Job Description:
Senior Quality Systems Coordinator
The Senior Quality Systems Coordinator (Contract) supports site integration activities by coordinating core Quality System workflows, including Change Control, Nonconformance (NC), and Corrective and Preventive Action (CAPA). This role is responsible for assessing the current state of quality system processes, driving execution through structured coordination, and providing clear visibility into system performance and risks. Additionally, this role will support document control activities and act as a SharePoint administrator to ensure accurate and compliant document management. This role requires close collaboration with teams in Germany and flexibility to align with CET/CEST working hours.
Key Areas of Responsibility
Coordinate Change Control, Nonconformance, and CAPA workflows to ensure timely progression, closure, and compliance.
Monitor record status, identify bottlenecks, and proactively drive actions to meet integration timelines
Facilitate cross-functional alignment to ensure completeness, accuracy, and consistency of quality records
Ensure downstream impacts (e.g., document updates, training, implementation activities) are identified and tracked
Develop and communicate summaries, dashboards, and status updates to stakeholders and leadership
Draw conclusions on overall system health and recommend targeted actions
Schedule and lead recurring and ad hoc meetings to drive progress, remove barriers, and ensure accountability
Partner with cross-functional stakeholders to define priorities and align on next steps
Document meeting outcomes, action items, and decisions, ensuring follow-up to closure
Identify and escalate risks, delays, or compliance concerns in a timely and structured manner
Ensure critical issues are visible and appropriately managed through resolution
Manage document control activities, including document creation, review, approval, and lifecycle management
Serve as SharePoint administrator to maintain document repositories, permissions, and structure
Ensure document organization supports accessibility, traceability, and compliance requirements
Support migration and harmonization of documents as part of integration activities
Education/Work Experience
Bachelors degree in science, engineering, business, or related discipline preferred
36%2B years of experience in quality systems, regulatory, or compliance roles within a regulated industry
Knowledge/Competencies
Working knowledge of quality system processes (Change Control, CAPA, Nonconformance, Document Control)
Strong ability to assess process performance, identify gaps, and drive improvements
Demonstrated project coordination and organizational skills, with ability to manage multiple priorities
Strong communication and stakeholder engagement skills, including escalation and influence across functions
High attention to detail with a commitment to accuracy and quality
Proficient in Microsoft Office tools, including Teams, SharePoint, Excel, PowerPoint, and Word
Experience using SharePoint as a document management platform (including administration and maintenance)
Ability to create reports, dashboards, and presentations to communicate status and insights
Detail-oriented with strong organizational skills
Customer service-focused with a proactive and responsive mindset
Ability to operate independently while effectively coordinating across teams
Strong analytical and critical thinking skills
Action-oriented, with the ability to drive execution and accountability
Ability to work flexible hours to accommodate German time zones
Schedule and lead recurring and ad hoc meetings to drive progress, remove barriers, and ensure accountability
Partner with cross-functional stakeholders to define priorities and align on next steps
Document meeting outcomes, action items, and decisions, ensuring follow-up to closure
Identify and escalate risks, delays, or compliance concerns in a timely and structured manner
Ensure critical issues are visible and appropriately managed through resolution
Manage document control activities, including document creation, review, approval, and lifecycle management
Serve as SharePoint administrator to maintain document repositories, permissions, and structure
Ensure document organization supports accessibility, traceability, and compliance requirements
Support migration and harmonization of documents as part of integration activities