QMS Manager

Job Title: eQMS Leader (Global QMS / MasterControl)

Location: Remote Role with Preference of Boston-Based Candidates

About Hobson Associates’ Client:

Our client is a global regenerative medicine company focused on developing and commercializing innovative wound healing and tissue repair technologies. The company's proprietary self-assembling peptide platform is designed to support the body's natural healing process and is utilized across multiple surgical, endoscopic, and wound care applications.

This organization has secured regulatory approvals across several global markets and continues to expand its commercial footprint through the advancement of its regenerative medicine platform. The organization is committed to improving patient outcomes by developing next-generation technologies that address unmet clinical needs in tissue healing and regeneration.

Position Summary:

The eQMS Leader is responsible for the design, implementation, and continuous improvement of the global electronic Quality Management System (eQMS) in alignment with regulatory requirements (ISO 13485, MDR, FDA QMSR).

This role ensures that the eQMS effectively supports the One QMS strategy, enables global process harmonization, and maintains data integrity and compliance across all regions (EU, US, JP, (AU)).

Key Responsibilities:

• eQMS Implementation (Primary Responsibility):
• Lead the end-to-end implementation of the eQMS (e.g., MasterControl)
• Define system architecture aligned with Global QMS processes
• Configure workflows (CAPA, Change, Complaint, Document Control, Training)
• Coordinate system deployment across regions (EU, US, JP, AU)
• Process Integration:
• Translate Global SOPs into system workflows
• Ensure end-to-end process connectivity:
• Complaint → CAPA → Change → Training
• Maintain traceability and audit trails within the system
• Validation and Compliance (CSV / CSA):
• Define and execute system validation strategy (CSA-based approach)
• Ensure compliance with:
• ISO 13485
• FDA 21 CFR Part 11
• MDR data integrity expectations
• Maintain validation documentation (URS, risk assessment, test scripts)
• System Governance:
• Establish user roles, permissions, and access controls
• Manage system configuration changes (change control)
• Ensure data integrity and security
• Training and Adoption:
• Develop and deliver user training programs
• Support Local MR and QA teams in system adoption
• Monitor user compliance and training completion
• Continuous Improvement:
• Monitor system performance and user feedback
• Identify optimization opportunities
• Support KPI reporting and analytics
• Audit and Inspection Support:
• Serve as SME during audits (BSI, FDA, internal)
• Demonstrate system functionality and traceability
• Support audit responses related to eQMS

Interfaces and Collaboration:

• Global Management Representative (alignment & governance)
• Local Management Representatives (EU, US, JP, (AU))
• QA/RA teams (process implementation)
• IT / vendors (system support)
• Notified Body / Regulatory authorities (during audits)

Required Qualifications:

• Bachelor’s degree or higher in Life Sciences, Engineering, or related field
• Past experiences in Quality, QMS Management, Regulatory in medical device industry
• Hands-on experience with eQMS systems (MasterControl preferred)
• Experience in global QMS implementation and transformation
• Experience with audits (ISO 13485, FDA, MDR)

Technical Skills:

• Strong understanding of:
• CAPA, Change Control, Complaint handling
• Document control and training systems
• Knowledge of:
• Computer System Validation (CSV / CSA)
• Data integrity principles
• Ability to design workflows and system configurations

Soft Skills:

• Strong project management skills
• Cross-functional leadership
• Ability to translate business processes into system solutions
• Communication across global teams

Authority and Accountability:

• Responsible for eQMS design and implementation
• Authority to define system workflows and standards
• Accountable for system compliance and audit readiness

Success Metrics and KPIs:

• eQMS implementation timeline adherence
• User adoption rate (%)
• Training completion rate
• CAPA / Change / Complaint cycle time improvement
• Audit findings related to eQMS (target: 0 major)

Reporting Structure in Organization:

• Reports to: Global QMS Manager or Global QARA Head
• Works closely with:
• Global QARA team
• Local QARA teams