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Senior Manager of Quality Assurance

Kelly Science, Engineering, Technology & Telecom
Livingston, NJ Full Time
POSTED ON 3/10/2025
AVAILABLE BEFORE 6/8/2025

Kelly Science is seeking a Senior Manager of Quality Assurance for a growing company located in Livingston, NJ.

Salary : $160,000-170,000 / year 15% annual bonus

Employment Type : Full Time; Direct Hire

Summary :

As the Senior Manager of Quality Assurance, you will be responsible for all aspects of Quality Assurance including but not limited to : compliance with applicable regulations and standards, assist in post market surveillance activities and continuously monitoring the organization identifying opportunities for improvement and alignment.

Job Responsibilities :

  • Responsible for day-to-day oversight of the quality management system including quality events including deviations, nonconformances, change control, CAPAS, complaint handling, monitoring, and resolution, supplier quality, document control, and records management.
  • Identify areas for improvement in validation and compliance processes and implementing corrective actions.
  • Develop, implement, maintain and continually assess the company's QC function and QMS for applicable regulated activities to meet internal company standards and internal global regulatory requirements.
  • Designing and implementing training programs for quality assurance team members on validation and compliance procedures, and to ensure the understanding of the QMS.
  • Responsible for ensuring that all manufacturing equipment, processes, and documentation meet regulatory standards and demonstrate suitability.
  • Lead and participate in cross-departmental / organizational teams. Accountable for quality control support of new product integration, stability program, process development, equipment and process validations, as well as meeting production schedules.
  • Establish and implement consistent metrics for monitoring system effectiveness to enable Quality customers to make sound quality decisions and drive continuous improvement.
  • Lead and coach individuals within the Quality Team. Conduct ongoing performance acceleration / evaluation assessment and provide feedback to employees in order to help optimize their and the teams overall performance
  • Mentor the team and actively identifies professional development opportunities.

Qualifications :

  • Bachelor's degree in scientific field required.
  • 5-7 years of relevant industry experience. Must have a background in genomics / Next Generation Sequencing.
  • Experience in product development and working within a regulated environment highly desirable.
  • Must have previous leadership experience.
  • Salary : $160,000 - $170,000

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