Site Quality Assurance Head

Naperville, IL
Full Time
Quality Assurance
Senior Manager/Supervisor

Site Quality Assurance Head

Summary

The Site Quality Assurance Head has responsibility for leading the Quality Assurance team at the Naperville site. She/he will be responsible for leading all aspects of quality at the site and ensuring the effectiveness of the quality management system. 

The position will oversee Quality Assurance at the site, including the planning, organizing leading activities, and supervising responsible Quality assurance team members to ensure company activities meet applicable regulatory requirements (GLP, GCLP, GCP, GMP, ISO, CAP/CLIA), and internal quality standards. In addition, she/he will serve as a regulatory resource for supporting CellCarta project teams at the Naperville site.

Main Responsibilities

  • Direct the Quality Assurance Department, including staff under his/her responsibility to ensure that the company procedures and processes are in compliance with applicable regulatory and guidance (GLP, GCLP, GCP, GMP, ISO, CAP/CLIA).
  • Ensures that the Quality Management System (QMS) as defined in the Quality Manual is established in the Standard Operating Procedures (SOP) and processes, implemented, monitored, and maintained throughout business units.
  • Oversees all auditing activities, including internal, customer, and vendor audits, in accordance with the established audit schedule or equivalent.
  • Supports auditors in the conduct of audits.
  • Ensure the appropriate certification (e.g. CAP/CLIA accreditation, ISO, GLP, GMP) is obtained as needed for the study conduct requirements at the site.
  • Coordinates and Participate in Development, Implementation, and Enhancement of Quality Systems and associated procedures.
  • Ensures that noncompliance to QMS is effectively addressed; provides support to resolve issues with processes across business units.
  • Participates in development and delivery of internal training programs.
  • Provides GxP compliance, general QA support and guidance to personnel.
  • Assists Management in the preparation for regulatory agency inspections and sponsor specific inspections.
  • Review and evaluate investigations, findings and resolutions, change control, CAPAs, non-conformances, and audit observations.
  • Provide Corporate Quality Metrics, as needed.
  • Keeps up to date with current regulatory guidelines and regulations.
  • Involved in the recruitment and management of QA personnel.
  • Communicate compliance risks to senior management.

Education

  • Bachelor’s degree in a scientific discipline

Main Requirements

  • More than 5+ years relevant experience in pharmaceutical / clinical industry working in a regulated environment with direct QA responsibility.
  • Knowledge, understanding, and application of FDA US Code of Federal Regulations (CFR) in relation to Good Laboratory Practice (GLP) and/or CAP, CLIA, GCLP, GMP, ISO quality requirements.
  • Knowledge in Drug Development, Validation of Analytical Methods, Quality Assurance and Regulatory Compliance.
  • Various bioanalysis techniques (Mass Spectrometry, ELISA, Immunoassays, Clinical automation, Immune monitoring techniques including Flow Cytometry, etc.).
  • Demonstrate documentation management skills, ability to design and implement quality processes.
  • Strong commitment to the accomplishment of tasks, self-motivated, excellent organizational skills;

Additional Requirements

  • As needed, must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous diseases such as HIV, HCV, or CMV virus.
  • Employee is personally responsible for following Health and Safety guidelines/instructions.

All applicants are considered for all positions without regard to race, religion, color, sex, gender, sexual orientation, pregnancy, age, national origin, ancestry, physical or mental disability, medical condition, military or veteran status, genetic information, marital status, ethnicity, citizenship or immigration status or any other protected classification, in accordance with applicable federal, state, and local news. By completing this application you are seeking to join a team of hardworking professionals dedicated to consistently delivering outstanding service to our customers and contributing to the financial success of the organization, its clients, and its employees. Equal access to programs, services, and employment is available to all qualified persons.

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