General Manager of QA

Business / Operations

• Provide strategic leadership for Quality Assurance across all plant and central functions.
  

• Develop and implement quality strategies and long -term improvement plans that align with business objectives and regulatory requirements.
  

• Ensure effective implementation, maintenance, and enhancement of QMS frameworks (ISO 13485, FDA QSR, MDR, MDSAP) across the organisation.
  

• Monitor QA performance across plants and central teams using KPIs, benchmarks, and structured performance reviews.
  

• Drive harmonisation of QA systems, including CAPA, change control, complaints handling, audits, laboratory testing, calibration, and validation processes.
  

• Ensure corrective and preventive actions are executed consistently and sustained throughout all plants.
  

• Assess quality risks and enforce mitigation plans across operational areas.
  

• Lead preparation and readiness for regulatory inspections and major customer audits.
  

• Collaborate closely with leadership to integrate quality objectives into business strategy.
  

• Lead escalation management for critical quality issues, regulatory findings, and supplier rejections, ensuring effective resolution.
  

• Facilitate cross -functional root cause analysis and implementation of long -term preventive actions for systemic issues.
  

• Manage QA budgets, resources, and headcount to support optimal operational execution.
  

• Oversee quality aspects in NPI/NPD to ensure compliance with regulatory and system requirements.
  

• Lead performance evaluations, development initiatives, and succession planning for QA teams.
  

• Perform additional duties as required.
  

People / Stakeholder Management

• Lead, mentor, and develop QA leaders to ensure capability, alignment, and strong performance.
  

• Promote knowledge sharing and cultivate a proactive, quality -driven culture.
  

• Drive talent development and succession planning across all levels of the QA function.
  

• Build strong internal partnerships with Operations, R&D, Sales, Procurement, and Supply Chain teams.
  

• Serve as the primary liaison with regulators, customers, and industry bodies on quality -related matters.
  

• Champion change management and continuous improvement initiatives.
  

• Represent the QA function in leadership forums and strategic discussions.
  

• Oversee performance appraisals, career development, and succession planning for direct reports and broader QA teams.
  

Requirements

Education

• Bachelor’s or Master’s Degree in Engineering, Science, or a related field.
  

Work Experience

• Minimum of 15 years of experience in manufacturing, including at least 8 years in managerial roles; experience in medical devices or other regulated industries is preferred.
  

• Demonstrated leadership in QMS, regulatory compliance, and customer -facing quality functions.
  

• Proven experience overseeing multi -site QA operations and leading regulatory inspections.
  

Technical & Professional Knowledge

• Strong understanding of GMP and manufacturing technologies.
  

• In -depth knowledge of QMS standards (FDA QSR 21 CFR 820, ISO 13485, ISO 14971, ISO 2859, ISO 9001).
  

• Proficient in CAPA, root cause analysis, and quality auditing.
  

• Familiar with Lean methodologies and operational excellence practices.
  

• Strategic thinker with strong analytical, problem -solving, and project management capabilities.
  

• Excellent communication, negotiation, leadership, and people development skills.
  

• Skilled in complaint analysis and driving systemic quality improvements.
  

Certification / License

• ISO 13485 Lead Auditor certification or equivalent is preferred.