Quality Assurance Deviation Manager

Ultragenyx Pharmaceutical•Woburn, MA

13h•Onsite

About The Position

ultrafocused – Work together to fearlessly uncover new possibilities The QA Deviation Manager is responsible for providing quality oversight of GMP deviations within a QC Laboratory supporting gene therapy programs. This role partners closely with deviation owners to ensure timely, compliant, and thorough completion of investigations and associated quality records. The position also supports change controls, CAPAs, and regulatory inspections as part of the site Quality Management System (QMS). This is an onsite, hands-on QA role requiring strong GMP knowledge, investigative expertise, and the ability to influence in a fast paced, highly regulated environment. Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Requirements

Bachelor’s degree in a scientific discipline.
Minimum 7 years of experience in GMP Quality Assurance with direct responsibility for deviations/investigations.
Demonstrated proficiency in root cause analysis tools (e.g., Fishbone, 5 Whys, Ishikawa).
Strong analytical and communication skills, including the ability to coach deviation owners.
Experience supporting GMP QC laboratories; understanding of analytical method execution and laboratory workflows.
Strong understanding of FDA, EMA, and ICH regulations applicable to biologics or gene therapy.

Responsibilities

Provide QA oversight and approval of GMP deviations generated within the QC Laboratory (including associated support groups including Lab Operations and Facilities).
Guide deviation owners through investigation phases to ensure high-quality, accurate, and timely records
Ensure investigations identify true root causes using established methodologies (5 Whys, Fishbone, etc.).
Assess and confirm appropriate CAPAs linked to deviations, ensuring effectiveness and closure.
Maintain compliance with internal procedures, regulatory expectations, and QMS requirements.
Support review and approval of change controls associated with QC lab as needed.
Participate in trending and data analysis activities to identify systemic issues and opportunities for improvement.
Contribute to continuous improvement initiatives to enhance investigation quality and right first-time metrics.
Provide QA support to other Analytical QA activities as needed.
Support regulatory inspections and internal/external audits as an SME for deviations and lab investigations.