NJ Employer QA Deviation Manager in Morris Plains, New Jersey
Job ID 236372BR Posting Title QA Deviation Manager Division Novartis Technical Operations Business Unit NTO BTDM Country USA Work Location Morris Plains Company/Legal Entity Novartis Pharmaceuticals Functional Area Quality Job Type Full Time Employment Type Regular Job Description This position will be expected to work a M-F work shift. (some work may be required in the evenings and weekends) *Lead in developing, structuring, organizing and managing a team of QA Deviation Specialists to support 7 days a week manufacturing operation. *Works with QA Operation Batch Managers, Specialists and Associates to meet batch record review/disposition schedule in order to adhere to infusion schedule dates. *Ensure the deviation process meets Industry and Novartis expectations and requirements. Drives continuous improvement and enhancement efforts with regards to the management of Deviations to ensure an efficient yet Compliant process is maintained *Initiates, Reviews and Approves Deviations, CAPAs, Quality Events to ensure adequate levels of documentation are adequate and compliant to existing procedures. Provides appropriate feedback as required. *Coordinates activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish meeting minutes and action items from meetings; provide support to the investigation process and follow-up to ensure timely deviation closure. *Initiates Escalation activities as required. Participate in escalation meetings as required. Communicates all pertinent information to QA Operations team related to escalation activities. *Performs independent quality evaluation of investigational reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending. *Develops meaningful site KPI's and prepares and presents trend reports for Quality Management Reviews. EEO Statement Minimum requirements EducationBS/BA in Biological Sciences or equivalent relevant career experience Fluent in English written and verbalExperienceMinimum of 10 years GMP manufacturing and/or QA related experience, at least 5 years of which are in the area of quality assurance and/or compliance or equivalent experience. *Experience in working in Analytical Development and/or Quality Control functions. *Strong planning, execution, interpersonal, communication, negotiation and problem solving skills *Strong project management skills *Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teamsThe 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.