This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.
Our client is a clinical-stage neuroscience company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, life-threatening diseases. This position is accountable and responsible for leading GMP and GDP Quality operations for worldwide clinical programs.
- Lead and strategically interface with the Technical Operations team responsible for GMP and GDP oversite of CMO’s. Responsibilities include vendor interface, vendor audits, product disposition activities, and progressing the associated GMP and GDP elements of company Quality Management System.
- Responsible for managing GMP change controls internal to both the company and from CMOs.
- Development, reporting, and analysis of associated Quality metrics.
- Review clinical and commercial enabling regulatory submissions and facilitate responses to Regulatory Agencies for any submission inquiries or inspection findings as required.
- Stay abreast of changes in European and FDA regulations, directives and guidelines, and determine the impact on GMP, GDP operations, and deliverables. Maintain comprehensive knowledge of applicable regulatory requirements and their interpretation.
- Build and foster collaborative relationships with key stakeholders across the business.
- In conjunction with the Quality Head, promote an engaged quality culture across the company and contribute to management reviews taking into consideration GMP and GDP quality metrics, results of internal audits and external inspections, industry trends, and the external regulatory environment.
- Provide leadership and guidance in the timely communication/escalation to the Quality Head and Management of issues associated with regulatory compliance.
- Assure a state of compliance and readiness for Health Authority inspections and internal audits.
- Build and lead a team of engaged quality professionals.
- Other duties as assigned.
- Travel ~25% as requested
- Extensive experience in implementing, interpreting, and providing guidance on applicable domestic and international regulations. Experience with GMP/GCP/ICH standards and regulatory guidance documents.
- Demonstrated ability to effectively collaborate and partner with functional management while maintaining an appropriate assertive style.
- Well-organized and detailed oriented professional with strong verbal and written communication skills.
- Strong cross-functional collaboration skills with emphasis on Project Management and Process Excellence.
- Strong computer skills with experience and working knowledge of MS Office (Word and Excel, Access, Adobe Acrobat professional), Veeva Quality Vaults, and ComplianceWire).
- 10+ years of experience in the pharmaceutical industry, with 5+ years of experience directing multiple Quality Management functions and staff including such areas as; QMS leadership, GMP/GDP management, risk management, vendor management, inspection readiness and recruiting, managing and developing high-performance
- Bachelor’s degree in a scientific discipline, with an advanced degree,
- QP certification preferred.
- Demonstrated ability to build trusted partnerships across the business furthering an engaged quality culture
- Demonstrated ability to drive strategic decision making when presented with complex problems or deliverables.
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