Available locations: Pittsburgh, PA; or Duluth, GA.
Responsible for managing and overseeing the Quality and Compliance for the global Genomics Laboratories. This person is the leader responsible for the Quality Assurance and Compliance function of the Laboratories, ensuring compliance to applicable regulations; Service Laboratories (CLIA/ CAP/ ISO, State level licenses). Reporting to this role are the Quality leads at each of our clients’ Genomics Laboratories locations (Pittsburgh, PA; Branford, CT; Chengdu, China; Taicang, China; Chennai, India; Kuala Lumpur, Malaysia and Sollentuna, Sweden).
This position reports to the VP and Chief Scientific Officer of Genomics. This position is based out of Pittsburgh.
Its main goal is to partner with Senior Management to maintain the quality management system components necessary to successfully maintain the Genomics laboratory services in good compliance standing.
- Manage, mentor and coach regulatory and service lab staff on CLIA, CAP, NYSDOH, ISO regulations for laboratories.
- Coordinate and lead corporate compliance as applicable to the laboratories
- Work with operation leadership to manage and provide vision and leadership to the quality organizations at all of the lab services locations.
- Serve as Data Protection Officer (DPO) ensuring compliance with GDPR and similar data and client privacy regulations.
- Provide and facilitate communication between the lab services quality organization and cross-functional teams to ensure quality and compliance objectives are met.
- Establish and drive quality initiatives for all lab services organizations and where possible create consistent practices among all labs.
- Manage routine QMR process, and support Diagnostics BE QMR process
- In conjunction with the Diagnostics BE Regulatory department, work to facilitate domestic and international regulatory requirements
- Work with sites to prepare for and participate in inspections and audits.
- Set quality objectives and metrics for labs and assist with achieving goals.
- Monitor emerging regulations or market expansion regulations that affect lab functions and work with sites to remain / gain compliance with those regulations.
- Collect and analyze data required by regulatory agencies and by internal requirements.
- Ensure each site has an effective training program and maintains compliance with regulations
- Perform internal audits of lab services sites as well as customer audits as necessary.
- Ensure sites maintain and perform to an internal audit schedule and assist with corrective actions as necessary.
- Respond to and maintain oversight of audit finding remediation
- As needed, apply continuous improvement principles for system optimization
- Monitor performance and progress against documented objectives
- Authorization to work in the US for any employer without requiring further sponsorship.
- Masters or Bachelor’s degree in Biological Sciences or related disciplines
- Minimum of eight years of clinical laboratory quality and compliance experience with an understanding of laboratory techniques such as DNA Sequencing in a commercial, academic, or government laboratory.
- Certified in one or more quality-related disciplines, e.g., ASCP
- Detail oriented, highly organized, with excellent verbal and written communication skills.
- Ability to work independently under pressure of deadlines and a fast paced, high throughput team environment.
- Strong project management skills related to submission of validation documentation
- Excellent interpersonal skills and ability to work collaboratively with individuals at all levels of the organization.
- Experience leading and managing a diverse team of individuals with a proven track record of successful outcomes.
- Acts with honesty, integrity and a strong code of ethics at all times.
Women and Minorities are encouraged to apply.
Diversity is foundational to PerkinElmer and we know that hiring talent with different backgrounds will provide a greater impact for our customers and a more inclusive workplace for our team. Our commitment to creating a culturally diverse workplace is REAL! We know that it’s the people that make PerkinElmer a wonderful, enriching place to work that is why we are always searching for talented and motivated individuals to join the PerkinElmer Family.
So what’s in it for you?
We create a customized development plan to help you achieve your career goals. We partner with you to build a long and rewarding career by providing:
- On-the-job training
- Mentoring relationships
- Ongoing career development planning
- Company and external training programs
- Opportunities for internal career mobility
Our company fosters innovation, knowledge sharing, and teamwork for long-term success. We are committed to the development of your career, giving you opportunities to learn and grow. Simply put, we make a difference for you, so you can make a difference in the world.
We are passionate about our work and the benefits we create for our customers, our communities, and our environment. Every day, we help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
With about 13,000 employees worldwide, we pioneer scientific technologies for food and drug safety, environmental monitoring, industrial analysis, screening and diagnostic testing, and imaging for life sciences. We provide better detection, imaging, and informatics to help our customers make a profound impact on the world.