Senior Manager of Quality Systems (Genomics)

Kelly Science is seeking a Senior Manager of Quality Systems (Genomics) 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 Systems (Genomics), 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 implementing a QMS
• Experience in product development and working within a regulated environment highly desirable.
• Must have previous leadership experience.