About this role
Responsibilities
Direct and continuously improve the eQMS, quality systems, and document control functions of Quality Assurance, including the following:
eQMS Administration & Optimization (MasterControl)
- Serve as system owner for MasterControl, with full accountability for configuration, performance, compliance, and continuous improvement.
- Own and execute system strategy, including optimization of quality event workflows, vaults, lifecycles, InfoCards, and electronic forms to enhance efficiency and user experience.
- Ensure robust governance of electronic data, including audit trail oversight, access controls, and data integrity standards.
- Oversee user lifecycle management (onboarding, offboarding, role changes), license allocation, and access governance across GxP systems (eQMS, IMS, asset management).
- Act as the primary escalation point for system-related issues and interface with MasterControl technical support.
- Establish advanced reporting and analytics capabilities to enable data-driven decision-making across the organization.
Quality Systems & Change Control
- Own and continuously improve the site-wide change control program, ensuring risk-based, compliant, and timely execution.
- Facilitate Change Review Board (CRB) meetings and drive cross-functional alignment.
- Mentor and coach stakeholders in the development of high-quality change controls, providing guidance on proposed changes, impact assessments, and regulatory considerations to ensure changes are appropriately justified, compliant with GMP expectations, and aligned with QMS requirements.
- Establish and monitor quality system KPIs and performance metrics to ensure compliance with GMP and internal standards.
- Develop robust data collection and trending methodologies to support routine and ad hoc reporting.
- Analyze trends and provide actionable recommendations to improve quality system effectiveness, inspection readiness, and operational performance.
- Lead or support cross-functional quality improvement initiatives to enhance QMS maturity and efficiency.
- Author, review, and maintain SOPs, work instructions, and other controlled documents related to eQMS processes, ensuring clarity, compliance, and consistency.
Supervisory Responsibilities
- Directly supervise the Document Control Specialist, including workload assignment, performance management, training, and professional development.
- Serve as a point of escalation and mentor for document control and quality systems staff.
- Provide support during audits and regulatory inspections by serving as logistics room lead. Under time-sensitive conditions, manage and provide documents requested by the auditor/inspector and coordinate with the appropriate SMEs to answer questions posed by the auditor/inspector.
Qualifications
- Bachelor’s degree in a science, business management, or information management related discipline.
- 5+ years of progressive experience in quality systems management or in a highly regulated industry.
- Experience developing and configuring workflows, forms, and document routing structures within MasterControl Software or similar eQMS platforms.
- Experience leading eQMS validation efforts or system-wide configuration decisions within MasterControl or similar platforms.
- Knowledge of data integrity expectations, GxP compliance, software development lifecycle, and good documentation practices.
- Experience interacting and working with cross-functional teams.
- Knowledge of and ability to follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
- Strong technical abilities with an understanding of quality management systems.
- Strong understanding of governing regulations and standards for computerized quality systems and data integrity.
- Deep knowledge of cGMP, FDA, EMA, and ICH regulatory requirements.
- Strong understanding of data integrity principles (ALCOA++)
- Experience with system Validation and computerized systems compliance
- Excellent Analytical skills with the ability to translate data into actionable insights
- Strong project management and organizational skills
- Effective communication and stakeholder engagement skills
- Ability to mentor and influence cross-functional teams