Please see below for our current openings and email your CV to firstname.lastname@example.org if you’d like to apply. We are always looking for talented individuals to join our team, so even if you don’t see a job description below that is a good fit, we would still encourage you to reach out to us.
Manager, Quality Assurance and Regulatory Affairs
The Manager of QA/RA will be responsible for building, developing, implementing and maintaining a Quality System that spans R&D, Manufacturing and Clinical activities. He/she will also need to instill quality aspects throughout the company culture, extending to vendors, suppliers and consultants. Secondarily, the Manger will coordinate regulatory activities. As this is the company’s first Quality / Regulatory full time position, a broad, working knowledge of key aspects of both disciplines will be required. The immediate need and focus will be in Quality (Assurance) Systems, with the Regulatory responsibilities increasing over time. Strong organizational, leadership and team skills will be important to guiding and aligning the internal team and external consultants.
- Quality Systems
- Build, develop, implement and maintain a Quality System that spans R&D, Manufacturing and Clinical activities; broad working knowledge of key elements of Quality Systems
- Generate and review documents used in current Good Manufacturing Practices (cGMP) and Good Clinical Practices.
- Draft and implement quality documentation and training, including SOPs, test methods, change controls, deviations, corrective actions, out of spec investigations, etc. Maintenance of quality documentation per CFR requirements.
- Implement device and biologic frameworks Design Control and/or Quality by Design per CDRH / CBER industry guidance. Must be able to guide team through phases, understand documentation and testing requirements, and maintain files.
- Maintain equipment certifications
- Organize Document Controls to capture key internal supporting docs and external vendor quality specifications
- Audit raw material vendors, prepare manufacturing documentation for updated filing. May lead investigations and resolve potential product quality issues to improve efficiency.
- Review manufacturing documents for material qualifications and products
- Coordinate filing of amendments to regulatory agencies. This includes preparing documentation for regulatory review as well as interacting with the FDA (ie, meeting requests, filings etc).
- Institute document control paradigms for regulatory function
- Serve as Project Manager for IND development and filing
- Manage meeting requests, and track information exchange with FDA
- Leverage Sentien external regulatory consultant, seeking timely guidance on key issues as required
- Strong organizational and communication skills, both written and presentation.
- Able to work with a diverse group of individuals and styles, internal employees and external consultants. Efficiently coordinates group, synthesizing input and nominates clear path forward.
- Respect and adherence to timelines
- Excited for start-up culture: adaptability, occasional ambiguity, limited resources, willingness to do what is necessary to get the job done
- Self-motivated, willing to learn
- Bachelor’s degree in a scientific discipline (e.g., Biology, Biomedical Engineering)
- 5+ industry experience with a clinical stage biotechnology company
- Experience with biologics (e.g., mAbs) a minimum, with cell or gene therapies preferred (basic cell culture, testing and analytical methods)
- Strong knowledge of FDA / GMP regulations required; EU / ICH a bonus
- Understanding of Investigational New Drug (IND) process
- Understanding of CBER / Biologics Licensing Application regulatory framework; CDRH / medical device regulation familiarity also ideal (i.e., combination products).
- Familiarity with MS Office / Google Docs, MS Project / Asana a plus