TITLE: Quality Assurance Manager
REPORTING TO: Director, Global Regulatory Affairs for Research
LOCATION: Center for Biomedical Research (CBR), New York, NY
JOBS SUPERVISED: NA
ASSIGNMENT LENGTH: One year, renewable by mutual consent and/or availability of funding
POSITION SUMMARY: The Population Council’s Quality Assurance Manager (QAM) position is responsible for Quality Assurance activities across the Council’s Research and Development (R&D) programs. The QAM assures GxP compliance through maintenance of the Council quality system, training of staff on the quality system, conduct of internal and external audits, and investigation of system discrepancies (deviation/CAPA management). The QAM maintains the GxP lifecycle for all Population Council clinical trial materials including control of starting materials, drug substance/drug product manufacturing (GMP), product release documentation (GMP/GCP), preclinical testing (GLP and non-GLP), and coordination of stability testing and reporting (GMP).
1. Communicate GMP, GCP and GLP standards to project teams to ensure fit for purpose clinical trial material preparation, new drug application(s), and product licensure studies.
2. Train laboratory and clinical staff on all aspects of GxP compliance:
a) Population Council Policies and SOPs,
b) Data management across laboratories and clinical operations (good documentation practices, data integrity, discrepancy reporting),
c) Relevant FDA statutes and guidance (US standards), and
d) ICH guidances (international standards).
3. Maintain GxP Lifecycle for all Population Council manufactured materials:
a) Establish maintain incoming material specifications and related documentation,
b) Review and approve master batch production records and executed batch production records,
c) Assemble batch release documentation for approval by Director, Global Regulatory Affairs for Research,
d) Manage GLP compliance for all preclinical testing including prequalification audits, and protocol-report archival, and
e) Coordinate and manage GMP compliance the Population Council stability programs including sample management, protocol issuance, reporting, narratives for health authority communications (Module 3 of annual reports, INDs, NDA-BLAs etc).
4. Manage Deviation and Corrective and Preventative Action (CAPA) system:
a) Track Deviations and CAPAs events from initiation to closure,
b) Coordinate quarterly management Deviation/CAPA review meetings, and
c) Ensure continual organizational improvement based on the Deviation/CAPA system.
5. Manage GxP audit program:
a) Conduct internal audits of in-house GMP facility,
b) Conduct qualification audits of external GMP facilities,
c) Conduct internal audits of in house GCP activities,
d) Conduct qualification audits of external GCP facilities,
e) Qualify and monitor analytical testing laboratories (GLP, GCLP and equivalent)
f) Participate in inspections for CBR facilities by government agencies (e.g. Drug Enforcement Agency, NY State), and
g) Coordinate audit CAPA program and ensure all audits are formally closed out when CAPA plan is complete.