This role involves managing the day-to-day activities for Document Control and GxP Training programs, ensuring processes are completed accurately and on time through cross-functional collaboration. Key duties include managing the full document lifecycle, administering training within the LMS (ComplianceWire), and supporting broader quality system activities.
Requirements summary
Candidates must possess a Bachelor's degree or higher in a scientific discipline along with a minimum of 3 years of relevant experience in a regulated environment, preferably in QA. Essential knowledge includes Good Documentation Practices, ALCOA, and pharmaceutical regulations (FDA, ICH), alongside experience administering LMS platforms like ComplianceWire.
bachelor degreeRegulatory ComplianceContinuous ImprovementData IntegrityCross-functional CollaborationQuality Metrics ReportingMicrosoft Office Suite ProficiencyCAPA SupportDocument Control ManagementAdobe Acrobat ProficiencyAudits and InspectionsDocument Lifecycle ManagementGxP TrainingElectronic Learning Management System (LMS)ComplianceWire AdministrationChange Control Support
Job description
The opportunity
The Quality Assurance team is seeking a Senior Associate, Quality Assurance, to help optimize the quality systems and programs. In this role, you will manage the day-to-day activities related to the Document Control and GxP Training programs. This position requires cross-functional collaboration to ensure processes are completed accurately and within established timelines, while identifying opportunities to improve efficiency. This position will report to the Senior QA Manager.
The impact you’ll have
Document Control Management
Collaborate closely with stakeholders to develop, format, and maintain controlled documents and templates.
Execute activities across the full document lifecycle management including creation, routing, review, approval, periodic review, and archiving to ensure completion, compliance and data integrity.
Administer documentation (paper and electronic) issuance, reconciliation, and retention activities and ensure proper archiving practices and efficient retrieval processes.
Troubleshoot document-related issues within Microsoft Office applications (e.g., Word, Excel) and PDF software (e.g., Adobe Acrobat).
Training Program
Contribute to GxP training initiatives across the organization, acting as a Subject Matter Expert (SME) for the training program.
Ensure user roles, curriculum, and training items are developed, maintained, and assigned appropriately within the electronic Learning Management System (ComplianceWire).
Participate in ComplianceWire maintenance and validation activities such as executing user test scripts during changes to the system.
Monitor system performance, address technical issues and users need promptly to maintain system integrity and process efficiency.
Coordinate onboarding activities of new GxP employees such as conducting training sessions and assigning training in a timely manner.
QA Support and Continuous Improvement
Collaborate with QA and other stakeholders to support documentation, training, and quality system needs.
Assist with deviations, CAPAs, change controls, and other quality system activities, as assigned.
Benefits
Dental Insurance
Vision Insurance
Medical Insurance
401(k) Program With Employer Match
Mental Health Offerings
Equity Incentive Plan
Generous Holiday And PTO Policy
Participate in onsite audits and regulatory or client inspections, including preparation and readiness of documentation and training records.
Contribute to continuous improvement initiatives related to quality systems, document management, and training processes.
Manage tracking and reporting activities, related to.quality metrics
Actively contributes to a collaborative and compliant quality culture.
Perform other related duties as assigned to support QA operations.
What we’re looking for
Bachelor’s degree or higher in a scientific discipline with 3+ years of relevant experience in a regulated environment, preferably in QA.
Knowledge of Good Documentation Practices, ALCOA, and FDA, ICH, and international pharmaceutical regulations and guidelines.
Experience supporting document management and/or GxP training activities.
Experience administering ComplianceWire or other electronic Learning Management Systems.
Proficiency with Microsoft Office Suite (e.g., Word, Excel) and commonly used quality support tools (e.g., Adobe Acrobat, SharePoint, Docusign).
Experience with implementation and validation of an eQMS system for document management and/or quality processes is a plus.
Demonstrated ability to work independently and collaboratively with cross-functional stakeholders.
Attention to detail with effective organizational and time management abilities.
Written and verbal communication skills applicable to regulated documentation and cross‑functional coordination.
This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week.
About maze therapeutics
Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco.
Our people
Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
Our core values
Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.
Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.
Stand True – Our integrity is foundational; it guides us no matter the obstacle.
The expected annual salary range for employees located in the San Francisco Bay Area is $126,000 - $154,000. Additionally, this position is eligible for an annual performance bonus.
Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.
Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.
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