to achieve the established goals within the expected time frames
- Demonstrated ability to influence internal and external stakeholders
- Strong organizational and communication skills
- Ability to prioritize and work independently and adapt to changing environment
- Excellent management and interpersonal skills with the ability to create a team environment
- Ability to interact cross-departments at all levels within Sutro and externally with vendors, consultants/contractors
- Operate and cooperate at all levels within a project, from oversight to hands-on management of day-to-day activities
- 15+ years of clinical quality assurance experience in pharmaceutical and/or biopharmaceutical product development or equivalent required
- 7+ years in a Clinical QA leadership position required
- Prior experience as the Lead QA individual responsible for NDA approval processes
- Experience with hosting Pre-Approval Inspections, planning and execution
- Must have broad GCP audit and compliance experience with direct oversight for CTI Operations and Contract Service Providers
- Experience leading business process improvement projects
- Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R2)
- Familiarity with 21 CFR Part 11 electronic systems and compliance activities required
- Bachelor’s Degree in life sciences or equivalentForeign regulatory and quality experience a plus
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. requires all colleagues 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.
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.
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 $275,000 – $300,000. 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.
About Sutro Biopharma
Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.