Head of Quality Assurance.
This mandate is run by SYMPHONI HR, a Mumbai-based executive search firm, est. 2003. Applications are email-verified and reach the search team running the role — confidentially, always.
About the organisation.
Our client is a leading global chemical company specializing in the development and manufacturing of infection prevention products. They are committed to maintaining the highest standards of quality, safety, and efficacy in their offerings. With a focus on innovation and compliance, they serve a broad market, ensuring robust quality management across all operations.
About the role.
This pivotal role involves providing strategic and functional leadership for the entire Quality function, encompassing Quality Assurance, Quality Control, and Microbiology. The Head of Quality Assurance will be accountable for establishing and maintaining robust Quality Management Systems, ensuring product quality, and driving regulatory compliance. This position is critical for ensuring that all products consistently meet applicable global quality, safety, efficacy, and regulatory standards.
What you will do.
- Define and lead the organization’s overall Quality strategy covering QA, QC, and Microbiology, establishing policies and governance frameworks.
- Establish, implement, maintain, and continuously improve the organization’s Quality Management System, ensuring effective governance of SOPs, deviations, CAPA, and change controls.
- Provide overall leadership and governance of chemical, analytical, and physical Quality Control laboratories, ensuring appropriate testing and release of materials and products.
- Provide functional leadership for the Microbiology laboratory and microbiological quality systems, overseeing environmental monitoring and contamination control strategies.
- Ensure that products are manufactured, tested, reviewed, and released in accordance with approved specifications and applicable regulatory requirements.
- Ensure organizational readiness for domestic and international regulatory inspections and customer audits, leading the Quality organization during these events.
- Provide Quality oversight for facility, equipment, utility, process, cleaning, analytical method, and computerized system validation.
- Ensure timely investigation of customer complaints and product quality concerns, overseeing trend analysis and leading product recall processes when required.
- Establish supplier qualification, evaluation, audit, and monitoring systems, ensuring Quality oversight of critical service providers.
- Drive a proactive Quality culture focused on prevention, continuous improvement, and reduction in quality-related losses.
What you bring.
- Bachelor’s / Master’s degree in Pharmacy, Chemistry, Microbiology, Biotechnology, Life Sciences, or a related discipline.
- 15+ years of progressive Quality experience within pharmaceuticals, medical devices, infection prevention, or other highly regulated industries.
- Significant leadership experience with responsibility for QA, QC, and/or Microbiology functions, preferably with overall Quality leadership exposure.
- Strong understanding of global GMP, Quality Management Systems, medical device quality requirements, and international regulatory expectations.
- Demonstrated experience in regulatory inspections and customer audits, including exposure to EU, USFDA, and CE/MDR requirements.
- Strong expertise in QMS, CAPA, Change Control, OOS/OOT, Quality Risk Management, Validation, Data Integrity, and Audit Management.
- Strong understanding of analytical Quality Control and microbiological Quality systems.
- Experience leading multidisciplinary Quality teams in a manufacturing environment.
- Strong analytical, investigation, decision-making, and problem-solving capability.
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