Sr. Manager, Quality Assurance

Avalo Therapeutics•Chesterbrook, PA

3d•Hybrid

About The Position

At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process. We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization. Position Summary: We are seeking a highly motivated and detail-oriented Senior Manager, Quality Assurance (QA) to lead and manage our electronic Quality Management System (eQMS). This role is critical to ensuring compliance with internal procedures and global regulatory requirements. The ideal candidate will have demonstrated experience in eQMS administration, document control, training metrics, and computer system validation (CSV), and will thrive in a fast-paced, hybrid biotech environment.

Requirements

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.

Nice To Haves

Experience in a small or startup biotech environment.
Familiarity with remote collaboration tools and virtual team dynamics.
Knowledge of data analytics tools for tracking QA metrics.

Responsibilities

Serve as the system owner and 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.