Synthego · 4 months ago
Quality Assurance Manager
Redwood City, CA
Full-time
Onsite
Mid Level
$102K/yr - $135K/yrSynthego is seeking a Quality Assurance Manager to join their Quality organization. This hands-on role involves managing eQMS GMP processes, leading risk management initiatives, and providing oversight for quality compliance across the organization.
Artificial Intelligence (AI)BiotechnologyGeneticsIndustrial AutomationInnovation ManagementLife ScienceMachine LearningSoftware
Responsibilities
Provide oversight of the eQMS and GMP processes and alignment by maintaining the QA programs, policies, and procedures to ensure GMP compliance of all Synthego products
Quality oversight responsibilities including deviation management, corrective and preventive action plans with interdepartmental teams and vendors to resolve potential product quality issues and escalation to senior management as appropriate
Lead the raw materials management that includes review and approval of raw materials and associated deviations/supplier corrective action requests
Lead the generation, review and/or approval of master batch records, stability study protocols/reports, specifications, deviations, etc
Assess and revise, as needed SOPs for GMP Quality functions and identify opportunities to streamline systems and processes
Collaborate with cross-functional teams to implement robust Corrective and Preventive Actions (CAPA), customer complaints, process change control management, Non-Conformance, Validation Master Plan, Risk Management, and Planned Deviation
Provide Quality guidance of cGMP for cross-functional groups to ensure compliance with KPI targets including functional QA as required
Provide Quality support for robust and transparent Quality Governance review processes such as Material Review Board (MRB) and Complaint Review Board (CRB)
Support and manage regulatory inspections and Notified Body audits as subject matter expert (SME)
Promote a Culture of Quality by providing support for the implementation of other quality systems, including department and corporate procedures, to ensure compliance with GMPS, other applicable regulations and standards
Support Quality Control activities in reviewing and approving protocol reports for method validation and stability Study
Manage Quality Assurance team and support professional development of the team members
Represent Quality Assurance in cross-functional meetings and/or projects
Other duties as assigned
Qualification
Required
Bachelor's degree in Biotechnology or Life Sciences
7 months experience as a Quality Control Specialist or Laboratory Manager
Benefits
Medical, dental, and vision benefits
401k Program
Paid parental leave
Flexible paid time off
Company
Synthego
Synthego is a genome engineering company that enables access to CRISPR to accelerate life science research and development.
Founded in 2012
51-200 employees
H1B Sponsorship
Synthego has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (3)
2022 (19)
2021 (13)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
$459.69MKey Investors
Perceptive AdvisorsFounders Fund8VC
2025-06-26Acquired
2022-02-17Series E· $200M
2020-08-26Series D· $100M
Leadership Team
Craig Christianson
President and CEO
Kevin Holden
Lead Scientific Advisor
Recent News
2025-07-22
Company data provided by crunchbase