The Quality Assurance Manager of Combination Products will be responsible for providing quality oversight of Novartis suppliers and support for Novartis combination product development efforts throughout clinical development, product registration, commercialization, and lifecycle management.
The Manager reports to the Sr. Manager of Quality Operations U.S. Third Party Products. The Manager is responsible for supporting the start-up and routine manufacture of a new sterile injectable generic product. Responsibility will include key roles in the end to end quality management for a new generic product manufactured at multiple contract manufacturing organizations. Quality management will include drug substance manufacturing, drug product manufacturing, analytical testing, components, and raw materials.
Responsibility will include key roles in the end to end quality management for generic products manufactured at multiple contract manufacturing organizations. Quality management will include support of one or more of the following areas: drug substance manufacturing, drug product manufacturing, analytical testing, components, and raw materials. Responsible for: 1. Performing SOP and batch record review and approval. 2. Authoring deviations. 3. Monitoring root cause occurrence rate and ensuring CAPA effectiveness. 4. Authoring change control documents for manufacturing changes. 5. Authoring root cause and CAPA summaries for technical complaints. 6. Authoring sections of Annual Product Review Reports. 7. Serving as quality representative for the organization when interacting with suppliers and contract service providers. 8. Developing and implementing Quality Agreements with service providers and performing service provider quality evaluations. 9. Monitoring and providing monthly quality metrics. 10. Working with Technical Operations to provide quality guidance during project implementation. 11. Working with Supply Chain and Purchasing to assure rapid/appropriate response to quality related events. 12. Leading continuous improvement projects and using lean six-sigma tools/methodologies. Essential Job Functions:
Ensure product quality at the best value.
Build and maintain working relationships with partners and contract manufacturing organizations.
Provide quality assurance for products by conducting risk-based quality assessments.
Metric quality systems and lead continuous improvement projects.
Travel 20 to 35% of time to perform quality responsibilities.
Manage 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.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
B.S. Degree in Science or Engineering with a minimum of 8 years of pharmaceutical industry experience. (Experience can include manufacturing, technical operations, validation, or quality).
Written and oral English
Experience working on cross-functional teams.
Experience leading and implementing projects. Preferred but not required:
Experience with sterile operations including deviations, batch records, validation, equipment sterilization, environmental monitoring, aseptic manufacturing, analytical release testing.
Six Sigma Green Belt or Black Belt certification.
American Society for Quality CQM/CQE/CQA or similar certification. Skills & Competencies:
Knowledge of quality systems, code of federal regulations, and industry guidance for sterile and non-sterile pharmaceutical manufacturing.
Excellent verbal/written communication and decision making skills.
Strong project management skills.
Knowledge of quality by design principles and how to define critical process parameters.
Strong understanding of regulatory requirements for commercial products
Proven track record with FDA, EMEA and other Health Authorities.
Strong understanding of risk assessment and risk management fundamentals/tools
Strong Technical understanding of pharmaceutical processes
Team and consensus builder, with definitive and authoritative decision making abilities
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