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Senior Manager, Clinical Quality Assurance

System One
Potomac, MD
  • Posted: over a month ago
  • Full-Time
Job Description

Title: Senior Manager, Clinical Quality Assurance

Location: Gaithersburg MD 20878 and Remote BUT needs to be drivable to office

Schedule: Standard business hours

Type: Direct-Hire

Start date: Immediately

Responsibilities:

  • 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.

Requirements:

  • 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.


System One

Address

Potomac, MD
USA

Industry

Technology

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