Role Summary:

This role is responsible for providing strategic and functional leadership for the entire Quality function encompassing Quality Assurance (QA), Quality Control (QC), and Microbiology across the organization. The role has overall accountability for establishing and maintaining robust Quality Management Systems, laboratory controls, microbiological assurance, product quality, batch release, validation, regulatory compliance, and inspection readiness to ensure that the organizations infection prevention products consistently meet applicable global quality, safety, efficacy, and regulatory standards.

Tarapur Location.

Responsibilities:

Quality Strategy & Governance:

- Define and lead the organizations overall Quality strategy covering QA, QC, and Microbiology.

- Establish quality policies, governance frameworks, systems, standards, and annual quality objectives aligned with business and regulatory requirements.

- Ensure independence and objectivity of the Quality function in decisions impacting product quality and compliance.

- Establish appropriate Quality KPIs, review mechanisms, escalation processes, and management governance.

- Act as the senior Quality representative in management reviews and strategic business discussions.

Quality Assurance & QMS Leadership:

- Establish, implement, maintain, and continuously improve the organizations Quality Management System.

- Ensure effective governance of SOPs, deviations, CAPA, change controls, OOS/OOT, risk assessments, complaints, recalls, and document control.

- Ensure manufacturing, packaging, warehousing, and distribution activities comply with approved procedures and applicable GMP requirements.

- Provide Quality oversight for batch documentation, product disposition, and release processes.

- Ensure strong data integrity and Good Documentation Practices across operations.

- Drive Quality Risk Management across products, processes, facilities, equipment, and systems.

Quality Control Leadership:

- Provide overall leadership and governance of chemical, analytical, and physical Quality Control laboratories.

- Ensure appropriate testing and release of raw materials, packaging materials, in-process samples, and finished products.

- Ensure analytical methods are scientifically sound, validated/verified, controlled, and appropriately transferred.

- Oversee laboratory investigations including OOS, OOT, atypical results, and laboratory deviations.

- Ensure calibration, qualification, and maintenance of laboratory instruments and equipment.

- Strengthen laboratory productivity, accuracy, turnaround time, and Right-First-Time performance.

Microbiology & Contamination Control:

- Provide functional leadership for the Microbiology laboratory and microbiological quality systems.

- Ensure appropriate microbiological testing of raw materials, finished products, water systems, and manufacturing environments as applicable.

- Oversee environmental monitoring and microbiological surveillance programs.

- Ensure appropriate microbial limit testing, disinfectant efficacy studies, preservative effectiveness testing, and other relevant microbiological evaluations.

- Establish contamination-control strategies appropriate to the organizations infection prevention manufacturing environment.

- Investigate microbiological excursions and ensure scientifically robust root-cause analysis and CAPA.

Product Quality & Batch Release:

- Ensure that products are manufactured, tested, reviewed, and released in accordance with approved specifications and applicable regulatory requirements.

- Establish robust product-release governance with appropriate QA, QC, and Microbiology controls.

- Monitor product quality trends and identify potential quality risks before they impact customers.

- Review Annual Product Quality Reviews / Product Quality Reviews and drive improvement actions.

- Exercise independent Quality authority for decisions involving product release, rejection, investigation, or recall.

Regulatory Compliance & Inspection Readiness:

- Ensure organizational readiness for domestic and international regulatory inspections and customer audits.

- Lead the Quality organization during inspections and audits involving applicable EU, USFDA, CE/MDR and other global regulatory requirements.

- Maintain continuous inspection readiness rather than event-based audit preparation.

- Ensure timely and effective closure of regulatory observations and audit findings.

- Partner with Regulatory Affairs to interpret evolving regulatory requirements and translate them into operational Quality systems.

- Benchmark the organizations Quality systems against global GMP and medical device quality expectations.

Validation & Qualification:

- Provide Quality oversight for facility, equipment, utility, process, cleaning, analytical method, and computerized system validation as applicable.

- Ensure validation master plans and protocols are scientifically robust and regulatory compliant.

- Review and approve qualification and validation documentation.

- Ensure continued validated state of critical processes, equipment, utilities, and systems.

Customer Complaints, PMS & Quality Risk:

- Ensure timely investigation of customer complaints and product quality concerns.

- Oversee trend analysis of complaints, deviations, non-conformances, and market feedback.

- Partner with Regulatory Affairs and Technical teams for post-market surveillance and vigilance activities, where applicable.

- Lead product recall and crisis-quality management processes when required.

- Ensure CAPAs address systemic root causes rather than individual incidents.

Supplier & External Quality Management:

- Establish supplier qualification, evaluation, audit, and monitoring systems.

- Ensure Quality oversight of raw material suppliers, packaging vendors, contract manufacturers, testing laboratories, and critical service providers.

- Establish supplier Quality Agreements where required.

- Drive supplier CAPA and continuous improvement programs based on risk and performance.

Quality by Design & New Product Development:

- Partner with R&D, Technical, Production, and Regulatory teams during new product development and commercialization.

- Ensure Quality requirements are incorporated from product concept through scale-up and commercial manufacturing.

- Provide Quality oversight for technology transfer, process validation, specifications, analytical methods, and product launch readiness.

- Ensure quality and regulatory risks are identified early during product development.

Continuous Improvement & Quality Excellence:

- Drive a proactive Quality culture focused on prevention rather than correction.

- Use Quality data, trend analysis, and risk-based approaches to identify systemic improvement opportunities.

- Drive reduction in deviations, recurring CAPAs, complaints, OOS, rejection, and quality-related losses.

- Promote Right-First-Time, Lean Quality, and continuous improvement practices.

Team Leadership & Capability Development:

- Lead the complete QA, QC, and Microbiology organization.

- Develop strong second-line leadership across the three Quality functions.

- Define clear accountability, performance expectations, and development plans for Quality teams.

- Build technical and regulatory capability through structured training and knowledge development.

- Ensure succession planning for critical Quality positions.

- Foster a culture of scientific rigor, integrity, accountability, and continuous learning.

Requirements and Skills:

- Bachelors / Masters degree in Pharmacy, Chemistry, Microbiology, Biotechnology, Life Sciences, or related discipline.

- 15+ years of progressive Quality experience within pharmaceuticals, medical devices, infection prevention, disinfectants, healthcare manufacturing, 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, preferably 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.

- Ability to influence senior stakeholders while maintaining the independence and integrity of the Quality function.