Quality Assurance Manager (Quality Assurance Analyst)

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services' experts create solutions customized to the client's needs.

Summary:

This Quality Assurance role for the JPM CBRN Task Order 3 contract in the RAQA Program Office shall perform at a subject matter expert level by providing advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.

Essential Job Functions:

• Serve as a liaison between the AJPEO MRAS regulatory office and product leads to ensure DoD-funded regulatory Sponsors developing MCMs are complying with relevant laws, regulations, and current guidances.
• Advise AJPEO MRAS regulatory team on critical programmatic and project level quality issues.
• Provide training and advisement to DOD staff on regulations, compliance to government regulations, and interactions with quality and manufacturing contacts at contract facilities.
• Conducts quality audits and oversight, as assigned for non-clinical and/or clinical and/or manufacturing activities in compliance with relevant laws, regulations and policies.
• Lead the development and review of regulatory document for submission to FDA or other National Regulatory Authorities (NRAs) and coordinates/prepares and maintains FDA filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.) in accordance with US FDA or other National Regulatory Authority requirements and with the eCTD submission format, as applicable.
• Review, draft, manage, maintain and retain regulatory documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in the in accordance with approved business rules in the assigned electronic document management system.
• Contribute to the modification, development and implementation of internal policies and procedures (such as SOPs)
• Develop and implement regulatory strategies for launching new products and maintaining existing products and provide review, comments and approval of all product claims for technical accuracy and regulatory compliance.
• Represent the regulatory team, provide regulatory guidance to assigned product teams, and facilitate cross-communication with the interdisciplinary team. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner and participate in regulatory audits/inspections as required.
• Plan, prepare and execute for meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies.
• Create and/or review acquisition and contract documents (e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).) to ensure regulatory and quality requirements are appropriate and consistent with FDA regulations and assess the impact of these requirements to the product development timeline.
• Collaborate and network with internal/external regulatory professionals and clinicians, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious Disease (EID), and other relevant emerging and re-emerging threat spaces.
• Travel for presentations and seminars and conduct and provide oversight of supplier evaluation visits (e.g., due diligence, mock audits, vendor qualifications, etc.).

Necessary Skills and Knowledge:

• Advanced knowledge and understanding of GxP regulatory requirements and implementation (FDA, ICH and other relevant guidance governing GxP activities)
• Proficiency with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.

Minimum Qualifications:

• Bachelor and/or Masters in a Science, Engineering or a related discipline is required, ideally in Quality or Pharmacy
• Minimum 7+ years' experience in Biotech/Pharmaceutical industry
• Extensive GxP quality experience in clinics and post-marketing
• Experience working with Contract Organizations, Service Providers, and other entities which provide GxP contracted services.
• Experienced understanding of drug-candidate development
• Technical Competency: GMP, GDP, GCP, GLP, ICH, Quality Audits, Quality Reviews, Experience with computerized systems and GxP compliance requirements, involving both on-premises and hosted environments.
• Experience with medical product development requirements under the FDA Animal Rule regulatory pathway, including animal model development, pharmacokinetics, pharmacodynamics, and toxicity desired.
• Clearance: Secret

Pay and Benefits

The annual salary range for this position is $130,000 - $170,000.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.