Novartis QA Compliance Jobs | Chemistry Candidates Apply Now
A rare chance has emerged at Novartis for a QA Compliance Expert – Regulatory CMC Facilitator in Hyderabad, India. This role is pivotal in ensuring regulatory compliance and product lifecycle management.
Job Title: QA Compliance Expert – Regulatory CMC Facilitator
Job ID: REQ-10087109
Location: Hyderabad, India
About Novartis:
Novartis is a global healthcare company based in Switzerland, focused on innovative medicines and improving patient outcomes. The organization operates in various therapeutic areas, including oncology, cardiology, immunology, and neuroscience. With a commitment to research and development, Novartis aims to deliver high-quality healthcare solutions to patients worldwide.
Job Details:
QA Compliance Expert Job Description
As a QA Compliance Expert – Regulatory CMC Facilitator, the selected candidate will play a crucial role in ensuring patients worldwide receive medicines without interruption. The expert will partner with global stakeholders to navigate complex Chemistry, Manufacturing, and Control requirements, influencing strategic decisions and driving regulatory excellence in a collaborative, international environment.
Key Responsibilities
- Partner with regulatory teams to align Chemistry, Manufacturing and Control strategies across the product lifecycle.
- Evaluate product changes for regulatory impact and support compliant change control decisions.
- Serve as the primary site contact for regulatory matters and cross-functional stakeholder engagement.
- Provide regulatory guidance during quality events, investigations, escalations, and compliance discussions.
- Coordinate timely reviews of Chemistry, Manufacturing and Control documentation for assigned products.
- Support regulatory inspections and audits by identifying and addressing compliance risks.
- Drive initiatives that strengthen regulatory compliance and promote process harmonization.
- Deliver training and knowledge sharing to enhance regulatory awareness across site functions.
QA Compliance Expert Eligibility Criteria
- Advanced degree in Chemistry, Biology, Pharmacy, Engineering, or a related scientific discipline.
- More than three years of experience in a Good Practice regulated environment.
- Experience in Quality Assurance, Manufacturing, Development, or Regulatory Affairs within the pharmaceutical industry.
- Strong knowledge of biologic drug substance manufacturing processes involving recombinant proteins or nucleic acids.
- Ability to work independently, manage complex priorities, and make sound quality decisions.
- Fluent English communication skills with the ability to collaborate across global teams.
This opportunity at Novartis for a QA Compliance Expert – Regulatory CMC Facilitator is a significant step for qualified candidates aiming to make an impact in the pharmaceutical industry. Interested individuals are encouraged to apply before the deadline on 23 September 2026.
