Senior Manager, Clinical Quality Assurance
- Posted: over a month ago
Title: Senior Manager, Clinical Quality Assurance
Location: Gaithersburg MD 20878 and Remote BUT needs to be drivable to office
Schedule: Standard business hours
Start date: Immediately
- Participates in oversight and management of Investigator Site Audits, Internal Audit and Clinical Vendors/CROs Quality Programs with guidance from management
- Works with internal and external GCP/PV entities and develop and execute strategic audit plans.
- Supports the development and/or review of GCP/PV audit agendas, audit plans, audit reports, and CAPA's for internal & external audits.
- Supports the development, implementation and maintenance of CQA systems and SOPs for GCP/PV systems
- Leads internal and external audits of the various quality elements to ensure compliance to GCP/PV/GCLP regulatory commitments and requirements, industry best practices and guidance
- Act as a contact with members of Regulatory Authorities and / or vendors; assist and lead inspections / audits, in agreement with QA management.
- Participates in company preparations for regulatory inspections, which may include reviewing Inspection Readiness Plans, Mock Inspections, and risk-based management of program inspection quality events.
- Evaluates and presents solutions on complex issues with minimal input from senior staff
- Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide assessment of the impact of any deficiencies.
- Reviews, tracks and/or trends routine quality data. Reports adverse trends to management with remediation plan.
- Performs final quality review/assessment for new Clinical Vendors/CROs
- Trains and mentors junior staff
- Independently writes and implements controlled documents (i.e., SOPs, Policies, Audit reports) which may entail significant system changes
- Stays current with changes to current GCP/PV/GCLP regulations, including FDA, EU, and other regulatory bodies (relevant to NVAX activities) and guidance bodies so that NVAX's compliance policies are current and effective.
- Bachelor's degree in biological science is required.
- 8+ years' experience in GXP pharmaceuticals, biologics and/or vaccine clinical research.
- 5+ years industry experience in an auditing role
- CQA/RAPS or other audit certification is highly preferred.
- Knowledgeable in principles and current GCP/PV/GCLP in a clinical development to commercial application setting.
- Excellent multi-tasking, analytical, organizational and teamwork skills.
- Ability to troubleshoot, identify root cause and systematically resolve problems.
- Ability to communicate clearly and effectively with all levels of the organization.
- Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.
- Individual must be willing to travel domestically and internationally (30-50%), as needed.
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