Quality Assurance Manager - Pharmaceutical External Supplier Management

Novartis India; Mumbai; Presencial; INR 2 500 000 - 4 000 000; Tempo integral

Resumo da oferta

Novartis India seeks a Manager, Quality Assurance to oversee quality at external suppliers, ensuring cGMP compliance with the Quality Manual and regulatory standards across manufacturing and distribution.

The role leads supplier qualification, QA audits, CAPA execution, risk assessments, and continuous improvement in quality systems. Mumbai-based with global quality exposure and strong collaboration skills.

Qualificações

• University degree in science (chemistry, pharmacy) and/or business administration advantageous.
• Experience in QC, QA Operations and Auditing.
• Thorough knowledge of cGMP requirements.

Responsabilidades

• Lead External Suppliers Qualification process.
• SPOC for all quality activities at External Supplier.
• Ensure compliance with cGMP and Quality Manual per SOPs.
• Provide QA leadership for technology transfer with external suppliers.
• Review transfer protocols, risk assessments, and transfer reports.
• Drive External Supplier Quality Risk assessments.
• Coordinate supplier audits and CAPA follow-up.
• Handle critical quality issues per Quality Agreement.
• Support Emergency Management cases as required.
• Assess quality trends and drive continuous improvement.

Conhecimentos

Collaboration

Communication

Continuous Improvement

Data Integrity

Decision Making

GMP

Problem Solving

Process Improvements

Project Management

Quality Assurance

Quality Management Systems

Regulatory Compliance

Risk Management

Formação académica

Science degree (Chemistry/Pharmacy)

Business Administration

Descrição da oferta de emprego

Manager, Quality Assurance Job Description Summary

Responsible for managing quality aspects at external suppliers for pharmaceutical products and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements, and the Novartis Pharma Quality Manual and is conducted according to the relevant SOPs

Job Description

Key Requirements: Lead External Suppliers Qualification process. Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier. Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs Provide quality leadership and oversight for technology transfer activities involving external suppliers, ensuring successful transfer of products, processes, analytical methods, specifications, and relevant documentation in compliance with Novartis Quality Standards, Quality Agreements, and regulatory expectations. Review and approve technology transfer protocols, risk assessments, validation strategies, comparability evaluations, and transfer reports, ensuring readiness for commercial manufacturing and supply. Responsible for driving / initiating External Supplier Quality Risk assessments for all External Suppliers. Gaps in Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed. Provide the quality presence and in-put to technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals. Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Novartis Quality Manual - maintain an annual auditing program, participate in audits, manage action plans and follow up on CAPAs. Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Escalate any issues or instances of instability per the Novartis escalation policy and initiate any market action that is required. Support / participate in Novartis Emergency Management cases as required. Ensure that Change requests, either from the External Supplier or from Novartis, are managed according to the Quality Agreement and Novartis SOPs from receipt, through to the implementation and closure. Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance.

Essential Requirements

University degree in science (chemistry, pharmacy) and/or business administration advantageous. Minimum 10 years, in the pharmaceutical industry, with direct experience with pharmaceutical products. Experience in QC, QA Operations and Auditing. Thorough knowledge of cGMP requirements

Desirable Requirements

Strong understanding of regulatory requirements for commercial products Proven track record with FDA, EMA and other Health Authorities. Understanding of risk assessment and risk management fundamentals/tools. Technical understanding of pharmaceutical processes.

Skills Desired

Collaboration, Communication, Continuous Improvement, Data Integrity, Decision Making, Good Manufacturing Practices (GMP), Problem Solving, Process Improvements, Project Management, Quality Assurance (QA), Quality Assurance Systems, Quality Compliance, Quality Management, Quality Management Systems (QMS), Regulatory Compliance, Risk Management

Experience Level

Mid Level