Job Title: Director of Quality
Start-up ocular therapeutics company developing novel gene-based therapies for retinal disorders that lead to vision loss. They have exclusive licences to intellectual property relating to several near-to-clinic gene-based therapies for conditions. Building an integrated, global gene therapy business that brings together therapeutic and platform-based technologies along with extensive clinical, manufacturing and commercial experience.
Must have an established track record in delivering robust and regulatory compliant QMS. The successful candidate must have experience in GCP, GLP and GMP. Proven track record in delivery of validating and registering manufacturing facilities with the regulatory authorities (MHRA and FDA).
The role is required due to the Company embarking on the setting up of their internal Manufacturing Facility for the manufacture of Advanced Therapies (Gene Therapy viral vectors). The facility is planned to manufacture Phase I and II clinical material with the ambition to make Phase III and commercial supply for its in-house programmes. To put “best practice” in quality in place for a Gene Therapy start up business.
PiR is a specialist recruitment company, established for over a decade, focused exclusively on identifying senior talent who deliver strategically and operationally to international life sciences organisations.
The relevance and depth of PiR’s expertise is reflected in the team’s combined life science recruitment experience of over 40 years; across key business functions at leadership and expert level. Our exclusive focus on, and network in, the sector ensures our solutions are aligned and relevant to client companies, reflecting our inherent understanding of the life science industry.
PiR’s client services include:
• Executive Search
• Interim Management Services
• Talent Mapping
PiR’s team is aligned to provide a depth of expertise across key business segments:
• Early stage, investor backed and SME organisations, as well as mid-capped specialist companies. These include advanced and novel therapies (cell, gene, and RNAbased), orphan drugs and innovative medical technology
• Building senior teams for newly funded and growing organisations
• Director, leadership and expert level; Medical/Medical Affairs, Clinical, Regulatory, Manufacturing Operations (including Quality and Supply Chain) and Commercial (HEOR, Pricing & Reimbursement, Market Access, product management)
• Board level appointments (CEO, CBO, COO, CSO, CMO, Chair, NED)
To learn more about PiR, please contact Sally Hope, CEO at email@example.com. Tel: + 44 (0) 1480 499580