Sutro Biopharma, Inc. is seeking a seasoned professional to support our Quality Organization. This individual will be responsible for establishing/updating GMP internal and external audit programs as well as Inspection Readiness in support of the San Carlos Manufacturing Facility as well as the external supply chain, which includes custom reagents, XtractCFTM, antibody intermediate, drug substance and drug product manufacturing. This individual will also be responsible to lead/drive Compliance strategies in support of the entire Sutro product portfolio.
The Manager/Sr. Manager, Compliance manages Compliance projects/tasks with minimum guidance and in accordance with current GMPs. The Manager/Sr. Manager, Compliance is a hands-on senior QA professional proven to perform both tactical and strategic tasks. The Manager/Sr. Manager, Compliance reports to the Executive Director, Quality.
This individual will be responsible for supporting internal and external supply chain cGMP operations at Sutro Biopharma’s as needed and will, at a minimum, include:
- Implement Compliance strategies in support of cGMP manufacturing at San Carlos Mfg. facility and external Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) and potentially Contract Research Organizations (CROs).
- Subject Matter Expert for Compliance including FDA, EU and International Regulations and Guidelines.
- Accountable for Inspection Readiness in support of Sutro’s entire product portfolio including managing the responses to GMP audit observations.
- Lead, implement and maintain Internal and External Audit Programs.
- Reviews and approves Technology Transfer (process and analytical) documentation and specifications in alignment with regulatory submissions.
- Reviews regulatory submissions such as INDs, CTAs and BLAs for accuracy.
- Perform reviews of cGMP documentation, both at Sutro and contract organizations.
- Perform Quality audits of potential and/or current vendors and contract organizations, as well as internal departments.
- Educates Sutro on regulatory compliance trends and establishes strategies to address new and upcoming regulations and guidelines.
- May perform training of personnel to ensure compliance and conformance to Sutro’s requirements.
- May conduct supplier evaluations to assure potential and/or current vendors and contract organizations are acceptable for use by Sutro.
- May support Contract Manufacturing Operations as QA Person-In-Plant. Support QA Management with various projects, as needed.
- May perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
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/Quality Systems/Compliance related experience in a cGMP biologics regulated manufacturing environment is required.
- 5+ years of solid exposure to Regulatory Inspections, Internal and External
- Bachelor’s degree or higher in a relevant scientific area is strongly preferred.
- Relevant Quality Systems experience including Supplier and CMO/CTO/CRO Management, Change Control, Documentation Control, Training and Release.
- Skilled in evaluating and implementing solutions for regulatory compliance guidelines.
- Exposure to INDs, CTAs and BLAs is preferred.
- 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.
- 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.
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.