Head of Quality - Biologics - Cell & Gene

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) 514-9604, or email dfearnley@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