Under the supervision of the Head of Development, the Director of QA will proactively manage multiple projects and coordinate with key internal and external stakeholders to advance a transformative portfolio of both LVV and AVV programs. The primary responsibility of this position is to ensure gene therapy assets meet the established standards of quality including reliability, usability and performance. The ideal candidate for this position will have at least 4 years’ experience working with Quality systems in support of viral vector gene therapy development programs preferably in the biotechnology industry.
- Develop the company’s strategic Quality vision, including Corporate Quality, GCP, GLP and GMP compliance systems, SOPs and staff, to support Rocket’s growing portfolio of clinical development programs.
- Provide operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints.
- Strategically partner and align the with Process Development, Preclinical, Technology Development, QC, Regulatory, and Program Management to implement development strategies and ensure quality is embedded in all aspects of ongoing and planned clinical, nonclinical, and development GXP activities.
- Ensure that manufactured gene therapy products are of high quality, safe for human use, and are in compliance with cGMP and international regulations.
- Collaborate with regulatory to support IND/NDA/MAA filings/amendments on CMC sections.
- Promote a culture of quality and operational excellence.
- Extensive experience in the biotechnology or biopharmaceutical manufacturing industry with prior experience in QA focused on gene therapy (AAV or LVV preferred)
- Working knowledge of US and EU cGMPs
- Experience managing CMO/CRO relationships and projects
- Thrive in a fast-paced environment combining strategic and tactical capabilities
- Excellent written and verbal communication skills, analytic and problem-solving
- BA/BS/University degree in Life/Health Sciences required; advanced degree preferred.
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs.
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to email@example.com