Quality Compliance Director
- 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.
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)