Job Description Summary
The Specialist - Quality Operations supports in batch release preparatory activity, QMS activity and Regulatory compliance check.
Job Description
Major accountabilities:
Perform Quality Operations activities supporting product quality, batch release, and regulatory compliance processes.
Execute batch release preparatory activities, technical release verification, and regulatory compliance checks according to defined procedures.
Ensure compliance with GxP requirements, Novartis quality standards, regulatory requirements, and internal operating procedures.
Create, review, and maintain GxP documentation, including SOPs, working procedures, trend reports, investigations, and qualification reports.
Support Quality Management System (QMS) activities, including deviation management, quality events, and compliance follow-up actions.
Generate, analyze, and interpret reports from approved systems to drive operational monitoring and informed decision-making.
Support master data management, BOM approval activities, Certificate of Analysis (CoA) generation, and other quality-related processes.
Escalate and support the investigation of GxP and non-GxP issues, ensuring timely resolution and compliance.
Provide support during internal and external audits through data collection, reporting, and presentation of quality documentation.
Deliver accurate and timely results while supporting KPI reporting, digital/data-driven initiatives, and additional business or departmental requirements.
Essential requirements:
Bachelor's or Master's Degree in Pharma or equivalent.
5-7 years of experience within a GMP Quality Assurance department with a focus on batch release activities.
Experience with QMS processes, particularly deviations, quality events and compliance activities.
Exposure to regulatory compliance or regulatory affairs activities.
Clear and effective communication in English.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.
Accessibility and Accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Collaboration, Communication, Data Integrity, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)Skills Required
- Bachelor's or Master's Degree in Pharma or equivalent
- 5-7 years of experience within a GMP Quality Assurance department, focused on batch release activities
- Experience with QMS processes, particularly deviations, quality events, and compliance activities
- Exposure to regulatory compliance or regulatory affairs activities
- Clear and effective communication in English
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
