Highlights
Ensure that coordinated contact is maintained with all parties (the Regulatory Authorities, the local partners and stakeholders and Global QA).Essential requirements:Scientific University Degree.+5 years of experience within the Quality Assurance and/or Regulatory Affairs department of a multinational pharmaceutical company. Major Accountabilities: Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
Numbers & Facts
| Location | Durham, NC |
| Industry | Biotechnology/Pharmaceuticals |
| Company Size | 10,000 employees or more |
| Year Founded | 1996 |
Description
Job ID
REQ-10084339
Aug 03, 2026
Egypt
Available in: English
Summary
#LiHybridThe NCQ Manager is responsible to ensure that the product, processes and procedures conforms with GxP and local specifications and that production activity is compliant with Novartis quality policy and GxP requirements. To ensure that relevant documentation is up-to-date and archived correctly and "state of the art" GxP know-how and future trends in the field of GxP.
About the Role
Major Accountabilities: Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self-Inspection schemes for all sections.Monitor actions and corrections accordingly.Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely manner.Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation.Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of Pharmaceutical products -Support launches of product in close collaboration with BDand L partner and/ or development organization.Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.Ensure that coordinated contact is maintained with all parties (the Regulatory Authorities, the local partners and stakeholders and Global QA).Essential requirements:Scientific University Degree.+5 years of experience within the Quality Assurance and/or Regulatory Affairs department of a multinational pharmaceutical company.Deep GMP/GDP knowledge.Strong local and global stakeholder management skills.Fluent in English.Commitment to Diversity & InclusionNovartis is a proud member of the ILO Global Business and Disability Network and the Valuable 500, promoting the inclusion of people with disabilities in workplaces around the world. We also collaborate with international partners, such as Disability: IN, Purple Space, and Business Disability Forum to identify and develop best practice solutions to enable people with disabilities to participate as equal members of our organization.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.Read our handbook (PDF 30 MB)
Division
Operations
Business Unit
Quality
Location
Egypt
Site
New Cairo
Company / Legal Entity
EG02 (FCRS = EG002) Novartis Pharma S.A.E
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
Quality Operations Egypt
Job ID
REQ-10084339
NCQ Manager
Apply to Job
Job ID
REQ-10084339
NCQ Manager
Apply to Job
About Company
Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.