Quality Assurance Manager – Deviation Management

Reporting to the Associate Director, Quality Assurance – Batch Review and Disposition, the Quality Assurance Manager is the site owner for the oversight, progression, and on-time closure of batch-impacting deviations and other batch-gating quality system records managed in Veeva QMS. This is an individual contributor position with no direct reports; the Manager leads through influence, partnership, and clear accountability across Formulation/Filling, Inspection/Packaging, MS&T, Quality Assurance, Quality Control, Engineering/Facilities, Validation, and Supply Chain.

The Manager provides end-to-end oversight of the deviation lifecycle—from initiation and triage to deviation writer assignment, investigation, review and approvals, through closure—ensuring each record is completed on time and to quality standard and in accordance to procedure. The Manager coordinates and drives cross-functional deviation teams, sequences work against batch disposition due dates, removes barriers, and escalates promptly when timelines or investigation quality are at risk.

This position is also a change agent. The Manager is expected to identify friction in the current deviation process, design and implement better ways of working within Veeva QMS, and raise the overall speed and quality of investigations so that batches are dispositioned on time for our clients and their patients. The Manager owns deviation and turnaround-time metrics and KPIs tied to batch disposition performance, and presents that data to site leadership, clients, and inspectors with clarity and command of the underlying records.

The Quality Assurance Manager will demonstrate excellent written and oral communication skills, strong technical writing and investigation review capability, and the ability to hold peers and senior stakeholders accountable to commitments in a constructive, collaborative manner. The Manager will thrive in a team environment while also working autonomously with sound scientific judgment and risk-based decision making.

Scope and Authority:
The Quality Assurance Manager owns delivery, prioritization, and escalation of batch-impacting quality event closure and supports product impact and disposition assessments.

• Own oversight of batch-impacting deviations in Veeva QMS from initiation through closure, maintaining real-time visibility of record status, ownership, aging, and due dates against committed batch disposition dates.
• Drive cross-functional deviation teams to on-time completion across Formulation/Filling, Inspection/Packaging, MS&T, Quality Assurance, Quality Control, Engineering/Facilities, Validation, and Supply Chain, without direct reporting authority, by setting clear expectations, sequencing tasks, and following through to closure.
• Manage the full deviation lifecycle cadence – initiation, triage, writer assignment, investigation and data gathering, product impact assessment, CAPA identification, review, approvals, and closure – ensuring each stage advances within procedural time frames.
• Track all batch-gating QMS records (deviations, related change controls, CAPAs, and other quality events required for disposition) tied to open lots, and maintain a prioritized, disposition-driven work queue shared with Manufacturing, Quality, and Project Management.
• Chair recurring deviation and batch-gating review meetings to align on priorities, confirm commitment dates, resolve barriers, and drive decisions that keep records moving toward closure.
• Escalate promptly and objectively when investigation timelines, data availability, resourcing, or record quality place a batch disposition commitment at risk, providing options and recommended paths forward to the Associate Director and site leadership.
• Review deviation content for technical and compliance quality for problem statement clarity, event timeline, evidence gathered, root cause methodology and conclusion, product quality and SISPQ impact rationale, batch and lot extent-of-condition, and adequacy of corrective and preventive actions.
• Coach deviation writers and investigation owners on investigation methodology, GMP-appropriate technical writing,…