Manager Quality Systems - EDMS, Patient Safety and Change Control (On Site)

Purpose and Scope

This position is responsible for providing oversight and continuously improving the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, 21 CFR Parts 210/211, and EU MDR. This role includes ownership of key processes such as document control, customer complaints, and change control, ensuring that these areas meet regulatory requirements and support the organization's commitment to quality.

Essential Duties & Responsibilities

 General:

• Participate on cross-functional teams, representing Quality Systems, to drive shared understanding of quality requirements and continuous improvement.
• Drive QMS effectiveness using data and metrics across CAPA, document/records management, training, change control, nonconformance/deviations, and management review.
• Maintain current and acquire new knowledge of regulatory compliance and industry practices through reviews of publications, conferences, and publicly available information to properly adjust compliance activities and approaches.
• Integrate Tolmar’s core values into team goals and decision-making.
• Develop and implement processes, procedures, forms, work instructions, and tools to support compliance systems.
• Support the Director Quality Systems & Compliance by coordinating projects, solving problems, and designing process improvement solutions.
• Participate in regulatory, third-party, and customer audits/inspections and support timely corrective action responses.
• Represent the Tolmar Quality Systems & Compliance management team and reflect Tolmar Values as a role model to employees, suppliers, and customers.
• Perform other related duties as assigned.

 Electronic Document Management System (EDMS) and Document Control Oversight:

• Lead the document control team; set standards, coach staff, and ensure documentation compliance.
  • Own and optimize EDMS administration (e.g., Veeva) for document storage, routing, and approvals.
  • Maintain document control procedures aligned to regulatory requirements (US and rest of world).
  • Lifecycle Management: Manage document creation, review/approval, revision control, distribution, archiving, and destruction (e.g., SOPs, batch records, quality records).
    • Manage batch records/master batch records and lot number issuance.
  • Data Integrity: Maintain current, accurate, accessible quality records in accordance with ALCOA+.
  • Regulatory Compliance & Quality:
    • Ensure documents meet cGMP and ICH requirements.
    • Provide documentation support and responses for internal audits, partner audits, and health authority inspections.

Customer Complaint Handling:

• Complaint Program Ownership: Manage the end-to-end complaint handling process, including intake, investigation, regulatory reporting, and closure.
• Trending & Escalation: Analyze complaint data to identify trends, escalating serious issues to senior management and initiating Corrective and Preventive Actions (CAPA) when necessary.

• Customer Communication: Liaise with customer technical support to facilitate investigations and responses.

 Change Control and Management:

• Establish change management metrics and reporting to drive transparency, accountability, and on-time closure across the change lifecycle.
• Change Control Administration:
  • Oversee review, approval, and implementation of changes impacting products, processes, or systems.
• System Oversight: 
  • Manage the change control process, ensuring changes are tracked, documented, and approved within the quality management system.
  • Track change control KPIs and report results to senior leadership.
  • Ensure change control activities comply with regulations and internal procedures.
  • Audit the change control process to confirm compliance and identify improvements.
• Impact Assessment & Risk Management:
  • Perform risk assessments (ISO 14971) for proposed changes to protect compliance and product quality.
  • Lead cross-functional risk assessments of changes (e.g., FMEA) to evaluate impact on product quality and safety.
• Change Control Board (CCB): Facilitate CCB review and disposition of change requests (approve/reject/modify).
• Implementation & Closure: Ensure required actions (e.g., SOP