Avalo Therapeutics · 21 hours ago
Senior Manager, Quality Assurance Systems
Greater Philadelphia
Full-time
Hybrid
Senior Level
7+ years expAvalo Therapeutics is a clinical stage biotechnology company dedicated to developing treatments for immune-mediated inflammatory diseases. The Senior Manager, Quality Assurance Systems will lead the electronic Quality Management System (eQMS) to ensure compliance with internal procedures and global regulatory requirements, while overseeing document control, training metrics, and audit readiness.
BiotechnologyTherapeutics
Responsibilities
Serve as the system administrator for Veeva QMS
Ensure system configuration aligns with company needs and regulatory expectations
Manage user access, workflows, and periodic system updates
Oversee document lifecycle management including creation, revision, approval, and archival
Support staff in following SOPs and Work Instructions during document revisions
Provide guidance and hands-on assistance with document drafting and formatting
Monitor and report training compliance metrics to the team and management
Track periodic review schedules and ensure timely completion
Identify trends and areas for improvement in training effectiveness
Assist in planning and execution of internal audits
Support external audits and inspections by providing documentation and system access
Maintain audit trail and metrics within the QMS
Stay current with international GxP regulations and guidance (FDA, EMA, ICH, etc.)
Interpret regulatory changes and assess impact on QA systems and processes
Lead or support CSV activities for QA-related systems (authorship and/or review of CSV documents)
Ensure validation documentation is complete, accurate, and audit ready
Ensures that project tasks are completed with acceptable quality
Attends team meetings and represents departmental needs for assigned projects
Ensures compliance with GxP regulations and guidance (FDA, EMA, ICH, etc.)
May assist in developing policies and procedures (SOPs)
Additional tasks and projects as assigned
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or related field
Minimum 7 years of experience in QA within the biotech or pharmaceutical industry
Proven experience managing electronic QMS platforms, preferably Veeva
Strong understanding of GxP regulations and CSV principles
Excellent organizational, communication, and interpersonal skills
Ability to work independently in a hybrid team environment
Excellent communication and collaboration skills with a team-oriented approach
Ability to thrive in a small company environment: fast-paced, hands-on, collaborative, and adaptable
Self-motivated with a commitment to high quality, on-time deliverables
Demonstrated ability to identify and resolve issues and effectively manage timelines
Demonstrated attention to detail and outstanding organization skills
Familiarity with remote collaboration tools and virtual team dynamics
Knowledge of data analytics tools for tracking QA metrics
Company
Avalo Therapeutics
Avalo Therapeutics is a clinical-stage biopharmaceutical company.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$231.5M2024-11-12Post Ipo Equity· $69.4M
2024-03-27Post Ipo Equity· $115.6M
2023-02-02Post Ipo Equity· $15M
Leadership Team
Garry Neil
Board Member Avalo Therapeutics
Mittie Doyle
Chief Medical Officer
Recent News
2025-11-07
Avalo Therapeutics
2025-11-03
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