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Job Details


Novartis

Manager, Quality Control Operations

Pharmaceuticals

All

Full Time

On Site

No

Millburn, New Jersey, United States

About the Role

Location: Millburn, NJ

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