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QA Operations Manager
Location:
Polis
Description:
Job Description Summary The QA Operations Manager is responsible for quality assurance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures and quality systems. Provide Leadership and manage Quality Assurance Managers in all quality related matters and to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual and Policies. Ensure that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Novartis Quality Standards. Job Description Provide shop floor oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents. Ensure the Quality Operations team is fully staffed to support operations within supply chain, technical operations and the laboratories across all scheduled shifts. Hire and supervise internal and external staff. Provide daily leadership and management for the QA Operations Team. Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately. Assist functional areas with achieving timely and compliant final product disposition of the product. Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections. Review, approve and support procedures investigations, corrective and preventive actions, change controls, complaints, training and production/testing records as required. Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity. Establish site Sterility Assurance program, implement governance to ensure compliance of site personnel and application of aseptic techniques, Site Microbiological control strategy and trending (EM and Product) and full compliance to sterile manufacturing regulations. Other related duties as assigned. Minimum requirements: Bachelor's Degree, preferably in Life Sciences, Chemistry or related relevant degree. 5+ years of experience in a GxP manufacturing operations environment. 2+ years of experience in aseptic GMP manufacturing is preferred. 2+ years of experience in a quality assurance role is required. Excellent communication skills Previous leadership experience is preferred. The base pay amount for this position at commencement of employment may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the -most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/careers/benefits-rewards Novartis. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/en_US/network. 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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to XXXX@novartis.com call +1 (877)395-XXXX and let us know the nature of your request and your contact information. Please include the job requisition number in your message. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings Salary Range $112,800.00 - $169,200.00 Skills Desired Continuous Learning, Employee Performance Evaluations, Gmp Procedures, Managing Ambiguity, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technical Knowledge, Technological Intelligence
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More About this Listing: QA Operations Manager
QA Operations Manager is a Executive Operations Manager, QA Job at Novartis located in United States. Find other listings like QA Operations Manager by searching Oodle for Executive Operations Manager, QA Jobs.
QA Operations Manager is a Executive Operations Manager, QA Job at Novartis located in United States. Find other listings like QA Operations Manager by searching Oodle for Executive Operations Manager, QA Jobs.