Job ID
367484BR

Mar 14, 2023

India

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:

• Responsible for managing quality aspects at external suppliers for Biopharmaceuticals / Pharmaceutical / Devices 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. 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 biopharmaceutical / 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.
• Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are 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.
• Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements. Approve Quality Agreement on behalf of the QA Lead. Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
• 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. Ensure site readiness for regulatory inspections at External suppliers where appropriate. Manage/Approve 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. Ensure all required actions are taken appropriately and in a timely fashion.
• Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing (FAR/BPDR) accordingly. 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. Is the Quality representative on the Quality/Business Management Meetings for External Supply, and ensures robust review and escalation of critical quality issues arising within the area of responsibility.

• Stability reports and PQR\xe2\x80\x99s, Ensure that the External Supplier provides the required product review or the data as specified in the relevant Quality Agreement on an annual basis. Critically assess the performance of the product and process and provide the assessment to the report annually. Approve PQR\xe2\x80\x99s on behalf of the QA Lead. Support due diligence activities and provide External Supply QA recommendation (auditing, technical and quality assessments). Act as Key QA contact for ESO Sourcing/Strategy (and/or Business Development & Licensing) for the technologies in use in his QA organization. Support launches of product in close collaboration with BD& L partner and/ or development organization. Support transfer of products in close collaboration with ESO MS&T and with QA from donor site. Ensure External Supplier readiness for commercial manufacturing starting from validation activities. Assess and ensure External Supplier readiness for HA inspections (PAI, directed, other).

Diversity & Inclusion / EEO

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

Minimum Requirements

What you\xe2\x80\x99ll bring to the role:

• 15 or more years\xe2\x80\x99 experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA of finished doses forms, 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

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we\xe2\x80\x99re proud of this, we know there is so much more we could do to help improve and extend people\xe2\x80\x99s 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\xe2\x80\x99s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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


Division
Novartis Technical Operations
Business Unit
QUALITY
Location
India
Site
Mumbai
Company / Legal Entity
Nov Ind
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No