Investigations Manager, AS&T

Job Description PURPOSE In this role, the Investigations Manager, AS&T will lead a team of investigators to support QC laboratory and manufacturing operation through timely, efficient, and effective deviation and OOS management. RESPONSIBILITIES o  This position will be expected to work Monday through Friday, though support may be needed evenings and weekends. o  Lead in the organization and management of a team of Quality investigators for assay-related issues and manages solutions o  Leads the team and coordinates with all necessary stakeholders to meet disposition schedules so patient infusion dates are upheld o  Ensures the deviation process meets industry and company standards o  Drives continuous improvement and enhancement efforts to ensure both a compliant and efficient process is maintained o  Initiates, evaluates, and approves deviations, OOS, CAPA, and quality events to ensure adequate levels of documentation o  Coordinates CAPA activities and ensures effectiveness o  Supports escalation activities o  Evaluates events for appropriate root cause analysis o  Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Envi-ronmental Protection regulations. o  Assists with Human Error Reduction Program o  Drive CTL019 Final Product Release Documentation o  Knowledge and familiarity of SAP systems, including Quality Module (QM). o  Knowledge and familiarity of LIMS systems (Labware LIMS) o  Knowledge and familiarity of eSOPS and TEDI. o  Ensure conformance to in-house specifications and GMPs o  Attend all appropriate company, departmental, and/or group meetings to ensure seamless communication of information o  Performs training of new associates o  Assist in troubleshooting problems on lab instruments and analytical methods o  Authors new and revises existing cGMP documents to ensure compliance Project Management o  Leads, manages and tracks progress of projects as required o  Identifies needs for training courses and development of new skills. o  Supports recruiting activities by participating in interviews and provides candidate assessment in addition to basic activities. Compliance o  Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations. Other o  Actively develops employees and builds talent pipeline. EEO Statement 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. Minimum requirements Education: BS in biology, chemistry, biochemistry, microbiology or other related science. Prefer MS in a life science discipline. Experience: o  Minimum: 8-10 years of experience. o  Experience in Quality Control or Quality Assurance in a biologics or cell therapy environment. o  Expertise in ICH and FDA/EMEA GMP requirements o  Ability to plan, prioritize and execute multiple tasks simultaneously under tight deadlines o  Ability to manage projects and lead teams utilizing mod-ern project management methodology and tools. o  Knowledge of statistical tools and methods o  Strong verbal and written technical communication skills o  Strong interpersonal skill o  Proficiency using MS Word, Excel, and MS project o  Knowledge of cGMP, USP and FDA guidelines. o  Thorough knowledge of bioassay test methods. o  Knowledge of LIMS systems. o  Knowledge of Change Control systems, such as Agile PLM o  Knowledge of Quality Management Systems, such as Trackwise o  Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations. o  Detail-oriented with expertise in problem solving and solid decision making abilities. Job ID 251314BR
Salary Range: NA
Minimum Qualification
8 - 10 years

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