(Sr) Manager, Clinical Quality Assurance Compliance
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.
- 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.