Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

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/approve/ qualify/ validate/ transfer quality control test methods.

• Ensure QC training curriculum designs and conduct training.

• Assure the implementation of appropriate corrective actions in response to observations from Quality/ RA and System audits and/or third-party assessments.

• May provide oversight of groups responsible for technical leadership and guidance for the successful completion of major laboratory projects. Collaborate significantly with Analytical Development and Technical Service groups throughout and external to the corporation.

• Implementation of new quality control procedures.

• Transfer and development of new methods.

• Identify deviations from QC methods and develops appropriate CAPA's.

• Recommend method improvements.

• Contribute substantially to the interpretation of results and subsequent impact to product/methods.

• Implementation and monitoring of personnel training related to new method.

• Represent QC as the prime technical contact for laboratory projects.

• Identify useful resources when applicable to meet laboratory objectives.

• Interact with senior external personnel on technical matters requiring coordination between sites.

• Work independently with minimal to no supervision and direction.

• Work in compliance with cGMP's.

• Practice safe work habits and adhere to Genzyme's safety procedures and guidelines.

HSE

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.

• The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations.

• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

• All area leaders are to complete required monthly Managerial Safety Visits (MSV).

About You

Basic Qualifications

• Bachelor's degree in Life Sciences discipline and 6 years of experience in cGMP lab environment, or master's degree in Life Sciences discipline and 4-year experience in CGMP lab Environment, and background in Analytical Method Development and Validation.

• Experience leading technical groups focused on Analytical Development.

• Experience managing scientific projects and personnel and presenting technical data.

• Knowledge of CGMP, ICH, USP, and global compendial regulations and guidance's, particularly as related to analytical and bioanalytical method development and validation.

•  Experience with Scientific technical writing including authoring and revising SOPs or technical reports.

• Experience troubleshooting assay and equipment issues.

• Experience managing in a Quality Control environment preferred.

• Strong leadership skills, driving accountability, compliance, and efficiency.

• Strong working knowledge of laboratory information management systems (LIMS).

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.