(Sr) Manager, Clinical Quality Assurance Compliance

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
  3. United States
Seattle, USA
Posting date: 10 Feb 2021

Proclinical is working with a leading biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Our client is urgently searching for a Remote (Senior) Manager of Clinical Quality Assurance Compliance to join the Clinical Quality Assurance (CQA) group. The qualified individual should have experience with US and international GCP/PV/GCLP regulations, guidance documents, and industry best practice in all areas of a GxP environment.

Job 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 guidances
  • 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.
  • 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.

Skills and 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.
  • Produces high-quality work on complex problems with cross-functional involvement. Anticipates and proactively prevents risks and compromises to quality

If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.