Manager, Quality Assurance

Novartis AG; Mumbai; On-site; INR 2,500,000 - 5,000,000; Full time

Job summary

Novartis Healthcare Private Limited in Mumbai seeks an experienced professional to oversee quality aspects at external suppliers for pharmaceutical products. You will ensure adherence to cGMP, Quality Agreements, regulatory requirements, and Novartis Quality Manual, conducting activities under local SOPs.

The role includes leading supplier qualification, managing technology transfer quality, reviewing protocols and risk assessments, driving supplier quality risk programs, and coordinating

Qualifications

• University degree in science (chemistry, pharmacy) and/or business administration advantageous.
• Minimum 10 years in the pharmaceutical industry with direct QA/QC/Auditing experience.
• Strong knowledge of cGMP and regulatory requirements (FDA, EMA).
• Experience with technology transfer and external supplier management.

Responsibilities

• Lead External Suppliers Qualification process and act as SPOC for all quality activities at External Supplier.
• Provide quality leadership for technology transfer involving external suppliers.
• Review transfer protocols, risk assessments, validation strategies, comparability evaluations, and transfer reports.
• Drive External Supplier QA risk assessments and remediation plans.
• Coordinate and ensure Quality auditing of External suppliers and manage CAPAs.
• Manage critical quality issues and escalate per policy; support emergency management as needed.
• Implement and maintain a local Quality System and SOPs; keep QA Lead and Supplier Relationship Manager informed.
• Participate in business reviews and KPI reporting with External suppliers.

Skills

Quality leadership

Regulatory knowledge

Risk assessment

Communication

SOP adherence

Education

Science degree (Chemistry/Pharmacy) or MBA (advantageous)

Job description

About the role:
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

About the Role

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 arecorrectly 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.


• Within the organization: Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers. Ensure that the QA Lead and the Supplier Relationship Manager is kept informed of all critical and major issues which may have an adverse effect on the quality of the product at an External Supplier.


• Together with the Supplier Relationship Manager provide direction, formulate strategies and make decisions which ensure the efficient operation of the External Supplier business as a whole - Participation in the Business review of External suppliers.


• Participate in the Reporting on QA External Supplier activities - this is to include Risk Assessment, reporting and managing of defined KPI’s. Ensure that coordinated contact is maintained with other functions within Novartis also dealing with External suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Quality Operations (QOP), etc.


• Participate in the ESO Quality Plan – ensure that all quality issues at External suppliers are included in this plan. Participate in projects as defined and ensure that all aspects are implemented and followed up.


• 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


• 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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area Quality

Job Type Full time

Employment Type Regular

Shift Work No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.