| || Come to an industry leader where you will manage the stability program to ensure the compliant and timely design, interpretation and reporting of stability studies for pharmaceutical drug products as well as preparation and distribution of Testing Monographs, ensure that all documents satisfy current GMP and regulatory requirements, requests from Health Authorities, general (ICH, FDA, etc.) and Novartis guidelines, and to ensure supply of expert stability advice to customers, e.g. manufacturing and regulatory affairs.
Provides leadership, direction and support to the team members (direct and indirect) and ensures that they are adequately qualified and trained, achieve a high level of competence, are motivated and carry out their duties in a compliant manner.
Ensures that the team operates in a cost effective and efficient manner and maintains an innovative approach based implementation of best practices and harmonization of standards.
Ensures that performance review process for all team members is executed.
Performs integrated planning, priority setting and execution of activities fully synchronized with the business requirements.
Ensures timely preparation, review, approval and distribution of the following documents: stability protocols and reports (TechOps and TRD) evaluation reports of stability data in support of Annual Product Reviews, Product Quality Reviews, etc. Testing Monographs.
Ensures all documents comply with the current regulatory requirements, requests from Health Authorities, general guidelines (e.g. ICH, FDA, etc.) and Novartis guidelines (e.g. NovStyle templates, etc.)
Ensures stability reports include scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories Ensures adherence to the Change Control process in case of stability related changes. Ensures archiving of all documents according to the requirements of the current Novartis Records Management Program Performs Surveillance of Health Authority requirements, external stability guidelines, Novartis guidelines to ensure continuous compliance of the stability studies.
Ensures timely supply of quality expert advice to customers (e.g. manufacturing and regulatory affairs) on all stability related topics, such as deviations in product storage, transportation, etc. Supports preparation for external and internal inspections at Morris Plains according to the Novartis Pharma Corporate Quality Manual and answers questions during inspections.
Ensures implementation of associated corrective and preventive actions.
•Supports external inspections at customer sites on stability matters, related to assigned product responsibility.
•Supports implementation of associated corrective and preventive actions.
•Provides together with site management direction, formulates strategies and makes decisions, which ensure the efficient operation of the PharmOps business as a whole.
•Additional individual tasks/projects will be defined.
•Possesses Leadership experience and people management skills.
•Understands business needs and can provide strategic input.
•Work with biohazardous agents such as human cells, Lentiviral Vector, Human AB serum.
•Requires walking / standing for extended periods (up to 6 hours) throughout the work shift.
•May require dexterity for fine motor tasks such as pipetting and sterile manipulations in biosafety cabinets (periods up to 2 hours).
•May need to adapt to changing work shifts, both swing and/or graveyard on very short notice.
•May use a computer for greater than 4 hours a day.
| || 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. |