Manager, GMP Manufacturing Support

Major accountabilities:

• Participates in internal and external strategy and planning meetings, surveys, new business presentations, mobilization, and support activities related to the Critical Environment Cleaning Program.
• First line of contact to all facilities cleaning, GMP & Non- GMP cleaning.
• Serve as back-up finite scheduler.
• Ensure site cleaning and gowning programs in compliance with Novartis Standards to maintain site in compliant state for GMP manufacturing of gene therapy products.
• Develops and maintains compliant housekeeping program to ensure GMP manufacturing and testing facility is in compliant inspection ready state. Programs to include routine walkthrough of GMP warehouse, manufacturing, and test labs, to identify, track and resolve housekeeping deficiencies.
• Manages inventory levels for both cleaning and gowning materials as well as supplier contracts or service contracts associated.
• Writes performance reviews and annual goals, holds one-on-ones, and handle HR related matters Implement, train, and educate staff on the on-going efficient delivery, operation, and maintenance of the cleaning program.

Minimum Requirements:

• High School diploma/GED and 12 years of Supply Chain and/or Operations experience biopharmaceutical industry ; OR Associate’s degree and 10 years of Supply Chain and/or Operations experience in biopharmaceutical industry ; OR Bachelor’s degree in biochemistry, chemical engineering, bioengineering or supply chain, operations or related technical field and 8+ years of experience in biopharmaceutical industry ; OR Master’s degree and 6 years of Supply Chain and/or Operations experience in biopharmaceutical industry ; OR Doctorate degree and 2 years of Supply Chain and/or Operations in biopharmaceutical industry

• Solid knowledge of FDA regulations and GMP systems.
• Excellent oral and written communication skills.
• Demonstrated leadership skills.
• Experience managing contract employees or service providers in GMP environment.
• Experience and working knowledge of GxP, and ISO safety cleaning standards.
• The ability to read, comprehend, and transmit complicated detailed instructions in writing and orally required.
• Knowledge of the Business and Industry marketplace, current Good Manufacturing Practice (cGMP) and other critical environment cleaning practices and procedures, applicable laws, health, safety and environmental practices, principles of management and supervision, and department procedures and policies.

The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 annual; however, base pay offered 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/about/strategy/people-and-culture