R&D Quality Manager

5+ years

Not Disclosed

Hyderabad

10 March 4, 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

Job ID: REQ-10039553
Location: Hyderabad, India
Category: Quality
Business Unit: Innovative Medicines
Job Type: Full-time, Regular
Company: Novartis Healthcare Private Limited

Role Summary:

The R&D Quality Manager is responsible for investigating and managing technical complaints related to Investigational Medicinal Products (IMPs) and Medical Devices raised by clinical investigator sites. This role also supports data integrity (DI) incidents, manages escalations, and contributes to global DI networks and initiatives.

Key Responsibilities:

Technical Complaints Management:

Investigate technical complaints, determine root causes, and implement corrective actions to prevent recurrence.
Collaborate with cross-functional teams to perform Root Cause Analysis (RCA) and identify potential failure points.
Review and approve complaint investigations as the site investigation approver.
Manage multiple investigations simultaneously, ensuring timely completion.
Analyze complaint trends periodically to identify recurring issues and develop proactive solutions.

Data Integrity & Compliance:

Handle data integrity (DI) escalations and ensure compliance with global DI standards.
Implement and drive global Data Integrity (DI) network initiatives.
Support audit and inspection readiness activities, ensuring adherence to cGMP and regulatory requirements.

Qualifications & Experience:

Essential Requirements:

14+ years of experience in the chemical/pharmaceutical industry or 5+ years in pharmaceutical operations.
Strong knowledge of pharmaceutical facilities, manufacturing, and laboratory systems.
Expertise in Root Cause Investigations (RCI) and collaboration with investigation teams.
Hands-on experience in cGMP manufacturing, Quality, and Compliance.
Experience handling Peptides, Biologics, Small Molecules, and CGT products.
Strong skills in problem-solving, relationship-building, planning, conflict management, coaching, and analytical thinking.
Project management expertise with a results-oriented mindset.
Sound knowledge of international regulatory regulations, cGxP requirements, and EU-GMP guidelines.

Desirable Skills:

Ability to manage multiple investigations and communicate challenges proactively.
Fast learner with experience in medical devices, packaging, and distribution-related topics.
Excellent verbal and written communication skills with the ability to present findings effectively.

Commitment to Diversity & Inclusion:

Novartis is committed to fostering an inclusive work environment and providing reasonable accommodations for individuals with disabilities.

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R&D Quality Manager

Job Description

Role Summary:

Key Responsibilities:

Technical Complaints Management:

Data Integrity & Compliance:

Qualifications & Experience:

Essential Requirements:

Desirable Skills:

Commitment to Diversity & Inclusion:

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