Job Description

About the role

Quality Assurance Manager - ESO API

Location - Mumbai

About the Role:
This position is responsible for ensuring quality oversight for purchased API\'s and strategically important regulatory starting materials and chemical intermediates supplied into Novartis NTO sites worldwide..
Key Responsibilities:

• Approve and maintain quality oversight with respect to supply of materials to Novartis, from global external suppliers of chemicals (strategic raw materials, Intermediates and Drug Substances) by working in Supply Relationship Teams. These materials are being supplied to >75 Novartis Technical Operation sites. To ensure appropriate quality oversight, assessment and mitigation of quality risks that may potentially negatively impact the supply of purchased strategic ESO chemicals (regulatory starting materials, intermediates and API\'s), and to ensure that all aspects of the relationship and management thereof, are in compliance with cGMP\'s, legal and regulatory requirements, the Novartis Quality Manual and Policies.
• Responsible for ensuring quality oversight for purchased API\'s and strategically important regulatory starting materials and chemical intermediates supplied into Novartis NTO sites worldwide. Participates in and approves changes of supplier qualification and certification status for all external Suppliers, and maintain all associated quality systems e.g. maintain and update documents related to the supplier qualification and monitoring.
• Participate in escalation of all potential quality issues as per the Novartis escalation policy to higher level management. Manage major and critical quality issues (Complaints, deviations, recalls, stability failures and any regulatory non-compliance identified, as applicable) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed.
• Perform risk assessments in case of specific quality events at supplier, including collecting relevant data from NTO sites and other stakeholders, and approval of site specific risk assessments where required. Evaluates risks for product quality and patient safety and proposes market actions. Provide direction and support to third parties and ensure that they are qualified, achieve a high level of competence and are motivated to carry out their duties to ensure that the materials produced meet the Novartis quality, efficacy and safety requirements.
• Travel to external suppliers manufacturing sites during audits, continuous improvement activities or to resolve any issues. Responsible for preparing Quality Agreements and Quality Risk assessments for all External Suppliers within the responsibility of the team, and for maintaining of documentation in relevant IT systems. Support remediation of any gaps identified in Quality Systems and ensure any issues are 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 and/or lead audits, manage action plans and follow up on agreed upon CAPAs (QARP, FURP).
• Ensure that Change requests, either from the External Supplier or from Novartis, are raised in the Novartis Change Control system, or where applicable, are managed according to the Quality Agreement and Novartis SOPs from receipt, through to the implementation and closure.
• 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, Group Quality Operations (GOO), etc. Support site readiness for regulatory inspections at External suppliers where appropriate, and support site remediation from inspections where required. Ensure that support is provided to NTO sites in their preparation for Novartis or Health Authority general GMP inspections and PAI inspections. Support Regulatory CMC in compilation of responses to HA queries and review source documents for Regulatory submissions as required.

Role Requirements

Essential Requirements:

• 15 years\' experience in the pharmaceutical industry, with direct experience with API\'s. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience.
• Thorough knowledge of cGMP requirements. Strong understanding of regulatory requirements for commercial products.
• Proven track record with FDA, EMEA and other Health Authorities. Strong understanding of risk assessment and risk management fundamentals/tools.
• Strong Technical understanding of pharmaceutical processes. Team and consensus builder, with definitive and authoritative decision making ability.

Desirable Requirements:

• Bachelor or higher degree; preferred in Biochemistry, Chemistry or another related science

Why Novartis: Our purpose is to reimagine medicine to improve and extend people\'s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You\'ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

Functional Area

Quality

Division

Operations

Business Unit

QUALITY

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Novartis