Job Details
Head of Quality - Biologics - Cell & Gene
Head of Quality required to work for a niche Cell & Gene Therapy Biotech. Their focus has been on using a CRISPR discovery platform to decipher the genome to identify gene targets. Due to the success of their business, they're now growing their GMP manufacturing for late-stage clinical and commercial cell therapy.
They consistently collaborate with some of the biggest names in Life Sciences
JOB TITLE
Head of Quality / VP of Quality
LOCATION
USA / California / Bay Area / CA
SALARY
$200K - $250K + bonus and package
ROLE/DESCRIPTION
- Highly visible role reporting directly to the C-Suite to establish and grow the quality and regulatory functions for the business
- You will spearhead, implement, and develop a quality management system (QMS)
- Oversee all QA activities throughout the product lifecycle, from early clinical to commercial phase
- Be the primary liaison for the regulatory teams and ensure timely support of regulatory CMC filings, IND/IMPD and associated updates.
- Communicate regulatory requirements to internal & external stakeholders, providing guidance on compliance strategies and regulatory risks
- Conduct internal audits and oversee external audits from clients, regulatory agencies, and partners
- Recruit and develop a high-performing team of quality professionals
REQUIREMENTS
- Minimum of 15 years experience in Biotech Quality Assurance & CMC
- Bachelor's degree in a science discipline
- Recent exposure to Cell & Gene therapy, CRISPR and/or Genomics
- In-depth knowledge of global regulations governing cell and gene therapy products
- Strong leadership and communication skills
ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA, Europe and Asia Pac. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
www.i-pharmconsulting.com
TO APPLY
If you would like to discuss this vacancy further, please call Principal Consultant David Fearnley on +1 (718) ###-####, or email ...@i-pharmconsulting.com. If this role is not suitable, David is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
KEY WORDS
Quality Assurance / Head of QA / Quality Assurance Director / Genomics / Drug Discovery / CRISPR / Immuno-Oncology / Therapeutics / Qualification / SOP / Quality / QA / ISO / ISO 9001 / GMP / QSR / product life cycle / full life cycle / GLP / Good Manufacturing Practice / Biologics / QMS / Cell & Gene
Desired Skills and Experience
Minimum of 15 years experience in Biotech Quality Assurance & CMC
Bachelor's degree in a science discipline
Recent exposure to Cell & Gene therapy, CRISPR and/or Genomics
In-depth knowledge of global regulations governing cell and gene therapy products
Strong leadership and communication skills