Novartis Hiring for Manager, Quality Control Operations job in Millburn Full Time

About the role
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Quality Control professionals to help us reach our ambitious goals.

The Quality Control Operations Manager will be responsible for ensuring that day-to-day QC laboratory operation is performed in a manner that is compliant with GMP/FDA regulations and Novartis SOP’s. Due to the nature of the process (radioactive) this role requires basic proficiency, ownership of the quality control techniques, and understanding of radiation safety standards.

Main responsibilities:

• Oversees day-to-day operation of Quality Control laboratory and develop the skills of their team for career growth, keeps up with industry trends and best practices and drives spirit of continuous improvement to ensure Inspection readiness state.
• Manages Quality Control Key Performance indicators (KPIs) (timeliness, training, testing cycle time, periodic review, etc.), oversees stability testing program at Millburn facility and collaborates with Global organization to resolve any analytical testing problems, recommend appropriate changes, if required.
• Ensures quality control events are categorized and escalated timely and conducts or delegate laboratory investigations, including OOS/OOT/OOEs and deviations. Ownership and/or oversights of laboratory based corrective and preventive actions (CAPA) implementation.
• Writes, reviews, and approves documents needed for laboratory operation, such as Standard Operating Procedures (SOP’s), methods, specifications, change control requests, method and equipment validation activities, etc.
• Supports their team for all technical aspects related to quality control testing readiness, including Quality Control (QC) reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management, and QC testing.
• Acts as Subject Matter Expert in his or her area of expertise: primary contact for troubleshooting, deviation/OOS investigations, assesses product and environmental data and performs trending, and QC documentation management.
• Selects, trains, supports laboratory personnel in the performance of the testing procedures required to meet regulatory and scientific standards for pharmaceutical products.
• Acts as designee and make key decisions regarding quality control processes in the absence of the QC Head, facilitates a culture of “speaking up”, ensures all compliance activities are followed and supports regulatory inspections and audits.

Note: Work schedule: Wednesday-Saturday
12Noon-10PM

Commitment to Diversity & Inclusion:
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:

• Novartis: e-mail [email protected] or call +1 (877)395-2339
• Sandoz: e-mail [email protected] or call: +1-609-422-4098

Role Requirements
What you’ll bring to the role:

Education: Bachelors’ degree in Life Sciences for example Chemistry OR Microbiology

Experience:

Minimum of 5-7 years’ experience in Quality Control in Good Manufacturing Practice (cGMP) or aseptic environment required.
• Knowledge of cGMP regulations and FDA guidance applicable to Quality Operations for Quality Control for product and Environmental Monitoring testing, Aseptic techniques, Analytical equipment

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

The pay range for this position at commencement of employment is expected to be between $102,400 and $153,600 per year; 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.

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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network