Quality Assurance Lead-Regulatory Affairs

SQR:

Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!

Your role:

As Manager, Quality Management, you will build and lead the hosted Quality Management team based at our Global Business Services (GBS) campus in Bangalore. You will be accountable for quality deliverables across Fresenius Medical Care’s global product portfolio as a full member of the global SQR team.

• Build, lead and develop a high-performing Quality Management team – recruitment, onboarding, coaching, performance management and succession planning, in partnership with global SQR leadership and GBS enabling functions
• Hold end-to-end accountability for quality deliverables as an integral part of the global and regional Quality teams: controlled document management, supplier quality, quality data and KPI reporting, learning and training compliance, and support for clinical evaluation and post-market documentation
• Own document control processes – authoring, review, approval and maintenance of SOPs, work instructions and controlled records – ensuring compliance with ISO 13485, 21 CFR Parts 820/QMSR and applicable regional QMS requirements
• Support supplier quality management: supplier qualification and performance monitoring, quality agreements, non-conformance handling and supplier CAPA follow-up
• Support execution of CAPA, non-conformance and complaint-handling activities, assessing quality impact and driving root-cause investigations together with R&D, Regulatory Affairs and Operations
• Own quality data governance and data quality in the QMS and related systems, ensuring completeness, accuracy and audit readiness of quality records, in line with global SQR data standards and governance
• Grow the quality management scope executed from Bangalore in line with the global SQR operating model – capability mapping, knowledge transfer, training and qualification of staff, and steady-state execution to global standards
• Define and track quality, timeliness and compliance metrics for the team’s deliverables, and drive standardisation, harmonisation, automation and continuous improvement of global quality processes
• Act as a trusted functional partner and escalation point for global Quality leadership, Regulatory Affairs, R&D, Supply Chain and Commercial teams, and represent the Bangalore team in global quality forums
• Support internal and external audits and inspections (Notified Body, MDSAP, FDA) and ensure inspection-ready documentation at all times
• Represent Quality Management within the SQR leadership team in India and work with GBS site leadership and enabling functions on workforce planning, hiring, engagement, retention and site-level matters, while functional ownership of the work remains with global SQR

Your Profile:

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical or Biotechnology Engineering, or a related field; advanced degree preferred
• 12–16 years of Quality Management experience in medical devices, IVD, combination products or pharmaceuticals, including at least 5 years leading and developing teams
• Hands-on experience with QMS document control, supplier quality management, CAPA and non-conformance handling, and internal audits in a regulated manufacturing environment
• Working knowledge of ISO 13485, ISO 9001, ISO 14971, 21 CFR Parts 820/QMSR and 803, MDSAP and applicable EU MDR/IVDR quality requirements
• Experience working in a global capability centre or an offshore team that is functionally directed by a global organisation, including building capability and scaling scope, is strongly preferred
• Proficiency with QMS and document management systems (e.g. Veeva Vault QMS, TrackWise, SAP) and reporting tools such as Power BI
• Demonstrated ability to set performance standards, track quality and timeliness metrics and drive process improvement; Lean or Six Sigma exposure is an advantage
• ASQ CQM/OE, CQA or equivalent quality certification is desirable
• Excellent written and verbal communication in English, with proven stakeholder management in a global matrix across multiple time zones
• Strong people leadership, talent development and change management skills, with high integrity and a patient-first mindset

Our offer:

There is a lot you can discover at Fresenius Medical Care. No matter which field you are an expert in and how much experience you have, all dedicated to your professional journey.

• Whether in front of or behind the scenes - you are helping to make ever better medicine available to people around the world
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
• Modern office location with hybrid work set up. We are located in Hebbal, Bangalore.
• You will be entitled to healthcare, insurance and transportation benefits