Manufacturing Quality Assurance Specialist
Novartis
Summary
Quality is not just a checkpoint here—it is the promise we make to patients. As a Manufacturing Quality Assurance Specialist at Novartis, you will be a hands-on partner to manufacturing teams, ensuring every stage of production meets the highest standards of quality, compliance, and scientific rigor. From shop floor presence to final product release, your expertise will directly influence patient safety and product integrity while helping drive continuous improvement in a fast-paced, purpose-driven manufacturing environment.
Job description
Job Description Summary
Quality is not just a checkpoint here—it is the promise we make to patients. As a Manufacturing Quality Assurance Specialist at Novartis, you will be a hands-on partner to manufacturing teams, ensuring every stage of production meets the highest standards of quality, compliance, and scientific rigor. From shop floor presence to final product release, your expertise will directly influence patient safety and product integrity while helping drive continuous improvement in a fast-paced, purpose-driven manufacturing environment.
Key Responsibilities
- Provide proactive quality oversight through shop floor presence, walkthroughs, and real-time manufacturing support.
- Review and approve master and executed batch records to ensure compliant clinical and commercial production.
- Partner with manufacturing teams to ensure consistent, compliant processes aligned with GMP requirements.
- Support media, buffer, cell expansion, upstream, downstream, and aseptic filling manufacturing operations.
- Lead deviation and corrective action investigations, ensuring thorough root cause analysis and effective remediation.
- Review alarms, data integrity, and electronic records to confirm accuracy and regulatory compliance.
- Support internal and external audits, inspections, and regulatory readiness activities.
- Provide quality expertise in manufacturing batch record design, review, and continuous improvement.
- Analyze quality metrics, identify trends, and communicate actionable insights to management.
- Lead or contribute to continuous improvement and quality system enhancement projects.
Essential Requirements
- Bachelor of Science degree in microbiology, chemistry, biochemistry, or a related scientific discipline.
- Minimum of five years of experience working in a regulated GMP manufacturing environment.
- Strong working knowledge and application of CFR, FDA, and EU regulatory requirements.
- Proven experience supporting or participating in FDA and EU regulatory inspections and audits.
- Hands-on experience reviewing, authoring, and approving quality procedures and standard operating documents.
- Demonstrated ability to manage deviations, investigations, and corrective and preventive actions to closure.
- Strong analytical skills with the ability to interpret data, identify trends, and recommend compliant paths forward.
- Excellent written and verbal communication skills with the ability to collaborate effectively across functions.
Desirable Requirements
- Experience supporting viral gene therapies or orphan disease manufacturing programs.
- Experience leading or coordinating internal quality audits and inspection readiness activities.
Requirements
- Bachelor of Science degree in microbiology, chemistry, biochemistry, or a related scientific discipline
- Minimum of five years of experience working in a regulated GMP manufacturing environment
- Strong working knowledge and application of CFR, FDA, and EU regulatory requirements
- Proven experience supporting or participating in FDA and EU regulatory inspections and audits
- Hands-on experience reviewing, authoring, and approving quality procedures and standard operating documents
- Demonstrated ability to manage deviations, investigations, and corrective and preventive actions to closure
- Strong analytical skills with the ability to interpret data, identify trends, and recommend compliant paths forward
- Excellent written and verbal communication skills with the ability to collaborate effectively across functions
Benefits
- Health benefits
- Life insurance
- Disability benefits
- 401(k) with company contribution and match
- Performance-based cash incentive
- Annual equity awards
- Vacation
- Personal days
- Holidays
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.