Senior Manager, Global Quality Management System (Global R&D & PV QA) (m/w/d)

Global QMS Process Ownership and Implementation:

• Serve as global process owner and SME for assigned QMS domains (e.g., GSOP governance, document management, training framework, metrics)


• Lead end-to-end SOP oversight, ensuring procedures are globally harmonised, cross-referenced and consistent, and compliant with GCP/GLP/GVP and international regulatory standards

Global SOP Committee (GSOPC) and Governance Leadership:

• Provide strategic oversight and operational leadership for GSOP Committee (GSOPC) activities


• Ensure efficient SOP lifecycle management, timely approvals and publication, and cross-functional governance alignment


• Lead global collaboration across regions and functions to ensure procedural consistency

Training Strategy and Capability Building:

• Act as global training lead, responsible for defining the QMS training strategy, driving inspection readiness training programmes, and ensuring alignment with regulatory expectations


• Develop and deliver GCP/GLP/GVP and inspection readiness training in collaboration with Functional QA


• Lead change management and communication strategies for procedural updates

Quality Metrics, Data Analytics, and Continuous Improvement:

• Lead development and oversight of global QMS metrics and dashboards, ensuring alignment with regulatory expectations


• Analyse audit findings, inspection trends, and quality metrics to identify systemic risks and improvement opportunities


• Drive continuous improvement initiatives at global level

Regulatory Inspection, Audit, and Compliance Leadership:

• Serve as primary QMS liaison for regulatory inspections and audits (FDA, EMA, PMDA, NMPA, etc.)


• Lead inspection readiness strategy, preparation activities and documentation alignment, and inspection participation and response coordination


• Provide expert input into CAPA development and effectiveness verification, ensuring sustainability of corrective actions

Regulatory Intelligence and Strategic Integration:

• Partner with Regulatory Affairs to monitor global regulatory developments (GCP/GLP/GVP) and assess impact on QMS processes


• Lead integration of new regulations into SOPs, training, and QMS frameworks

Education:

• Bachelor's degree in Life Sciences, Pharmacy, IT, or a related field required


• Master's degree or higher preferred

Experience:

• 8–12 years of relevant GxP QA experience, including global QMS implementation and governance, SOP oversight and harmonisation, and inspection and audit leadership


• Demonstrated experience in regulatory inspections (FDA/EMA/PMDA/NMPA), CAPA management and effectiveness, and cross-functional global projects


• Strong knowledge of ICH, GCP/GLP/GVP frameworks, and global regulatory requirements

Competencies:

• Strong subject matter expertise in global QMS and regulatory compliance


• Strategic thinking with data-driven decision-making capability


• Proven ability to lead in a global matrix environment and influence stakeholders


• Excellent communication skills across functions and regions


• Ability to drive continuous improvement and organisational alignment