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Job ID :
44040BR
Location :
US - New Jersey - Fair Lawn
:
Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

The Sr. Manager – Quality and Compliance Improvement role is responsible for the identifying, leading, and managing small, medium, and large projects to correct quality and compliance problems; implement improvements in quality and compliance; and assure continued compliance with evolving quality and compliance requirements.

Primary Responsibilities
  • Understands requirements and processes for Best in Class Quality Management Systems
  • Leads large cross functional and complex initiatives to identify, develop, modify, improve, and implement global process solutions for compliant Quality Systems.
  • Oversee all aspects of project scope, schedule, resource risks and overall management to ensure and drive successful delivery.
  • Ensure deliverables/milestones in project plans are achieved within cost, schedule, scope, quality and delivery
  • Assists in development of policies and procedures supporting Quality Systems
  • Develops and delivers training curriculum and content for Quality Systems processes
  • Through the analysis of Quality and Compliance processes, and understanding of industry best practice, collect and translate Quality insights, ideas and concepts into clearly defined requirements for process improvements
  • Demonstrates enthusiasm, takes accountability and drives for results
Secondary Responsibilities
  • Ensure that solutions implemented are scalable, flexible and consistent in all regions whenever possible.
  • Coordinate with global counterparts to determine and communicate global impact of proposed changes.
  • Participates in industry and other professional networks to ensure awareness of industry standards, trends and best practices in order to strengthen Quality Systems knowledge.


Qualifications
  • Bachelors Degree in Engineering, Science, or related field
  • Must have a minimum of 7 years experience in a Quality Systems role with significant experience in Project Management supporting Quality and Compliance and the successful completion of various process and solution implementation projects varying in size and complexity, including large and global projects.
  • Expertise in ISO 9001 and/or ISO 13485, and GMP requirements
  • Experience in Operations a plus
  • PMP Certification preferred
  • This position may require approximately 25% travel. The travel may be both domestic and international.
Job Skills
  • Strong expertise and practical experience with Project Management concepts, processes, skills, and tools
  • Ability to lead large, complex projects for the investigation and identification and retooling of process and systems solutions, and the development and deployment of these solutions to enable best in class Quality Systems. Projects will be multi-site and multifunctional in scope.
  • Proven ability to lead groups, manage project deliverables, and maintain client relationships
  • Experience in managing budget, project plans, resource allocations and priorities
  • Demonstrates significant knowledge and work experience in relevant Quality Systems functional areas, processes, and best practices, including CAPA management, Complaint Handling, Document Control, Change Control, QRB
  • Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below; ability to prepare high quality presentations and deliver them effectively
  • Ability to execute training needs analysis, prepare curriculum and deliver functional and advanced training.
  • Ability to enable cultural transformations; act as a role model; and manage change
  • Exceptional interpersonal skills, including teamwork, facilitation, and negotiation
  • Ability to make decisions in the face of uncertainty and complex situations
Job Knowledge
  • In-depth industry related knowledge – Quality Systems best practices and policies
  • Expert knowledge in compliance with quality standards (i.e., GMP, ISO regulations)
  • Understanding of business processes – Quality Systems
  • Seen as subject matter expert when determining clarifications and compliance to written standards, providing additional information, guidance, and training to ensure consistent application of quality processes
  • Conducts advanced data analyses to identify complex quality problems and identify larger scale quality improvements. Implements quality improvements independently based on analysis
  • Six Sigma and/or Lean training a plus.
Additional Job Abilities
  • Requires the ability to perform independently and/or as part of a team and to lead large complex projects with a global scale
  • Exercises leadership, initiative, and self-sufficiency while keeping management and stakeholders appropriately involved and informed.
  • Ability to solve complex and broad-scoped problems and deal with a variety of variables in unique situations.
  • Instill customer satisfaction that is recognizable and valuable to the customer.
  • Able to work independently without significant direction, exercising leadership and self-sufficiency while keeping management and stakeholders appropriately involved and informed
  • Works effectively in a virtual team environment.
  • Exceptional interpersonal and communication skills (includes verbal, written, and presentation) to be able to liaise with colleagues, management, chief executives, and other senior people inside and outside the organization on a regular basis.
  • Produces polished, original, formal presentations for all sizes of audiences including large audiences

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

*IND-LPG

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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