Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

Your key responsibilities:
Your responsibilities include, but not limited to:

• 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.

Minimum requirements

What you'll bring to the role:

• 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:

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

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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

Novartis Technical Operations

Business Unit

NTO QUALITY

Employment Type

Regular

Commitment to Diversity & Inclusion:

Novartis is 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