Job Description

About the role

Global GMP Quality Auditor

Location - Mumbai #LI Hybrid

About the Role:

Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.

Ensure alignment with strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to Novartis business units through risk based assessments. Act as SME for assigned areas of responsibility.

Key responsibilities:

• Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
• Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents. For this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these operations is critical to success.
• Provide technical guidance, mentoring, and training on audit activities. Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing. Prepare audit reports according to NVS requirements and timelines.
• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee. Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed.
• Review and advise on relevant policies and procedures. Mentor junior GMP staff as required. Maintain current knowledge of regulations, standards, and guidance documents. Identify and report best practices and lessons learned to support development/training of GMP auditors.

Role Requirements

Essential Requirements:

• Experience/ expertise in Low bioburden products/ Biotherapeutics/ Cell & Gene therapy/ x RNA technologies/ Radiopharmaceuticals is critical for the role.
• 12 years broad experience in Pharmaceutical or Medical Device Industry.

The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.

• 8 years GMP auditing experience preferred, and excellent knowledge of regulatory requirements. Willingness to travel approximately 60% of the time.
• Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
• Experience and/or interaction with local Health Authority and sporadically with other Health Authorities. Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.
• Sound and practical judgement in the interpretation and application of regulations and standards. Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision. Excellent leadership and facilitation skills

Desirable:

• Degree in Chemistry, Pharmacy, Biology, Engineering, Natural/Biological Science or another related science. Advanced degree preferred. Other degrees with relevant experience is good to have.
• Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is preferred.

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