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.
Essential Duties and Responsibilities:
Veeva QMS Administration:
- 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.
Document Control & Compliance:
- 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.
Training & Metrics:
- 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.
Audit & Inspection Readiness:
- 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.
Regulatory Intelligence:
- Stay current with international GxP regulations and guidance (FDA, EMA, ICH, etc.).
- Interpret regulatory changes and assess impact on QA systems and processes.
Computer System Validation (CSV):
- 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.
Education & Experience:
- 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.
Additional Skills, Knowledge, and/or Attributes:
- 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.
Location: This position is based in Chesterbrook, PA and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
About Avalo Therapeutics
Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, AVTX-009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com.
ATTENTION: External Agencies and Placement Firms
A member of the Avalo Human Resources Department will contact an agency directly if an open position is eligible to be sourced from an outside recruiting service. Avalo does not accept unsolicited resumes from employment agencies for any employment opportunity. All agencies/recruiters must have a written agreement/SOW in place with Avalo and prior to submitting any resume or CV.
All resumes must be submitted through the appropriate process. Any resumes submitted without an agreement and/or any resumes sent unsolicited through e-mail accounts of Avalo employees will be considered outside of the appropriate process, do not imply or create any obligation on our part, do not impart any restrictions on Avalo with respect to the hiring of any persons whose resumes are so submitted and are not eligible for placement fees.