PHARMAFull-time
Specialist, Quality Operations
HYDERABAD (IN)HYBRIDPOSTED: 9/1/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVARTISPharmaceuticals / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Job Description Summary
Responsible for end-to-end supplier, vendor, and third-party quality management activities.
The position is based in Hyderabad, India, and Novartis states that relocation support is not available.
Core Responsibilities — Supplier Quality Management
Draft and author Annual Monitoring and Certification reports for incoming materials.
Draft, negotiate where applicable, and archive Quality Assurance Agreements with suppliers and service providers.
Evaluate and manage Supplier Change Notifications (SCNs) and initiate the appropriate quality records for applicable changes.
Draft and evaluate supplier incoming-material specifications.
Perform Quality Risk Assessments (QRAs) for existing and new suppliers and service providers.
Manage supplier/material qualification activities and supplier-related documentation.
Prepare regulatory statements for materials and finished products.
Manage quality records and support the Service Delivery Team with quality-related topics and Third Party Assurance Program (3rdPAP) management in the Third Party Risk Management (TPRM) tool.
Coordinate with stakeholders through the Supplier Information Management (SIM) approval process for quality deliverables.
Prepare relevant contributing reports for applicable APQR sections.
Evaluate change-control tasks and deviations related to supplier quality management.
Coordinate the handling of discrepant materials and supplier complaints.
Audit, CAPA & Quality-System Responsibilities
Support audit preparation activities.
Perform QARP and FURP responsibilities for audit and CAPA management.
Serve as the designated functional representative for applicable activities.
Deliver end-to-end supplier quality management activities according to delegated responsibilities from the business partner.
Qualifications & Education
Preferred experience: approximately 8 years.
Education: M.Pharm, B.Pharm, MSc, or equivalent qualification from a reputed university.
English language proficiency required.
Quality & Compliance Expertise
Work across supplier quality management, Quality Assurance, Quality Control, Quality Management Systems, regulatory compliance, GMP, SOPs, internal quality auditing, and quality compliance.
Apply quality-risk principles to supplier qualification, supplier changes, specifications, deviations, complaints, and quality records.
Maintain data integrity and support compliant quality documentation and audit readiness.
Contribute to operational excellence and Statistical Process Control activities where applicable.
Collaboration & Business Impact
Collaborate with suppliers, service providers, business partners, Service Delivery Teams, and internal quality stakeholders.
Coordinate quality deliverables across supplier-information and third-party-risk-management processes.
Support compliant supply of incoming materials and finished products through effective supplier oversight.
Contribute to APQR, CAPA, audits, change control, deviation management, and supplier complaint resolution.
Novartis Culture & Benefits
Novartis states that its purpose is to reimagine medicine to improve and extend people's lives and its vision is to become the most valued and trusted medicines company in the world.
The company highlights an inclusive work environment and diverse teams representing the patients and communities it serves.
Novartis provides benefits and rewards through its Life Handbook.
REQUIRED VERIFIED SKILLS
M.Pharm/B.Pharm/MSc or equivalent
Approximately 8 years preferred experience
Supplier Quality Management
Quality Assurance
Quality Control
Quality Management Systems
GMP
Regulatory Compliance
Quality Compliance
Data Integrity
SOP
Quality Risk Assessment
Supplier Qualification
Supplier Change Notification
Change Control
Deviation Management
Supplier Complaints
CAPA
APQR
Audit Readiness
English
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
The supplied Novartis posting does not disclose a salary range, bonus, or specific monetary compensation figures, so salary fields are left blank. The stated preferred experience is around 8 years and the required qualification is M.Pharm, B.Pharm, MSc, or equivalent. Candidates should evaluate the complete Novartis rewards package, including base compensation, applicable incentives, benefits, and other employee programs, rather than relying on an estimated salary figure.
ORGANIZATION CONTEXT & CULTURE
Novartis AG is a Swiss multinational pharmaceutical corporation, one of the largest in the world. It focuses on discovering, developing, manufacturing, and marketing innovative medicines to address significant health needs. The company's portfolio spans various therapeutic areas including oncology, immunology, neuroscience, and cardiovascular diseases.
TEAM SIZE: 76,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare
EXPECTED CAREER ROADMAP
This role offers progression within supplier quality, quality assurance, quality compliance, quality systems, third-party quality management, and broader pharmaceutical quality leadership. Experience across supplier qualification, change notifications, risk assessments, audits, CAPA, deviations, APQR, and regulatory documentation can support progression toward Senior Specialist, Associate Manager, Quality Assurance Manager, Supplier Quality Manager, Quality Systems leadership, or global quality-management positions. The end-to-end supplier and third-party scope also provides opportunities to develop into strategic supplier-quality, quality governance, and operational-excellence roles.
APPLICATION ADVISORY
Highlight 7-10 years of relevant pharmaceutical Quality/Supplier Quality experience if applicable, with supplier and third-party quality management clearly visible. Emphasize B.Pharm, M.Pharm, MSc, or equivalent qualifications. Showcase hands-on experience with supplier qualification, Quality Risk Assessments, Supplier Change Notifications, Quality Assurance Agreements, material specifications, deviations, complaints, CAPA, APQR, audits, and regulatory statements. Mention experience with QMS, GMP, SOPs, data integrity, internal auditing, TPRM, SIM, and quality documentation systems. Quantify improvements such as supplier performance improvements, audit findings closed, CAPA cycle-time reduction, complaint-resolution improvements, or successful qualification activities. Prepare examples demonstrating cross-functional collaboration, risk-based decision making, managing ambiguity, and maintaining compliance under changing supplier conditions.
RECOMMENDED TRAINING
1/5
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