Quality Compliance Director

QUALIFICATIONS:

  • Bachelor’s degree in Life Sciences (Chemistry, Microbiology, Biology, Engineering, Pharmacist or equivalent).
  • Minimum 10 years quality or laboratory experience.
  • Minimum Five (5) years of Quality leadership experience within ISO 13485/GMP/Quality Systems.
  • Proficient in Microsoft Office applications – Word, Excel, PowerPoint, Outlook.
  • Strong knowledge of basic chemistry and microbiological principles, including environmental monitoring is preferred.
  • Previous experience in reagent or cell culture media manufacturing strongly preferred.
  • Previous knowledge of cleanrooms, aseptic processing, and FDA-regulated environments
  • Strong knowledge of quality system requirements – CAPAs, NCRs, Custom Complaints.
  • Previous knowledge of process and equipment validation is preferred.
  • Broad experience developing Standard Operating Procedures in an ISO environment.
  • Experience in vendor management and scorecards preferred.
  • Experience managing controlled documents and working within a QMS.
  • Experience with managing customer audits and regulatory audits preferred.
  • Experience with environmental health and safety activities.
  • Exposure to USDOT Hazmat requirements.
  • Strong interpersonal & communication skills.
  • Strong analytical and problem-solving skills with experience in disciplined problem-solving methods.
  • Experience with SPC or statistical process analysis.

RESPONSIBILITIES:

The Quality & Compliance Manager is responsible for the following:

  • Manage the Biologos Quality System.
  • Manage internal and externa quality testing programs.
  • Manage Quality System audits, internal and external
  • Manage and document Quality activities according to SOPs.
  • Write, revise, review or approved Controlled Documents as required.
  • Manage environmental health and safety programs and compliance.
  • Ensure compliance with Biologos’ Quality System and to applicable local, state, and federal regulations and requirements.
  • Oversee and provide leadership of the Biologos Quality function and team
  • Ensure timely response to internal and external customers’ requests.
  • Represent Biologos in quality-driven discussions with costumer contacts.
  • Manage testing lab relationships and oversee preparation of Quality Control test samples.
  • Reviewing and recording all test data received from 3rd Party testing laboratories.
  • Reviewing all batch record documentation for accuracy and completeness.
  • Releasing approved finished product and producing the associated Certificate of Analysis.
  • Maintaining the Biologos Environmental Monitoring program.
  • Performing process validation, cleaning validation, and stability validations, as required.
  • Ensure the maintenance and updating finished product specifications.
  • Complete Non-Conformance investigations and implement associated CAPAs.
  • Drive continuous improvement through KPIs and data-driven analysis.
  • Other responsibilities as needed.

LOCATION: 2235 Cornell Ave., Montgomery, IL (Note- moving to new site Northeast of current site in next year; North of I88, West of I355)