Director, Quality Assurance | Cutting-Edge Gene Therapies | Innovative & Quickly Growing Biotech | NJ
Our client is an exciting, innovative, and rapidly-growing biotech company (publicly-traded) that focuses on developing novel “first-in-class” gene and cell therapy treatments for life-threatening rare diseases. This is a highly visible role where you will manage multiple projects and coordinate with key internal and external stakeholders to advance a transformative portfolio of potentially-breakthrough gene therapy programs. You will report directly into the COO and work closely with other Executive Management Team members.
This is a very exciting time within the organization as they are growing across a number of departments, and this is a great opportunity to join an exciting company at the early stage in its growth and have the ability to truly impact the organization. This company has been attracting experienced and talented industry professionals and offers a small team camaraderie and fast-paced/collaborative work environment, while also having a diverse development pipeline and an impressive leadership team.
Attractive Features about this Company & Opportunity:
- Great Time to Join: This is a perfect time to join this exciting high-growth biotech company, as they are still small and nimble. You will have much more opportunity to grow and diversify your experience than at a larger, more compartmentalized company.
- Exciting Biotech Culture: The company offers all the attractive features sought with an entrepreneurial development/clinical-stage Biotech (small team comradery, impact, nimble, quick decision-making, autonomy, minimal layers/bureaucracy) which fosters more collaboration, communication and swifter decision making (i.e. emphasis on progress and moving things forward).
- Cutting-Edge Science & Gene Therapies: Leveraged by its unique technology and cutting-edge science, this company is on the forefront of a novel approach to cell/gene therapy treatments, opening up a vast domain for discovering innovative new medicines. A handful of their compounds have recently been granted “Fast-Track” status / Orphan Drug designation.
- Ability to Make a Real Difference: As opposed to being a small fish in a big pond in Big Pharma, you will work in a lean, entrepreneurial and collaborative environment where you will have the autonomy and visibility to make a significant impact on the company’s success, as well as in the lives of patients suffering from devastating rare diseases.
- The primary responsibility of this position is to ensure gene therapy assets meet the established standards of quality including reliability, usability and performance.
- Develop the company’s strategic Quality vision, including Corporate Quality, GCP, GLP and GMP compliance systems, SOPs and staff, to support the company’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.
Education & Desired Experience:
- Bachelor’s degree in a scientific or life sciences discipline. Advanced degree is preferred.
- 7+ years of relevant QA experience at a pharmaceutical and/or biotech company.
- Experience working with Quality systems in support of gene therapy development programs preferably in the biotechnology industry.
- Gene or cell therapy experience is strongly preferred.
- Working knowledge of US and EU cGMPs.
- Experience managing CMO/CRO relationships and projects.
- Ability to thrive in a fast-paced environment combining strategic and tactical capabilities.
Brian Skurka, Partner
firstname.lastname@example.org – P 973-656-0220 x738
Cornerstone Search Group, LLC
6 Campus Drive
Parsippany, NJ 07054
Keywords: QA, Quality Assurance, Director, Associate Director, Senior Manager, rare diseases, gene therapy, cell therapy, orphan drugs, quality systems