Manager, Quality Control

Job Title: Manager, Quality Control

Location: Ridgefield, NJ

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Manager Quality Control is responsible for technical management of personnel involved in the development, transfer, and troubleshooting of routine and complex techniques associated with daily QC release and provides an in-depth investigative and technological orientation in implementing, executing and interpreting quality procedures and test methods. The manager Quality Control will substantially contribute to overall process and method improvements within the Quality Control laboratory.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Management of activities within the Quality Control Chemistry Laboratory, specifically focused on personnel management and development, and the technical and compliance aspects of methods and techniques including:

Staff Management:

• Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.

• Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.

• Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.

• Develop work plans, assign tasks, and supervise team(s).

• Ensure staff has appropriate knowledge of department processes and procedures.

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Budget:

• Provide input into the department budget.

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Department Management:

• Maintain and report applicable department or organizational metrics.

• Accountable for project completions and achievement of compliance goals.

• Represent department in Project Team meetings.

• Interact with Project Teams and cross-functional groups as they impact the quality operation.

• Address and/or escalate CQO compliance problems and issues.

• Investigate and troubleshoot Quality Control methods.

• Review QC Data for compliance to procedures and specifications Statistical analysis of results.

• Oversight of investigations related to OOS/OOT results.

• Oversight of transfer of methods from support groups to the QC laboratory.

• Develop and author complex and explicit documentation for new and current procedures and technical reports.

• Oversight of implementation of new technologies/instrumentation in the QC laboratory.

• Technical guidance and resource in the QC laboratory.

• Oversee management of reliable analytical testing and timely reporting of intermediates, final product, and stability samples and monitor for Out of specification (OOS) and Out of tolerance (OOT), to ensure effective, thorough, and timely laboratory investigations.

• Oversee proper assay performance through data trending and metrics, immediate, effective response to laboratory errors and deviations and investigations.

• Ensure strong Quality program for management of equipment and computer systems to ensure proper maintenance, calibration, and conformance to regulatory standards.

• Maintain procedures for accuracy and compliance.

• Draft/revise/review/appro