Quality Systems Manager

We Improve Lives—that’s what drives us. It’s what makes us better, more innovative, more compelled to work harder. What we do is develop superior point-of-care rapid testing solutions for healthcare providers around the world; what we help create is healthier lives and communities.

Job Title:

Quality Systems Manager

Reports To:

Senior Director of QA/QC

Position Summary:

The Quality Systems Manager leads and supports the development and implementation of Chembio’s quality system and compliance programs.  In addition, this person will manage the compliance program, in collaboration with the Sr. Director QA/QC, which will assure all aspects of the site’s Quality System are in conformance with customer, international and domestic requirements.  

Duties & Responsibilities include but are not limited to:
  • Quality Management Systems: Manage Chembio’s Quality Management System (QMS), including the development, continuous improvement, and implementation of key quality system processes
  • This includes leading efforts to develop requirements, validate, implement and maintain the electronic Quality System Management (eQMS).
  • Assures compliance to Quality System policies and procedures to meet requirements with the applicable domestic and international regulations/standards.
  • Designs and implements effective quality processes including procedures, documentation systems, CAPA, complaints, tools, reporting metrics and implementing measurable improvements that are required to meet quality system standards and customer requirements.
  • Responsible for reviewing and presenting the state of the quality system to management on a routine basis.
  • Internal Audit Program: Responsible for developing and managing the internal audit program, in conjunction with Sr. Director QA/QC. This includes the entire internal audit process: developing and monitoring schedules, planning, execution, review and issuance of documented reports, tracking/trending results, determining adequacy of applicable corrective actions and routine reporting to management.
  • This will include the planning and implementation of FDA Mock audits and remediation activities.
  • Corrective Action and Preventive Action (CAPA) Program: Manages the CAPA program to implement corrective and preventative actions (CAPA) for actual nonconformities or potential nonconformities in product performance, manufacturing processes, quality systems, and / or employee safety. Verify effectiveness of actions taken. Work with department leaders to assure timeliness of response to assigned CAPAs within required target dates
  • Documentation Management: Manage document control processes and systems for GMP activities in compliance with internal procedures and policies as well as regulatory requirements. This includes the routing, review, approval, distribution and archival of new and revised controlled documents to support quality system requirements.
  • Assure controlled documents are periodically reviewed for relevance and accuracy, and that actual practices are reflected as defined in applicable procedures.
  • Establish and maintain records management system including secure storage, retrieval, retention and destruction.
  • Supplier Management: Regularly monitors related external audit results and supplier performance to identify potential high risk suppliers and implement necessary actions to mitigate compliance and product risk.
  • In collaboration with Human Resources and relevant departments, implement and assure an effective Quality System Training program for all related procedures/processes.
  • Provide direct and/or indirect compliance support during FDA and other regulatory compliance inspections. Leads or assists in the development and execution of remediation efforts resulting from compliance inspections, FDA Mock Audits, including formal responses and implementation follow up.
  • Assist departmental management in the execution/implementation of projects, as requested
Qualifications Required:

Education/Work Experience/Knowledge

  • B.S. Degree in a Scientific or Engineering discipline, and minimum of 3-5 years of experience in a GMP related field within a medical device, biotechnology, biologics, or pharmaceutical manufacturing facility. 
  • Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/820).
  • Strong knowledge of GMP, SOPs and quality systems
  • Excellent writing skills.
  • Works on multiple assignments in collaboration with various department owners.
  • Advanced Skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat.
  • Ability to communicate and work independently with scientific/technical personnel
  • Excellent interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Experience with FDA (or Notified Body) inspections

Preferred Skills/Qualifications:

  • Ability to quickly grasp technology, medical applications, and applicable regulations/standards
  • Ability to create and effectively communicate regulations/standards
  • Ability to positively influence groups across an organization to embrace a common philosophy
  • Ability to manage and execute on multiple, critical projects simultaneously
  • Strong ethics to escalate issues in the face of competing priorities
  • Ability to train and develop staff

Skills/Competencies:

  • Certified for Lead Auditor, Internal/External Audits preferred

Physical Requirements:

  • Up to 15% travel domestically and some international
COMPANY PERKS:

    Full benefit package including:

  • Medical/Dental/Vision
  • Paid Sick/Vacation/Holidays
  • 401(k) with company match
  • Company outings and much more
COMPANY PROFILE

Chembio Diagnostic Systems, Inc. is a public company serving the increasing global demand for rapid tests needed for the effective prevention and treatment of infectious diseases and other conditions.
Located minutes off the Long Island Expressway in Medford, NY, Chembio operates a research and manufacturing facility that is registered with the US FDA.

For immediate consideration, please send a resume and salary requirements to snorcott@chembio.com Chembio is an Equal Opportunity Employer.

For more information about Chembio Diagnostic Systems Inc., please visit our website at www.chembio.com