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GMP Training Manager

Ridgefield, New Jersey

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our manufacturing and production facilities are seeking a successful candidate to help ensure production units are running smoothly, required materials are available in a timely manner, and procedures are in line with regulations. The candidate should also have a familiarity with reading/writing SOP's with and batch records and coordinating activities with related groups(Quality, Validation, Metrology, and Facilities). The candidate will participate in clinical manufacturing under cGMP regulations which include; sampling, analyzing, documenting, witnessing production events, and equipment reprocessing. The successful candidate should have the ability to operate complex systems and equipment using batch records and SOPs in accordance with current GMPs and safety guidelines under limited supervision. Weekend work may be required for some on a rotating basis.

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Rewards

  • HEALTH AND WELLNESS PROGRAMS

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • EMPLOYER MATCHING

    Employer matching because Sanofi invests in their employees!

  • PROFESSIONAL DEVELOPMENT

    Sanofi is eager to further your development and expertise in an ever challenging environment.

  • FAMILY SUPPORT

    Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.

  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

  • WORK/LIFE BALANCE

    Importance of life outside of the office is valued at Sanofi.

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Responsibilities

Department

The Training department is dedicated to the continuous improvement of employee skills, ensuring all employees are well prepared and qualified to perform their job.  The Training group designs, develops, implements and facilitates CGMP training along with ensuring compliance with applicable regulations through appropriate documentation, qualified trainers, and approved training content. We provide programs, services and systems designed to assist people with managing their learning at work.

Training Manager

The Training Manager is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for managing the GMP training program and to;

  • Develop and deliver training using novel and traditional techniques to ensure are engaged and learned in their role.
  • Track and monitor metrics related to individual and departmental trainings and reacting to those metrics to ensure compliance with the training program.
  • Manage and administer training through the validated learning management system in use at the site.
  • Identify training needs and opportunities for all employees across all levels.
  • Implement the “WHYS” into site specific training and procedures to ensure employees understand their role and the rationale behind performing specific tasks.
  • Assist with internal and external audit as required.
  • Ensure effective and timely investigations are performed as well as appropriate CAPA’s implemented to prevent reoccurrence.
  • Provide direction and guidance to direct reports to ensure a compliant and effective organization.
  • Develop and implement special projects as the need arises. 
  • Continually assess the health of the Training Department in an effort to ensure continuing compliance, and streamline the department with a focus on efficiencies.
  • Establish and deliver on site strategic as well as departmental training goals.
  • Ensure compliance to the applicable corporate guidances, standards and policies.
  • Develop a network and continually benchmark against similar training programs both internally and externally.
  • Identify best practices through-out the training industry and seek to embellish the Ridgefield site training program by leveraging from these.

Leadership Qualifications:

The Training Manager is expected to act on and demonstrate the Sanofi LEAD competencies:

  • Act for Change: Embrace change and innovation and initiate new and improved ways of working. 
  • Cooperate transversally: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results. 
  • Develop People: Take responsibility for developing one’s self and others in anticipation of future business needs. 

Basic Qualifications

  • Bachelor’s degree and 5 years of experience in learning & development with 8 years of experience in a GMP regulated environment.
  • 5 years of experience performing work that requires decision making and the consistent exercise of independent judgment and discretion.
  • 5 years of experience exercising considerable discretion in determining objectives of and approaches to significant organizational projects or assignments.
  • 5 years of experience developing and delivering training programs.
  • 5 years of experience with Learning Management System.

Preferred Qualifications

  • Bachelor’s level degree in life science, instructional design or related field preferred.
  • Strong content knowledge in CGMP/regulatory compliance.
  • Manufacturing and/or Quality experience, preferably both.

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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#LI-GZ

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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