DescriptionWe are seeking a
Senior Manager, R&D Quality - Document Control & Training to lead and continuously improve critical GxP quality system processes supporting our R&D organization. This role is responsible for document lifecycle management, training governance, inspection readiness support, process standardization, metrics/reporting, and cross-functional quality systems partnership.
The ideal candidate brings strong experience in
controlled document management,
training administration/governance, and
GxP quality systems within biotech, pharma, or life sciences. This is a highly collaborative role requiring partnership across Quality, Clinical, Nonclinical, Regulatory, Safety/Pharmacovigilance, and other stakeholders to ensure compliant, scalable, and efficient processes.
What you'll do- Lead controlled document and training processes in a GxP-regulated environment
- Drive process improvements across document control, training, and quality systems workflows
- Support audit and inspection readiness activities
- Monitor and trend quality system metrics and identify opportunities for improvement
- Partner cross-functionally to improve compliance, standardization, and operational effectiveness
- Provide subject matter expertise on document control and training systems/processes
What we're looking for- Experience in Quality, Quality Systems, Compliance, or related functions in biotech/pharma/life sciences
- Strong experience with document control and training processes in a regulated environment
- Knowledge of GxP requirements relevant to R&D/development organizations
- Ability to work cross-functionally and influence in a matrixed environment
- Experience supporting inspections, audits, and continuous improvement initiatives
Strongly preferred- Direct experience with Veeva Vault
- Direct experience with ComplianceWire
- Experience in R&D, clinical, nonclinical, or development-phase quality environments
- Experience with metrics, reporting, and process harmonization
Keywords: Quality Systems, Document Control, Training, GxP, R&D Quality, Veeva Vault, ComplianceWire, Inspection Readiness, Audit Support, SOPs, Controlled Documents, LMS, Biotech, Pharmaceutical, Quality Management Systems
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
