394805BR
Mar 20, 2024
USA
About the Role
The Manager, Quality Control is responsible for the day-to-day operations of the internal QC laboratories at the manufacturing or testing site. This includes testing is performed in alignment with all relevant quality standards, and ensuring appropriate Quality Control processes, policies, and standard operating procedures to achieve the company's objectives are met.
• Develops cooperative and strong working relationships with Manufacturing, Quality Assurance and MS&T to achieve company objectives.
• Ensures that any results generated by internal and external laboratories, are in compliance with GMP.
• Responsible for oversight of routine testing, testing results review and approval and generation of Certificate of Analysis, as required.
• Acts as a subject matter expert for applicable areas.
• Ensures that internal and external laboratories comply with cGMP standards.
• Reviews and approves qualification/validation and routine testing documentation.
• Maximize Quality and process improvements.
• Executed proper investigation into the root cause of product and/or process failures and assists in determining appropriate product disposition and/or process improvements.
• Develops cooperative and strong working relationships with Manufacturing, Quality Assurance and MS&T to achieve company objectives.
• Ensures that any results generated by internal and external laboratories, are in compliance with GMP.
• Responsible for oversight of routine testing, testing results review and approval and generation of Certificate of Analysis, as required.
• Acts as a subject matter expert for applicable areas.
• Ensures that internal and external laboratories comply with cGMP standards.
• Reviews and approves qualification/validation and routine testing documentation.
• Maximize Quality and process improvements.
• Executed proper investigation into the root cause of product and/or process failures and assists in determining appropriate product disposition and/or process improvements.
Diversity & Inclusion / EEO
We 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail [email protected] or call +1 (877)395-2339
- Sandoz: e-mail [email protected] or call: +1-609-422-4098
Role Requirements
• Bachelor’s Degree in Chemistry, Biology or related sciences with 8 years of experience in pharmaceutical industry or equivalent and 2 years of direct supervisory experience.
• Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, influencing, motivating, and consensus and team building.
• Strong critical thinking, deductive reasoning, and decision-making skills.
• Strong understanding of material sampling, analytical techniques, manufacturing operations, GMPs and the principles behind them.
• Understanding of laboratory equipment such as ddPCR, qPCR, UPLC/HPLC, ICP-MS, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, Cell based methods, Microbiology methods, etc.
• Strong ability to work independently and effectively, prioritizing and delivering on tight timelines.
• Approximately 10-15% travel required.
The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 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
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 [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
• Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, influencing, motivating, and consensus and team building.
• Strong critical thinking, deductive reasoning, and decision-making skills.
• Strong understanding of material sampling, analytical techniques, manufacturing operations, GMPs and the principles behind them.
• Understanding of laboratory equipment such as ddPCR, qPCR, UPLC/HPLC, ICP-MS, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, Cell based methods, Microbiology methods, etc.
• Strong ability to work independently and effectively, prioritizing and delivering on tight timelines.
• Approximately 10-15% travel required.
The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 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
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 [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Operations
QUALITY
USA
Durham, NC
Novartis Gene Therapies
Quality
Full Time
Regular
No
