
Description
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 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.
- Must have experience implementing QMS
- Experience in product development and working within a regulated environment highly desirable.
- Must have previous leadership experience.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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