Sr. Mgr., Quality Management Systems

Reporting to the Associate Director, Quality Management Systems, the Senior Manager, Quality Management Systems will lead the administration, governance, and continuous improvement of the company’s Quality Risk Management (QRM) program and serve as a trained backup for Document Control and the GxP Training Program. This role partners closely with the Associate Director and cross-functional stakeholders to embed risk-based decision-making across GxP operations while ensuring assigned QMS processes are compliant, inspection-ready, effective, and scalable in alignment with global regulatory requirements and organizational objectives.

Quality Risk Management Program Leadership

• →Lead the development, deployment, and continuous improvement of the QRM program, including procedures, templates, tools, and risk registers.
• →Facilitate cross-functional risk assessments using appropriate methodologies, including fit-for-purpose tools (e.g. risk ranking and filtering, hazard analysis, FMEA).
• →Ensure risk assessments define risk owners, mitigation actions, due dates, residual-risk decisions, and review requirements; monitor mitigation activities and escalate significant or overdue risks.
• →Integrate QRM principles into applicable processes and communicate QRM metrics and trends through Management Review and other governance forums.
• →Provide QRM guidance and training, maintain inspection-ready documentation, and support audits and regulatory inspections.

QMS Operations & Process Support

• →Serve as a trained backup for Document Control and GxP Training activities, including controlled-document workflows, training assignments, compliance monitoring, and maintenance of inspection-ready records.
• →Oversee assigned QMS workflows, author or revise quality procedures, monitor KPIs, and implement improvements that promote compliance, efficiency, and scalability.

Inspection Readiness & Cross Functional Collaboration

• →Maintain audit-ready QMS documentation and records and support audit and inspection preparation, responses, and finding closure.
• →Collaborate across GMP, Clinical, CMC, Regulatory, Supply Chain, and other functions to promote quality culture and provide practical, risk-based guidance.

Systems & Digital Quality Support

• →Support eQMS administration and optimization
• →Partner with IT to resolve issues and implement improvements

• →Provide Quality oversight or support for risk-based validation and lifecycle management of GxP computerized systems, as assigned.

• Bachelor's degree in scientific or technical discipline, or equivalent relevant experience.
• Minimum of 7 years of progressive Quality Assurance or related experience in pharmaceutical or biotechnology industry.
• Experience building, deploying and continuous improvement of a QRM program, facilitating cross-functional risk assessments, and applying fit for purpose methodologies (e.g. risk ranking and filtering, hazard analysis, FMEA, etc.) in a GxP-regulated environment.
• Working knowledge of applicable GxP regulations, and global regulatory expectations.
• Ability to lead cross-functional initiatives, and effectively communicate clear, risk-based quality guidance.
• Ability to manage multiple priorities and make sound decisions when working with incomplete information or changing business needs.
• Hands-on experience with Veeva Vault Quality applications, including QualityDocs, Training, and QMS, and supporting Document Control and GxP Training processes.
• Experience with Computer System Validation, including risk-based validation and lifecycle approaches for GxP computerized systems.
• Experience with APQR/PQR activities, QRM metrics, or Management Review reporting.