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R&D Quality Manager

5+ years
Not Disclosed
10 June 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

R&D Quality Manager – Hyderabad, India

Job Summary:

Novartis is hiring an R&D Quality Manager to join their Hyderabad office. The role involves managing quality assurance (QA) projects, ensuring cGMP compliance in technical research and development (TRD), and supporting product development activities. Ideal for professionals with solid GMP knowledge and QA expertise in the pharmaceutical industry, this position offers the opportunity to contribute to global quality standards in innovative drug development.


Key Responsibilities:

  • Lead and support low-complexity independent projects and assist in complex projects under mentoring.

  • Manage failure investigations, deviations, change controls, and routine quality tasks.

  • Ensure compliance with cGMP and project quality deliverables by reviewing and approving GMP-relevant documents and tools.

  • Provide functional QA expertise to Line Units and other quality units.

  • Handle TRD product portfolios, implement quality manuals, and manage risk assessments and training.

  • Support project management as a team member across quality improvement activities.

  • Comply with internal/external quality, regulatory, and safety guidelines (e.g., SOPs, cGMP).

  • Evaluate and enhance quality systems for consistent regulatory compliance.


Required Skills & Qualifications:

  • Master’s/Bachelor’s/Technician degree in Pharma or related field (5+ years of pharma industry experience).

  • Fluent in English (oral & written); local language skills desirable.

  • In-depth knowledge of cGMP and technical development, production, or QA processes.

  • Strong scientific, technical, and regulatory understanding.

  • Excellent organizational and decision-making abilities.

  • Proficiency in analyzing and evaluating GMP compliance issues.


Perks & Benefits:

  • Opportunity to work with one of the world's leading pharmaceutical companies.

  • Professional development and training programs.

  • Inclusion in global projects with cross-functional exposure.

  • Comprehensive healthcare, wellness, and retirement plans.


Company Description:

Novartis is a globally recognized pharmaceutical leader committed to innovation in research and development. The company strives to create breakthrough treatments and improve patient outcomes worldwide, fostering a collaborative and inclusive work environment.


Work Mode:

On-site (Hyderabad Office)


Call to Action:

Are you ready to drive quality excellence in drug development? Apply now to become an R&D Quality Manager at Novartis and make a difference in global healthcare!