Quality Systems Team Lead

Role Summary
The Team lead will be responsible for a multidisciplinary team handling Process Management, Audit Management, CAPA coordination, Training Management, Process Software, QMS Release Support , Information Security, Complaint Management, and Digitalization projects. Specifically, this role will require alignment with the various stakeholders responsible for these topics and shall oversee the activities to ensure effective execution. The Team Lead ensures quality system initiatives directly support organizational strategy, regulatory compliance, and business objectives.
The key responsibility of this role is to build and lead a high-performing team; Manage resourcing, xBL relationships, and cross-functional priorities. Lead and manage the team that deals with the below core responsibilities.
Core Responsibilities of Team:
QMS Release Support

• Support the QMS release cycles by ensuring the release availability of process deliverables as per the plan
• Establish clear communication channels to ensure all stakeholders are informed and engaged throughout the QMS release lifecycle
  

CAPA Coordination

• Enhance the Quality & timeliness of CAPA CRs ensuring they are comprehensive, actionable, and address root causes effectively.
• Contribute to the CAPA process improvements
• Perform the Operative CAPA Co-ordination activities (Conduct of CCBs)
  

Information security

• Support in migrating to the latest version of the relevant standards
• Assess & implement relevant regulations for D&A like for e.g., TX RAM, BSI C5 for cloud products, NIS 2
• Address the gaps in existing Information security management system ( E.g. business continuity management)
  

Training Management

• Ensure execution of the operational activities within the training management area (L4U administration, SHARP ticketing system, Training reporting etc. ) are conducted seamlessly.
• Monitor and ensure on?time completion of all mandatory training. Maintain training?compliance records and report status regularly
  

Digitalization & Continuous Improvement

• Support the team by for issue resolutions to maintain momentum in ongoing, cross?organizational projects that digitize and automate processes.
  

Complaint Management

• Oversee the team that handles complaints and support smooth operation of the activities assigned.
  

Required Qualifications

• Bachelors degree in Engineering, Life Sciences, Quality, or related field; Masters preferred.
• 812+ years in Software quality processes (SaMD), CAPA, Audit and related topics, with 35+ years in people management.
• Strong working knowledge of relevant standards/regulations (e.g., ISO 9001/13485, ISO 14971, MDR; FDA 21 CFR 820 if applicable).
• Ability to influence and coach teams and employees, excellent communication and documentation skills.
• Lead Auditor Certified (ISO 9001/13485)
  

Skills & Competencies

• QMS mastery; regulatory literacy; risk-based thinking.
• Audit planning, interviewing, evidence evaluation; RCA (5-Why, Fishbone), FMEA.
• Data-driven decision-making;
• Tool administration, workflow configuration, change management.
• People leadership, coaching, stakeholder management, conflict resolution.
• Clear, structured writing; SOPs, work instructions, and executive summaries.