342029BR
Jun 15, 2022
USA

Job Description

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

The Manager, Quality Control Operation will be responsible for ensuring that day-to day QC laboratory operation is performed in a manner that is compliant with GMP/FDA regulations, AAA and Novartis standard operating procedures.

Your responsibilities include, but are not limited to:

• Lead and Oversee day-to-day operation of QC laboratory
• Provide leadership, direction, and support to the people within the Quality Control
• Keep up with industry trends and best practices. Drive spirit of continuous improvement to ensure Inspection readiness state.
• Manage QC KPIs (timeliness, training, testing cycle time, periodic review, etc.)
• Oversee stability testing program at Millburn facility
• Collaborate with Global organization to resolve any analytical testing problems, recommend appropriate changes, if required.
• Ensure QC events are categorized and escalated timely
• Conduct or delegate laboratory investigations, including OOS/OOT/OOEs, and deviations
• Writing, review and approval of documents needed for laboratory operation, such as SOP’s, methods, specifications, change control requests, etc.
• Drive all technical aspects related to quality control testing readiness including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing
• Act as Subject Matter Expert in his or her area of expertise: primary contact for troubleshooting, deviation/OOS investigations, assess product and environmental data and performs trending, and QC documentation management
• Select, train, supervise laboratory personnel in the performance of the testing procedures required to meet regulatory and scientific standards for pharmaceutical products. Staff performance management and development
• Act as designee “deputy” and make key decisions regarding quality control processes in the absence of the QC Head
• Ensure the implementation, ongoing monitoring and reporting of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) that drive continual improvement QC organization.
• Ensure that QC testing is properly conducted and documented for all performed activities, with emphasis on Data Integrity. Evaluate and approve QC records as required.
• Facilitates a culture of “speaking up” and ensuring all cGMP compliance activities are followed
• Support regulatory inspections and audits
• Participate in proving input to the preparation of the QC budget of the Quality Unit
• Ensure health & safety procedures are followed

https://www.youtube.com/watch?v=4A1joFLTfo0

Diversity & Inclusion / EEO

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.

Minimum Requirements

SHIFT: Sunday-Wednesday 1st Shift

What you'll bring to the role:

Bachelor’s degree in relevant Analytical testing/Microbiology discipline.

Experience / Professional requirements:

8-10 years experience in Quality Control in cGMP or aseptic environment required. Minimum of 2 years of Supervisory experience.

• Good Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, Aseptic techniques, Analytical equipment.
• Applied knowledge and experience in analytical tools and testing strategies used in the development/QC laboratory as it relates to Aseptic manufacturing (e.g. HPLC/UPLC, spectroscopy, mass spectrometry, sterility testing, environmental monitoring programs) at site and global level
• Demonstrated knowledge and experience with cGMP requirements
• Experience in process improvement approaches (Lean Six Sigma, Total Quality Management, 5S, etc.)

* Practical experience in Analytical Chemistry and Microbiology techniques.


Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. 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 [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
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
Millburn, NJ
Quality
Full Time
Regular
No
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342029BR

Manager, Quality Control Operation

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